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Broderick, J.M., Guinan, E., Kennedy, M.J., Hollywood, D., Courneya, K.S., Culos-Reed, S.N., . . . Hussey, J. (2013). Feasibility and efficacy of a supervised exercise intervention in de-conditioned cancer survivors during the early survivorship phase: The PEACH trial. Journal of Cancer Survivorship: Research and Practice, 7, 551–562. 

Study Purpose

To evaluate the feasibility and efficacy of an eight-week, supervised exercise program in deconditioned cancer survivors within two to six months of chemotherapy completion

Intervention Characteristics/Basic Study Process

Twice-weekly, aerobically-based group sessions in a hospital setting for a duration of eight weeks plus a home exercise program.

Sample Characteristics

N = 38  
AGE RANGE = 21–69 years
MALES: 14% (n = 6), FEMALES: 86% (n = 37)
KEY DISEASE CHARACTERISTICS: Solid tumor or lymphoma (patients with Hodgkin’s or non-Hodgkin’s lymphoma who had completed chemotherapy and/or radiotherapy with curative intent within the preceding two to six months)
OTHER KEY SAMPLE CHARACTERISTICS: Modified Bruce Fitness Test result of average, fair, or poor according to predetermined cut-off points for age and gender; left ventricular ejection fraction (LVEF) of > 50% (assessed by a Multi-Gated Acquisition [MUGA] scan); and a body mass index (BMI) < 35 kg/m2. Medical clearance was provided by the treating oncologist of each participant prior to trial enrollment.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Other    
  • LOCATION: Ireland

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

Prospective, two-arm, randomized controlled trial

Measurement Instruments/Methods

  • Feasibility: Demand and recruitment rates
  • Adherence: Heart rate monitor, diaries, observation, and attendance
  • Acceptability: Exit participant interviews
  • Fitness: Modified Bruce Protocol (MBP)
  • Quality of Life: Functional Assessment of Cancer Therapy–General (FACT-G)
  • Fatigue: Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)
  • Physical Health: Physical Function Scale (PFS) of the Short Form (SF) 36
  • Physical Activity (PA): RT3 triaxial accelerometer and self-report using the Godin Leisure Time Exercise Questionnaire

Results

Feasibility: 81% eligible patients were recruited to the study. Conflicting data on drop-outs were presented. Exercise intervention was positively received as noted in exit interviews with subjects. Adherence to supervised and home-based exercise intervention was good (76% to 105%, respectively). There were no statistically significant differences between the groups for any health-related fitness outcomes. Total FACIT and fatigue subscale scores were better in the exercise group at three months (mean difference = 6.2, 95%, CI 1.4–11.0).

Conclusions

Home-based and supervised exercise interventions in carefully-screened, non-older adult patients begun in the early survivorship phase appear to be safe and feasible, possibly lead to improvements in QOL and fatigue. 

Limitations

  • Small sample size (< 100)
  • Baseline sample/group differences of import: Gender, treatment, and stage of cancer
  • Risk of bias (sample characteristics): Gender, treatment, and stage of cancer
  • Key sample group differences that could influence results: Majority of sample was female; there was a disproportionate distribution of radiation/chemotherapy-treated patients and patients with late/early-stage in exercise and control groups.
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%: The explanation of withdrawals and reasons do not match the number of subjects that completed assessments at each phase.
  • Other limitations/explanation: Variability of activities for home exercise program.

Nursing Implications

Data support the benefit of exercise to address cancer-related fatigue in the early survivorship period. However, sample was “healthy” with few co-morbidities and, although deconditioned, did not include older adults (> 65 years of age), which raises questions about safety and which type and dose of exercise should be recommended to the large group of cancer survivors who continue to experience cancer-related fatigue.

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Brocken, P., Prins, J.B., Dekhuijzen, P.N., & van der Heijden, H.F. (2012). The faster the better? A systematic review on distress in the diagnostic phase of suspected cancer, and the influence of rapid diagnostic pathways. Psycho-Oncology, 21(1), 1-10.

