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McLean, L.M., Walton, T., Rodin, G., Esplen, M.J., & Jones, J.M. (2011). A couple-based intervention for patients and caregivers facing end-stage cancer: Outcomes of a randomized controlled trial. Psycho-Oncology, 22, 28–38.

Study Purpose

To examine the hypothesis that following an emotionally focused therapy (EFT), the intervention group for patients with metastatic cancer and their caregivers would demonstrate a greater increase in marital functioning postintervention when compared to the control group

To examine whether the intervention group would have a greater decrease in depression, hopelessness, and spousal caregiver burden scores and greater increase in patients’ perceptions of spousal caregiver empathic behaviors as compared to the control group

Intervention Characteristics/Basic Study Process

Potential participants included those who had requested a psychosocial referral for couple distress or those whom doctors had referred to the Psychosocial Oncology and Palliative Care Program. Couples were assigned to the EFT intervention or the control standard of care group. Randomization was stratified by sex.

The EFT intervention, which was adapted for use with couples experiencing metastatic cancer, was delivered over eight sessions. The modified manualized EFT addressed particular issues that challenge such couples and were used in prior research. These included ways to facilitate marital relationships by changing habitual and distressing patterns of interaction, increase mutual understanding and emotional engagement, and strengthen the marital bond. Couples had a one-hour weekly session delivered by a trained psychologist in a clinic outpatient or other convenient location over a period of two to three months.

The control group received standard of care from the institutional Psychosocial Oncology and Palliative Care Program. Social work consultation in that facility accounts for two-thirds of psychosocial care and usually involves practical and instrumental care or supportive interactions to relieve patient and family psychological distress. Patients and their partners facing metastatic cancer may be followed by a multidisciplinary team on a weekly, biweekly, or until end-of-life basis and as defined by patient/clinician assessment.

Sample Characteristics

  • The sample included 42 patient/caregiver dyads (22 in the EFT group and 20 in the control group).
  • Mean age of patients was 51 years; mean age of caregivers was 50 years.
  • The patient sample was 45% male and 55% female; the caregiver sample was 55% male and 45% female.
  • Patients mainly had breast (23%), blood (17%), gynecologic, (14%), and head and neck (10%) cancers.
  • Of the patients, 42% had some college education or a college degree, spoke English, and were not in active treatment. Similar results were noted in caregivers.

Setting

  • Outpatient
  • Home setting
  • Toronto, Ontario, Canada

Phase of Care and Clinical Applications

  • End-of-life phase
  • Caregiver burden; depression; marital functioning

 

Study Design

A randomized, controlled, two-group trial design was used.

Measurement Instruments/Methods

  • Beck Depression Inventory II: Used extensively in cancer populations; Cronbach’s alpha in prior studies = 0.92
  • Beck Hopelessness Scale: Used in terminally ill populations; prior Cronbach’s alpha = 0.88
  • Caregiver Burden Scale: “Demand” subscale prior Cronbach’s alpha = 0.92; “difficulty” subscale prior Cronbach’s alpha = 0.93
  • Relationship-Focused Coping Scale: Measured patient’s perception of caregiver empathic behavior; prior Cronbach’s alpha = 0.89
  • Revised Dyadic Adjustment Scale (RDAS): Used to screen couples for study inclusion; Cronbach’s alpha in current study = 0.90; has validity from prior studies  

Results

Patients with metastatic disease and their spouses who received the modified EFT had significant improvements in martial functioning compared with those couples who received standard care (p < 0.0001). Additionally, patients in the EFT intervention group reported significant improvement in their assessment of perceived caregivers’ empathetic behaviors when compared with the control group (p = 0.02). On the basis of initial RDAS scores, 91% of the intervention patients improved RDAS scores as compared to 28% of control patients (p < 0.0001). Fifty percent of EFT caregivers improved their RDAS scores as compared to 11% of control caregivers (p = 0.01). The study had a high participation rate and retention of couples. After the EFT and control interventions, there was no difference between groups in caregiver burden, hopelessness, or depression.

Conclusions

A modified EFT intervention was beneficial for patients with advanced cancer and their caregivers and improved both quality of martial functioning and patients’ perceived experience of being empathically understood by their caregivers. There were no apparent effects on caregiver strain and burden.

Limitations

  • The study had a small sample.
  • Couples were referred by their clinical team and met a cutoff for marital distress, thereby limiting generalizability (no attentional control).
  • The control intervention standard of care varied because of clinician decision of care deemed suitable for the client.
  • Participants were not blinded to the intervention.

Nursing Implications

Recent trends toward longer survival and home care for patients with advanced cancer place emotional, relationship, and physical demands (burden) on the primary caregiver, who in many cases is the spouse or partner. An intervention that improves martial functioning may impact terminal care and patient satisfaction with spousal care, as well as reduce caregiver burden. Nursing assessment of marital or patient–caregiver relationships and referral to relevant resources may enhance the quality of life of both patients and caregivers and meet a standard of care for holistic nursing care.

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McGuire, D.B., Fulton, J.S., Park, J., Brown, C.G., Correa, M.E.P., Eilers, J., . . . Lalla, R.V. (2013). Systematic review of basic oral care for the management of oral mucositis in cancer patients. Supportive Care in Cancer, 21, 3165–3177.

Purpose

STUDY PURPOSE: To systematically review oral care interventions for the prevention and treatment of oral mucositis (OM) in patients undergoing cancer treatment

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: Ovid MEDLINE

KEYWORDS: mucositis, stomatitis, cancer, oral care, oral care protocol, dental care, dental cleaning, oral decontamination, oral hygiene, saline, sodium bicarbonate, baking soda, chlorhexidine, magic/miracle mouthwash, calcium phosphate

INCLUSION CRITERIA: Primary research article, reflects a variety of research designs, rested the effects of intervention on severity of OM or mucositis-related symptoms

EXCLUSION CRITERIA: Review articles, clinical case reports, literature reviews, non-research articles

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 129

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Hadorn et al. criteria was used to assess the flaws in the selected publications, and levels of evidence were rated using the Somerfield schema.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 52

SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: Not stated

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

The guidelines are as follows.

  • Oral care protocols: Oral care was suggested for the prevention of OM in adult and pediatric populations for all types of cancer therapies. No population-specific guidelines were recommended.
  • Dental care (by a professional): No guidelines were recommended for dental care in the prevention of OM.
  • Normal saline: No guidelines were recommended for normal saline for the prevention or treatment of OM.
  • Sodium bicarbonate rinse: No guidelines were recommended for sodium bicarbonate for the prevention or treatment of OM.
  • Chlorhexidine: No guidelines were recommended for chlorhexidine for the prevention or treatment of OM in patients receiving standard chemotherapy or hematopoietic stem cell transplantation. Guidelines suggest that chlorhexidine not be used to prevent OM in patients with head and neck cancer treated with radiotherapy.
  • Mixed medication mouthwash: No guidelines were recommended for mixed medication mouthwash for the prevention or treatment of OM.
  • Calcium phosphate: No guidelines were recommended for calcium phosphate for the prevention or treatment of OM.

Conclusions

Oral care protocols are recommended to patients for the prevention and treatment of OM. Chlorhexidine is not recommended for patients with head and neck cancer who receive radiotherapy treatment.

Limitations

Evidence for interventions to prevent and treat OM are limited, making guideline recommendations difficult.

Nursing Implications

Nurses should teach patients appropriate oral care to help prevent OM.

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McGreevy, K., Hurley, R.W., Erdek, M.A., Aner, M.M., Li, S., & Cohen, S.P. (2013). The effectiveness of repeat celiac plexus neurolysis for pancreatic cancer: A pilot study. Pain Practice, 13, 89–95.

Study Purpose

To determine the success rate and duration of relief following repeat celiac plexus neurolysis (CPN) for pancreatic cancer pain

Intervention Characteristics/Basic Study Process

CPN was performed using either fluoroscopy or computed tomography (CT). All CPN and neurolytic procedures were performed under sterile conditions with IV sedation provided as needed at the discretion of the attending physician. The decision to use fluoroscopy versus CT was based on several factors, including patient condition, resource availability, and radiologic demonstration of tumor distribution. A diagnostic/prognostic block was performed first; in patients who obtained relief, subsequent neurolysis with 80%–100% ethanol was administered. Volume was variable and dependent on clinical circumstances. All procedures were performed in the prone position using a posterior approach. Patients were kept prone for 30 minutes to avoid spread to posterior nerves.