Purpose

STUDY PURPOSE: To synthesize the evidence regarding the effect of rapid diagnostic approaches on anxiety in patients with cancer

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, PsycINFO, and Cochrane Collaboration
 
KEYWORDS: Neoplasm, anxiety, distress, stress, quality of life (QOL), and psychological
 
INCLUSION CRITERIA: Patients scheduled to undergo at least one invasive diagnostic procedure; suspicion of cancer; pre- and post-use of at least one validated measure for anxiety, QOL, or depression; follow-up within six weeks
 
EXCLUSION CRITERIA: Small pilot studies, abstracts, studies involving cancer screening, studies involving surgery, and editorials and letters

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,846
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No quality rating identified

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED: 23
  • TOTAL PATIENTS INCLUDED IN REVIEW: 3,663
  • SAMPLE RANGE ACROSS STUDIES: 27-583 patients
  • KEY SAMPLE CHARACTERISTICS: Most (16) studies involved patients with breast cancer.

Phase of Care and Clinical Applications

PHASE OF CARE: Diagnostic

Results

Patients receiving a benign diagnosis showed significant decreases in anxiety. Women eventually diagnosed with breast cancer had either increased or sustained anxiety levels; however, increases were not statistically significant in all but one study. Findings were mixed in this regard across studies involving prostate and ovarian cancer and melanoma. Among suspected breast cancer cases, 46%-73% had anxiety scores (Hospital Anxiety and Depression Scale [HADS] instrument) that were ≥ 8, indicating at least borderline clinically relevant anxiety. In studies using the State-Trait Anxiety Inventory (STAI) tool, suspected patients with breast cancer had mean STAI scores between 40.1 and 60, with a score of 44 being considered high anxiety. Three studies examined the effect of rapid diagnostic evaluation in breast cancer. One study found significantly larger reduction in anxiety after 24 hours in a one-stop evaluation versus two-stop evaluation; however, this difference disappeared after three weeks. In all studies, anxiety declined significantly among those who had benign result when results were obtained more quickly. In all studies, there were small numbers of patients who were diagnosed with benign disease.

Conclusions

Rapid diagnostic pathways reduce anxiety in patients with benign disease.

Limitations

No evaluation of the quality of studies was included.

Nursing Implications

Findings that anxiety declines in patients with benign disease are not surprising. Findings confirm that the more quickly one receives a benign diagnosis, the more quickly related anxiety is reduced. The emotional impact during the diagnostic phase related to cancer can be substantial. Use of one-stop rapid diagnosis can result in a shorter period of uncertainty and related anxiety.

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Brito, M., Esteves, S., Andre, R., Isidoro, M., & Moreira, A. (2016). Comparison of effectiveness of biosimilar filgrastim (Nivestim), reference Amgen filgrastim and pegfilgrastim in febrile neutropenia primary prevention in breast cancer patients treated with neo(adjuvant) TAC: A non-interventional cohort study. Supportive Care in Cancer, 24, 597–603. 

Study Purpose

To compare the effectiveness of a new biosimilar colony-stimulating factor (CSF) compared to reference CSF medications

Intervention Characteristics/Basic Study Process

Data were obtained from medical records in a tertiary cancer center for women with breast cancer who had received TAC chemotherapy. The febrile neutropenia management protocol was the same in all cohorts. Outcomes were compared across cohorts of patients who had received the biosimilar filgrastim, reference filgrastim, and pegfilgrastim.

Sample Characteristics

  • N = 420
  • MEDIAN AGE = 50 years 
  • AGE RANGE = 25–76 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All women had breast cancer.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Portugal

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Retrospective cohort comparison

Measurement Instruments/Methods

  • Febrile neutropenia (FN) defined at body temperature ≥ 38 C and ANC ≤ 500 cell/mcl
  • ANC
  • FN-related treatment delays, reductions, or terminations

Results

FN episode rates were 16%, 9%, and 16% in the reference filgrastim, pegfilgrastim, and biosimilar groups respectively. ANC at the time of FN diagnosis was lower in the biosimilar group in comparison with reference filgrastim (p = 0.015), and FN episodes were more frequent in the biosimilar group compared to both other groups (p ≤ 0.02). There were more chemotherapy delays in the biosimilar group compared with pegfilgrastim (p = 0.04). There were no other differences between groups.

Conclusions

Findings suggest the need for ongoing studies to determine comparative efficacy of this biosimilar CSF for prevention of febrile neutropenia and related complications in patients receiving cancer treatment.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • There were differences among cohorts in age, extent of disease, and use of antibiotic prophylaxis, which could have influenced results.