Sample Characteristics

  • N = 24
  • MEAN AGE: Participants with negative outcome (defined as less than 50% pain relief in less than one month following repeat CPN procedure) = 52.4 years; those with positive response = 59 years
  • MALES: 62.5%, FEMALES: 37.5%
  • KEY DISEASE CHARACTERISTICS Pancreatic cancer (unresectable) with moderate-to-severe abdominal and/or back pain poorly controlled with pharmacotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Severe, persistent pain; end-stage pancreatic cancer pain management
  • EXCLUSION CRITERIA: Untreated coagulopathy, unstable medical illness, cognitive impairment that precluded an accurate response assessment

Setting

  • SITE: Single site 
  • SETTING TYPE: Outpatient
  • LOCATION: Baltimore, MD

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late/end-stage, end-of-life care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Prospective, descriptive

Measurement Instruments/Methods

  • A successful procedure was defined as 50% or more pain relief for one month or longer after repeat CPN.
  • Baseline 0–10 Numeric Rating Scale pain score

Results

Those participants with a successful response to initial CPN were more likely to have pain symptoms in the back and abdomen and have a shorter time interval from diagnosis of pancreatic cancer to initial CPN. The overall success rate decreased from 67% after initial CPN to 29% following repeat CPN (p = 0.13). The mean duration of pain relief also decreased from 3.4 months following initial CPN to 1.7 months after repeat CPN (p = 0.03). The proportion of individuals with successful repeat CPN after unsuccessful initial CPN was 50% (four out of eight), which favorably compared to 19% (3 out of 16) in those who had successful initial CPN (p = 0.13). In multivariate analysis, the presence of metastases was associated with a 90% decrease in success rate. No statistically significant differences were found between repeat CPN success, and failure groups were observed for age, sex, baseline pain score, location of tumor, presence of metastasis, encasement of celiac axis, opioid use, peritoneal tumor involvement, use of repeat diagnostic block, radiologic guidance used for procedure, needle approach or technique used, or the use of sedation for the procedure. Disease progression on imaging and a longer period between blocks were contributors to treatment failure.

Conclusions

This study demonstrated that the magnitude and duration of pain relief following repeat CPN were significantly less than after the initial procedure. Results suggest that a subset of patients may benefit from repeat CPN. Thirty percent of individuals reported positive responses to repeat CPN, which warrants further analysis.

Limitations

  • Small sample (less than 30)
  • Measurement/methods not well described
  • Other limitations/explanation: Because of the infrequency with which repeat CPN is performed and the patient population involved, a randomized study was deemed impractical. This research did not contain any objective documentation of functional improvement or quality of life.

Nursing Implications

Evaluation of a repeat procedure may be warranted when pain levels begin to escalate following a successful initial procedure. However, this is a preliminary suggestion warranting more well-controlled studies. As patient advocates and proponents of pain management, nurses are in a position to further research regarding patient responses to pain management interventions and techniques, such as CPN and repeat CPN. In the outpatient setting, oncology nurses focus on pain management at every visit and direct patients to follow up with the appropriate interdisciplinary team member(s) to address as needed. Nurses are involved in every aspect of patient care, including pre-, post-, and during interventions (e.g., the various CPNs described here), and in outpatient, inpatient, hospice, and palliative settings.

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McGough, C., Wedlake, L., Baldwin, C., Hackett, C., Norman, A.R., Blake, P., … Andreyev, H.J. (2008). Clinical trial: Normal diet vs. partial replacement with oral E028 formula for the prevention of gastrointestinal toxicity in cancer patients undergoing pelvic radiotherapy. Alimentary Pharmacology & Therapeutics, 27(11), 1132–1139.

Study Purpose

To determine whether replacing a third of the normal diet with an elemental formula (E028) during the first three weeks of pelvic radiotherapy is feasible and effective in decreasing acute gastrointestinal (GI) toxicity

Intervention Characteristics/Basic Study Process

Patients with a gynecologic, urologic, or lower GI malignancy who were scheduled to receive radical or adjuvant radiotherapy to the pelvis were randomized to receive either an elemental diet, which involved replacing one normal meal per day with the elemental formula E028 Extra, or no intervention for the first three weeks of treatment.

Sample Characteristics

  • The study reported on 50 patients with a median age of 61.5 years.
  • The median age of patients in the intervention group was 62.5 years with a range of 29–79.
  • The median age of patients in the control group was 58 years with a range of 38–82.
  • The intervention group had 17 female and 8 male patients. The control group had 12 female and 13 male patients.
  • Patients had been diagnosed with gynecologic, urologic, or lower GI malignancies and were schedule to receive radical or adjuvant radiotherapy to the pelvis.

Setting

The study was conducted in an oupatient care setting in the United Kingdom.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a prospective, randomized-controlled trial.

Measurement Instruments/Methods

The Inflammatory Bowel Disease Questionnaire – Bowel specific sub-set (IBDQ-B), Vaizey Incontinence Questionnaire (VIQ), and Radiation Therapy Oncology Group (RTOG) tool were used.

Results

  • Intake of the elemental formula was lower than the prescribed volume required to provide a third of caloric requirements. 
  • Bowel symptoms increased significantly in both groups as a result of pelvic radiotherapy. Symptom scores at weeks 3 and 5 were significantly higher than those at baseline for both groups. Changes in symptoms between baseline and week 3 were not significantly worse in the intervention group compared to the control group (p = 0.214).
  • No significant differences were found between groups at baseline (p = 0.632) or at any other timepoints (p = 0.151).

Conclusions

Patients in the intervention group exhibited poor compliance, ingesting only 65% of the proposed oral elemental formula. The intervention group did not experience a reduction in bowel symptoms or fecal calprotectin compared to the control group.

Limitations

  • The sample size was small, with fewer than 100 patients.
  • The study was not blinded.
  • The intervention group included a greater proportion of patients with gynecologic malignancy, and the control group included a greater proportion of patients with urologic malignancy. Because the volume of small bowel in the targeted field and dose of radiotherapy differs according to cancer site, lack of stratification could have had an effect on outcome. Furthermore, results could have been affected by the fact that some of the patients with gynecologic cancers were receiving concomitant chemotherapy while those with urologic cancer were not.

Nursing Implications

This study did not show a benefit to ingesting elemental formula. Orally ingested elemental formulae are known to be unpalatable, and the intervention group had poor compliance with consuming the proposed amount of formula.

Print

McDougall, G.J., Becker, H., Acee, T.W., Vaughan, P.W., & Delville, C.L. (2011). Symptom management of affective and cognitive disturbance with a group of cancer survivors. Archives of Psychiatric Nursing, 25, 24–35.

Study Purpose

To evaluate effectiveness of a memory training intervention as compared to a health training group intervention for management of cognitive impairment in older adult cancer survivors

Intervention Characteristics/Basic Study Process

Measures were performed pre-intervention, post-intervention, post-booster intervention, and six months afterwards. The memory training intervention consisted of eight sessions incorporating 20 minutes of relaxation, a targeted memory topic, and 30 minutes of targeted practice with role model. Participants received a memory improvement book at end of the memory intervention. The health training consisted of providing 18 health-related topics over two months; the frequency of the training was not provided. Booster sessions consisted of four weekly mandatory two-hour sessions over one month conducted within three months after completion of initial training. 

Sample Characteristics

  • A total of 22 patients participated in the study. Eight received the memory intervention, and 14 received health training.
  • Participants' mean age was 73.8 years(SD = 4.82 years).
  • The sample was 41% male and 59% female.
  • Participants had been diagnosed with breast cancer (n = 8), prostate cancer (n = 5), facial or nose basal cell carcinoma (n = 3), uterine cancer (n = 2), leukemia/lymphoma (n = 2), throat cancer (n = 1), or lung cancer (n = 1).
  • 86% of the sample was Caucasian.
  • On average, participants had completed 16 years of education.
  • Socioeconomic status varied among the sample.
  • The length of time from oncology treatment was unknown.

Setting

  • Mutli-site
  • Outpatient setting
  • Austin, TX

Phase of Care and Clinical Applications

  • Patients were undergoing long-term follow-up.
  • The study has clinical applicability for older adult care.

Study Design

Randomized clinical trial

Measurement Instruments/Methods

  • Hopkins Verbal Learning Test–Revised (HVLT-R)     
  • Brief Visuospatial Memory Test–Revised (BVMT-R)
  • Rivermead Everyday Behavioural Memory Test (REBMT)
  • Metamemory in Adulthood QuestionnaireDirect Assessment of Functional Status
  • Memory Self-Efficacy Questionnaire
  • Mini-Mental Status Examination

Results

Visual memory as measured by the BVMT-R was improved (p < 0.1 for the group by time interaction) for participants who received the memory training intervention. Trends toward improvement in verbal memory as measured by the HVLT-R and overall memory as measured on the standardized profile scale of the REBMT were observed for participants who received the memory intervention, but they were not significant. Improvements were seen in self-reported memory components in locus, capacity, and control (p < 0.05 for the group by time interaction) and use of internal strategies (p < 0.1 for time). Memory complaints decreased (p < 0.05 for the group by time interaction). 

Conclusions

Significant improvements in visual memory were obtained and sustained, and trends for improving verbal and global memory were observed in those who participated in the memory training. In addition, those who participated in memory training maintained their use of internal compensatory strategies and reported significant improvements in subjective aspects of cognitive function, including increased confidence, greater capacity, belief that they could better manage issues with their memory, and decreased complaints of their memory performance.