Nursing Implications

There are a growing number of biosimilar CSF agents being produced, and it is not yet clear if there are important clinical differences in bioavailability and activity in the clinical setting. Nurses should be aware of patients who are receiving biosimilar agents and monitor them for signs of FN or infection. Ongoing research is needed to determine safety and efficacy of these newer CSF agents over time.

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Brick, N. (2013). Laxatives or methylnaltrexone for the management of constipation in palliative care patients. Clinical Journal of Oncology Nursing, 17(1), 91–92. 

Purpose

STUDY PURPOSE: To assess the effectiveness of a laxative versus methylnaltrexone for the management of constipation in palliative care patients
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Cochrane Library of Systematic Reviews
 
KEYWORDS: Effectiveness of laxatives, methylnaltrexone 
 
INCLUSION CRITERIA: Randomized clinical trials required to have investigated effectiveness of laxatives or methylnaltrexone; published and unpublished studies; adults; cancer and other chronic diseases
 
EXCLUSION CRITERIA: None noted

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Seven randomized controlled trials (RCTs)
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Review of RCTs with data extraction; meta-analysis was used to provide a pooled estimate effect where the data were of sufficient quality

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 7
  • TOTAL PATIENTS INCLUDED IN REVIEW = 616
  • KEY SAMPLE CHARACTERISTICS: Average age = 61–72 years; patients in advanced stage of diseases in palliative care; four studies examined lactulose, senna, co-danthramer, misrakasneham, and magnesium hydroxide with liquid paraffin; three studies evaluated methylnaltrexone

Phase of Care and Clinical Applications

PHASE OF CARE: End of life care
 
APPLICATIONS: Palliative care

Results

All of the studies investigated variables in laxative types, opioid doses, and frequency of stools. Outcome measures included change in frequency of bowel movements, ease of defection, relief of systemic and abdominal symptoms of constipation, change in quality of life, and the use of rescue laxatives. There were no significant cross-findings, except all participants required rescue laxatives despite the initiation of a constipation prevention regimen. In two studies of (288) participants using methylnaltrexone versus a placebo, a statistically significant difference favored the intervention of rescue-free laxation 4 hours and 24 hours after the first dose of methylnaltrexone. Thirty percent of those participants experienced adverse effects. One study of 33 participants with methylnaltrexone showed a statistical difference favoring higher doses. Adverse effects were similar.

Conclusions

There were no recommendations for optimal laxative management of constipation in palliative care patients.

Limitations

There was little concrete evidence and too many variables across the studies. There was no information on how the search was conducted. It was very difficult to follow the evidence summary.

Nursing Implications

The effectiveness of laxatives and the optimum management of constipation in palliative care patients requires further investigation involving the measurement of standardized, clinically relevant outcomes in a clearly defined population.

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Breitbart, W., Rosenfeld, B., Pessin, H., Applebaum, A., Kulikowski, J., & Lichtenthal, W.G. (2015). Meaning-centered group psychotherapy: An effective intervention for improving psychological well-being in patients with advanced cancer. Journal of Clinical Oncology, 33, 749–754. 

Study Purpose

To test the efficacy of group psychotherapy to reduce distress and improve spiritual well being among patients with advanced or terminal cancer

Intervention Characteristics/Basic Study Process

Groups of 8-10 patients were formed and then randomized to either meaning-centered group psychotherapy (MCGP) or supportive group psychotherapy (SGP) as an active control. Questionnaires were completed at baseline, after eight weeks of therapy, and two months after completion of the intervention. MCGP focused on helping people develop or increase meaning. SGP focused on coping by encouraging patients to share concerns, describe experiences and emotions, and offer support and advice to each other. Groups met weekly, and all were facilitated by a social worker or clinical psychologist and doctoral student. Facilitators only conducted one type of session, clinical supervision was done weekly, and group sessions were audiotaped for random review for fidelity of the intervention

Sample Characteristics

  • N = 127
  • MEAN AGE = 58.3 years (range = 27 -91)
  • MALES: 30%, FEMALES: 70%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types.
  • OTHER KEY SAMPLE CHARACTERISTICS: Predominantly Caucasian ethnicity, but did include African Americans and Hispanics, overall average years of education was 15.9.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: New York

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

  • Randomized parallel group trial

Measurement Instruments/Methods

  • Functional Assessment of Chronic Illness Therapy Spiritual Well Being Scale
  • McGill QOL questionnaire
  • Beck Depression Inventory
  • Hospital Anxiety and Depression Scale
  • Hopelessness Assessment in Illness Questionnaire
  • Memorial Symptom Assessment Scale
  • Mini Mental State Exam
  • Functional Social Support Questionnaire

Results

Depression declined over time in all participants, but showed a significant decline among those in the meaning centered psychotherapy group, for those who completed at least three sessions (p < 0.05). The number of those completing three sessions is not provided.  All other measures, except anxiety, also improved over time and improved more in the meaning-centered group. Within group change scores showed moderate effects in both MCGP (d = 0.54) and SGP (d = 0.39).