Limitations

  • The sample was small at less than 30 participants.
  • The generalizability of the results was limited.
  • The feasibility of replicating the memory training intervention was limited.

Nursing Implications

Cognitive impairments present ongoing symptom management issues for older adult cancer survivors. Memory training has been effective in older individuals and may offer opportunities for improvements in memory difficulties for older adult cancer survivors. The authors suggested that their memory training intervention may be adjusted to meet the specific cognitive issues that older cancer survivors report. Further studies are needed to determine feasibility and generalizability to patients with cancer.

Print

McDougall, G.J., Jr. (2001). Memory improvement program for elderly cancer survivors. Geriatric Nursing, 22(4), 185–190.

Study Purpose

The study was conducted to determine the effect of a rehabilitative intervention on cognitive function, depression, and functioning.

Intervention Characteristics/Basic Study Process

The study framework included two intervention groups and one wait-list control group. Participants were randomized into intervention group 1 (receiving eight classes and a memory book) or the wait-list control group (Group 3). Wait-list control group participants were further randomized into intervention group 2 (receiving only the memory book) or group 3.

Intervention group 1 received a memory book and classes on day 1; intervention group 2 received a memory book on day 1 and began classes four weeks later. Wait-list control group participants received a memory book on day 1. Participants from intervention group 2 and the wait-list control group were placed in classes together based on location. All classes were identical.

Sample Characteristics

  • The total number of participants was 78.
  • The average partcipant age was 82.
  • There were 58 women and 20 men in the study. 
  • Participants were divided into four groups of chronic conditions for analysis: arthritis (n = 16), cancer (n = 11), heart disease (n = 32), and other (n = 19).
  • On average, participants had attained 15 years of education. 

Setting

The study took place at a comprehensive retirement community in the Midwest that included independent and assisted-living dwellers.

Study Design

The study utilized a randomized, controlled trial.

Measurement Instruments/Methods

  • Mini-Mental State Examination (MMSE) for global cognitive functioning
  • Geriatric Depression Scale for depression
  • Instrumental Activities of Daily Living Scale (IADL) for functional ability
  • Multi-Level Assessment Instrument (MAI) as a health subscale
  • Rivermead Behavioral Memory Test (RBMT)
  • The Metamemory in Adulthood Questionnaire (MIA) was utilized. This 108-item assessment tool has 7 subscales assessing strategy, task, capacity, change, anxiety, achievement, and locus.

Results

Cancer survivors showed significant improvements after the intervention in

  • Memory efficacy (p = 0.05)
  • Metamemory change (p = 0.0001)
  • RBMT Immediate Story Recall (p = 0.006)
  • RBMT Delayed Story Recall (p = 0.002)
  • RBMT Belonging (p = 0.05).

The cancer survivors scored higher on managing finances (p = 0.01). They had lower total IADL scores compared with the control group, and scored lower on baseline metamemory capacity, with an average score of 2.5 (p = 0.03). They showed worsening after the intervention on the RBMT Immediate Route test (p = 0.03) and the RBMT Delayed Route test (p = 0.0001). The cancer survivors were older, with an average age of 84.12 years (p = 0.02). 

Significant associations were observed for the total sample between 

  • IADL scores and memory performance on the RBMT (r = -0.44, p < 0.05)
  • IADL scores and metamemory subscale of change (r = -0.33, p < 0.05)
  • IADL scores and external memory strategy (r = -0.29, p < 0.05)
  • Depression and memory performance on the RBMT (r = -0.31, p < 0.05).

There were no significant pre-test differences between groups on memory performance, memory self-efficacy scores, or MMSE scores. The total sample had a relatively high perception of health status and a low incidence of depression (13%). 

Conclusions

Post-intervention tests showed no improvements in objective memory performance, despite reported improvements in subjective memory and memory self-efficacy.

Limitations

  • This was not a cancer-specific study and had only a small sample of cancer survivors.
  • Cancer diagnoses were not reported, and no information regarding cancer-related treatments was provided.
  • Participants were assigned to the chronic illness categories by the researchers.
  • No listing was provided of the medications taken between groups, which could affect cognitive performance.
  • It was reported that many participants began practicing mental activities and exercises prior to the intervention's initiation, potentially affecting baseline scores for cognitive performance.
  • A documentation of when the post-test was performed was not found.
Print

McDonald, J., Swami, N., Hannon, B., Lo, C., Pope, A., Oza, A., . . . Zimmermann, C. (2016). Impact of early palliative care on caregivers of patients with advanced cancer: Cluster randomised trial. Annals of Oncology, 28, 163–168. 

Study Purpose

To report the effect of an early palliative care intervention on quality of life (QOL) and satisfaction with care of caregivers of patients with advanced cancer

Intervention Characteristics/Basic Study Process

A cluster randomization process involving patients and their caregivers in 24 Canadian medical oncology clinics supported two randomized arms: an intervention with early palliative care team referral or usual oncology care with palliative care only as needed. Further stratification of clinics by tumor site supported the two study arms. Both arms included caregivers of patients with advanced cancer, defined as having a clinical prognosis of 6–24 months and an ECOG score of 0–2, who completed previously validated instruments on care satisfaction (FAMCARE-19) and QOL (SF-36v2 Health Survey, Caregiver Quality of Life Index-Cancer [CQOL-C]). A mixed effect model evaluated intervention group improvement over the control group at baseline assessment and monthly for as many as four months.

Sample Characteristics

  • N = 182, 94 in intervention and 88 in control
  • MEDIAN AGE = 58 years (intervention), 57 years (control) 
  • MALES: 35% (not specifically stated, extrapolated from female percentage), FEMALES: 65% 
  • CURRENT TREATMENT: Not specified
  • KEY DISEASE CHARACTERISTICS: Stage III with poor prognosis or stage IV disease (hormone refractory disease of breast and prostate cancer); cancer diagnoses included lung, gastrointestinal, genitourinary, breast, and gynecologic.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with an ECOG status of 0–2 and who passed a cognitive screening (Short Orientation-Memory-Concentration Test, greater than 20 or less than 10 errors)

Setting

  • SITE: Palliative care clinic
  • SETTING TYPE: Outpatient oncology clinics
  • LOCATION: Princess Margaret Cancer Centre, Toronto, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Advanced cancer diagnosis (prognosis of 6–24 months)
  • APPLICATIONS: Palliative care

Study Design

Cluster randomized trial design

Measurement Instruments/Methods

  • Satisfaction in care: 19-item FAMCARE Scale (FAMCARE-19) 
  • QOL measurements: SF-36v2 Health Survey, CQOL-C

Results

Analysis of FAMCARE-19 (satisfaction with care) data showed significant improvement in the intervention group over the control group during the trial period (three months: p = 0.007, four months: p = 0.02). FAMCARE-19 scores were not significantly associated with the number of caregiver palliative clinic visits (three months: p = 0.21, four months: p = 0.39). The intervention and control groups did not differ significantly during the study time on SF-36 physical component scores, the SF-36 mental component scores, and CQOL-C scores. Despite improvements in early palliative care team referral group satisfaction with care, the authors were unable to conclude whether such care improved that caregiver group’s QOL. An exploratory analysis of FAMCARE-19 domains showed that the group’s greatest improvement over that of the usual care group was in four areas: depth of doctor’s patient symptom assessment (p = 0.004), family knowledge of patient tests (p = 0.02), specialist referral (p = 0.02), and family access to nursing services (p = 0.01).

Conclusions

Canadian caregivers of patients with advanced cancer that receive early palliative care team intervention experience increased satisfaction with care compared to those who receive standard oncology care. Additional work to explore the impact of an early palliative care team intervention on caregiver QOL with an attention on factors like sample size and contextual factors of care will contribute to the science in this area.

Limitations

  • Risk of bias (no blinding) (no full blinding due to cluster design
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%  (17% attrition after baseline assessment)
  • Recruitment from a single cancer center
  • The intervention was complex, and no measurement of dosage of ancillary interventions, which included qualitative interviews, was included.

Nursing Implications

Few clinical trials assess the effect of early palliative care interventions on caregivers of patients with advanced cancer. Current standards of care for patients with advanced cancer include integrating palliative care to improve patient care satisfaction and QOL. This study shows evidence that including those patient caregivers in such an approach improves their satisfaction with care, although it is unclear whether it improves their overall QOL.

Print

McDonagh, M., Peterson, K., & Thakurta, S. (22 July, 2010). Consideration of evidence on antiemetic drugs for nausea and vomiting associated with chemotherapy or radiation therapy in adults. Rockville, MD: Agency for Healthcare Research and Quality. Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK254005/

Purpose

STUDY PURPOSE: To compare the benefits and harms of antiemetic regimens using 5HT3 antagonists plus corticosteroids with or without aprepitant in patients receiving chemotherapy or radiation therapy
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE and the Cochrane databases
 
KEYWORDS: Aprepitant, dolasetron, granisetron, ondansetron, palonosetron, chemotherapy, radiation, radiotherapy, neoplasms, antineoplastic agents, nausea, and vomiting
 
INCLUSION CRITERIA: English, humans, and 2008–2009
 
EXCLUSION CRITERIA: Use a 5HT3 antagonist alone or in combination with another noncorticosteriod drug; unclear dosage form or variable route

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 510
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Research articles were identified based on the inclusion and exclusion criteria. The articles' strength of evidence was graded by guidelines established for the Evidence-Based Practice Center Program of ​the Agency for Healthcare Research and Quality (AHRQ). AHRQ grades strength of evidence on risk of bias, consistency, directness, and precision of evidence. Grades of evidence include high, moderate, low, and insufficient. 

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 26
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not stated
  • KEY SAMPLE CHARACTERISTICS: Adults at risk for nausea related to chemotherapy or radiotherapy

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Using the inclusion and exclusion criteria, 26 articles were identified. Articles included head-to-head trials, active-controlled trials, placebo-controlled trails, observational studies, pooled-analysis trials, and data submitted by drug companies. Tables of evidence were constructed, and evidence was graded using guidelines established for AHRQ. Relevant statistical analyses (e.g., random-effects models, Forest plots, Q statistic, I2 statistics) were done when applicable.
 
For total control of nausea and vomiting (no emesis, no use of rescue medications, and only mild nausea) and complete response (no emesis and no rescue medication), evidence strongly recommended three-drug antiemetic regimens containing aprepitant compared to two-drug regimens without aprepitant. Evidence suggested that three-drug antiemetic regimens containing aprepitant can produce total control or complete response if given IV or as mixed PO and IV routes. If given exclusively PO, the three-drug regimen produced no differences for total control compared to the two-drug regimen.

Conclusions

The strongest evidence suggested that three-drug regimens (5HT3 antagonists plus corticosteroids and aprepitant) with mixed delivery methods (PO plus IV) offered maximal relief of chemotherapy-induced nausea and vomiting (CINV).

Limitations

  • The evidence combined patients receiving chemotherapy and radiotherapy, so the results may not be completely applicable to CINV.
  • Many of the studies included in this review had a low strength of evidence in the AHRQ grading system.

Nursing Implications

The addition of aprepitant to standard antiemetic regimens with mixed PO and IV antiemetics can greatly improve CINV in patients with cancer.

Print

McCorkle, R., Siefert, M.L., Dowd, M.F., Robinson, J.P., & Pickett, M. (2007). Effects of advanced practice nursing on patient and spouse depressive symptoms, sexual function, and marital interaction after radical prostatectomy. Urologic Nursing, 27, 65–77; discussion 78–80.

Study Purpose

To determine the effect of a standardized nursing intervention on protocol (SNIP) on newly diagnosed men and their female spouses on marital interaction, sexual function, and depressive symptoms following radical prostatectomy over a six-month period

Intervention Characteristics/Basic Study Process

Couples were randomly assigned to an intervention (SNIP) or a usual care group. The usual care group received care according to standards identified by the urology clinic group, and the SNIP group dyads received 16 contacts (twice per week: home visit and telephone call) from an advanced practice nurse (APN) specially trained for the study to deliver an evidence-based protocol. Dyad conversations with APNs evolved from reading of a common public education booklet given to couples during the SNIP intervention. Measurement of outcome variables (depression, marital interaction, and sexual function) occurred in both the usual and intervention groups at baseline and one, three, and six months following radical prostatectomy.

Sample Characteristics

  • The sample was comprised of 107 patient–spouse pairs (54 in the SNIP group; 53 in the usual care group).
  • Of the sample spouses, 82.3% were age 45–64 years; of the patients, 77.6% were age 45–64 years.
  • Spouses were female (100%).
  • Patients all had a radical prostatectomy due to cancer; spouses had one to three comorbidities, although further specifics about the type of morbidities do not appear in the article.
  • Spouses were predominantly white (85.1%), married to the patient (93.5%), had some college education (63.6%), and were employed (57%).
  • Patient and spousal income placed couples in middle to upper socioeconomic class (annual income greater than $50,000).
  • Couples lived within 50 miles of the study centers.

Setting

  • Two academic medical centers
  • Northeastern United States

Study Design

The study design was secondary data analysis of a prospective, randomized clinical trial with repeated measures.

Measurement Instruments/Methods

  • Center for Epidemiological Studies–Depression Scale (CES-D)
  • Center Rehabilitation Evaluation System (CARES): 26 items are representative of two of five subscales that assessed sexual interest/dysfunction and marital interaction. Reliability of the two subscales ranged from 0.66 to 0.85 across measurements collected at one, three, and six months of the study.

Results

Analysis of variance procedures indicated that among patients, outcome measures showed no indication of main effects due to group assignment. However, spouses had significant differences for some of the measures at six months, with the SNIP group spouses having higher depression scores that approached significance. The SNIP spouses also had a higher average sexual function distress score and a significantly higher marital interaction distress score than did the control group spouses. Spouses reported significantly higher levels of depressive symptoms and more marital interaction distress as compared to patients. However, patients reported significantly more sexual function distress than did their spouses. The SNIP intervention had no group effect on depressive symptoms, but such symptoms improved over time in both patients and spouses. The SNIP intervention showed a modest effect on patients’ sexual function and marital interaction over time, with SNIP patients and spouses reporting increased distress. However, control group women reported significantly lower rates of sexual functioning distress over time compared to the SNIP group. Pearson correlations showed patient depressive symptoms related to patient marital interaction, spousal depressive symptoms, and spousal marital interactions.

Conclusions

An intervention such as SNIP can effectively address depressive symptoms of newly diagnosed patients with prostatectomy and their spouses, as well as relevant issues such as patient sexual function and marital interaction that change with radical prostatectomy. A trained nurse, delivering an evidence-based intervention focused on the needs of these dyads, can assist them in understanding expected postsurgical changes and implementing actions to foster hope and recovery within the dyad.

Limitations

  • The study had a limited non-white sample.
  • The study had a small sample size to exert sufficient power to identity significant changes between the SNIP group and the usual care group.

Nursing Implications

Nurses should routinely assess depressive symptoms of patients and their primary support system to define needed interventions during cancer treatment. Patient and spouse (caregiver) teaching about common side effects of cancer treatment, ways of responding to those side effects, and the potential for recovery of earlier functions should be included at each patient encounter. Support groups for both patients and caregivers may further bolster networking with others who have “moved beyond” the early consequences of prostate surgery and offer hope to recent surgical patients and their spouses. An evidence-based intervention delivered by APNs, such as the one used in this study, offers structure and process of care to promote quality care of those individuals.

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McClure, M.K., McClure, R.J., Day, R., & Brufsky, A.M. (2010). Randomized controlled trial of the Breast Cancer Recovery Program for women with breast cancer-related lymphedema. The American Journal of Occupational Therapy: Official Publication of the American Occupational Therapy Association, 64(1), 59–72.

Study Purpose

To determine effect of completion of a recovery program including gentle exercise and deep breathing on breast cancer-related lymphedma

Intervention Characteristics/Basic Study Process

Patients assigned to the treatment group attended biweekly one-hour exercise and educational sessions for five weeks, then followed a three-month self-monitored home program. Those in the treatment group were instructed to complete use of a video and relaxation daily at home. Exercises included gravity-resistive arm movements incorporating shoulder flexion, abduction, and external rotation. Exercise and compression hose adherence was assessed with a self-report tool designed for the study. Control patients received usual care. Patients were assigned into four groups of treatment and controls.

Sample Characteristics

The study sample (N = 32) was comprised of female patients aged 21–80 years with stage I or II unilateral breast cancer-related lymphedema.

 

Setting

The study took place in an outpatient site in Pittsburgh, PA.

Study Design

The study used a randomized controlled single blind trial design.

Measurement Instruments/Methods

  • Bioimpedance differences were compared between the affected and unaffected arm.
  • The Beck Depression Inventory measured severity of depression.
  • The 36-Item Short Form Health Survey (SF-36) measured quality of life.
  • Cone girth was measured.

Results

Bioimpedance mean differences of those in treatment compared with controls showed a positive main effect for treatment (p = 0.049). There was no significant effect on volume measures. Patients who complied with compression demonstrated improvement over time. Range of motion, mood, and quality of life improved in those in the treatment group.

Conclusions

The program of combined exercise activity and self-directed practice related to coping and relaxation were associated with improvement in lymphedema and other symptoms.

Limitations

  • The sample size was small (N < 100).
  • The study had no attentional control.
  • Limited information is provided regarding all aspects of the intervention.
  • Lack of participant binding poses potential for patient self-report measures.

Nursing Implications

Findings support the positive benefit of patient upper-extremity exercises in the management of lymphedema.

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