Conclusions

Both types of group therapy used here were associated with improvement in depression and quality of life measures. Results were somewhat stronger for the meaning-centered therapy group.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement validity/reliability questionable
  • Subject withdrawals at 10% or greater 
  • Other limitations/explanation: There was no complete control group, and the active control intervention used here could also have positive effects on outcomes measured. Patients completed a battery of repeated measures which could have resulted in fatigue and testing effects. Only 65%-70% completed at least one session. Sample included those without clinically relevant depression or anxiety, so there was limited opportunity for improvement. Medications used that could have affected outcomes are not stated. Those in the MCGP had higher distress at baseline.

Nursing Implications

Group psychotherapy can be helpful to patients with advanced cancer for depression and quality-of-life issues, and both meaning-centered and supportive interventions may be of benefit. There are a number of study limitations here which mitigate the strength of these findings. Nurses can consider and advocate for these types of interventions for appropriate patients.

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Bredlau, A.L., Thakur, R., Korones, D.N., & Dworkin, R.H. (2013). Ketamine for pain in adults and children with cancer: A systematic review and synthesis of the literature. Pain Medicine, 14, 1505–1517. 

Purpose

STUDY PURPOSE: To synthesize data on ketamine for refractory cancer pain in adults and children
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE and PubMed
 
KEYWORDS: Ketamine, cancer pain, and related medical subject heading terms 
 
INCLUSION CRITERIA: Peer-reviewed publications, use of ketamine for refractory pain, any research design and case series including more than 10 patients
 
EXCLUSION CRITERIA: Ketamine use for procedural pain

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 179

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 13 (in adults), 5 (in children)
  • TOTAL PATIENTS INCLUDED IN REVIEW: 483 adults
  • SAMPLE RANGE ACROSS STUDIES: 9–181 patients
  • KEY SAMPLE CHARACTERISTICS: All had refractory pain.

Phase of Care and Clinical Applications

PHASE OF CARE: End-of-life care
 
APPLICATIONS: Palliative care

Results

There were five double-blind, randomized, controlled trials, six uncontrolled trials, and one case series in adults. These showed descreases in pain ratings with oral, subcutaneous, sublingual, and IV ketamine. Reduced pain was shown in 50%–90% of participants. Dosages varied greatly across studies. Common side effects were sedation, somnolence, sensory illusions, dissociative feelings, blurred vision, anorexia, abdominal pain, insobriety, and dream disturbances. At higher doses delirium, impaired motor function, amnesia, panic attacks, mania, insomnia, and elevated blood pressure have been reported. Studies in children involved 16 patients treated with IV ketamine.

Conclusions

In adults with chronic pain that is not controlled with opioids, ketamine appears to decrease opioid use and improve pain control. There is insufficient evidence to form any conclusions regarding its use in children.

Limitations

Few studies, most of which had small samples, particularly among children

Nursing Implications

Ketamine may be promising for the management of refractory pain that is poorly responsive to opioids; however, its use is associated with a variety of side effects. In most cases for chronic pain, ketamine has been studied in patients with very limited life expectancies. There is very little evidence in children. Further research is needed to fully establish ketamine's usefulness for pain control. If ketamine is used, nurses need to be aware of potential side effects and should monitor patients for them. There is no current evidence to show that ketamine is superior to other therapies for pain.

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Bredin, M., Corner, J., Krishnasamy, M., Plant, H., Bailey, C., & A’Hern, R. (1999). Multicentre randomised controlled trial of nursing intervention for breathlessness in patients with lung cancer. BMJ, 318(7188), 901–904.

Intervention Characteristics/Basic Study Process

Patients diagnosed with lung cancer were randomized to attend a nursing clinic offering interventions for breathlessness versus best supportive care. The intervention consisted of

  • A detailed assessment of breathlessness, what hinders it, and what aids it
  • Advice and support for patients and families on management of breathlessness
  • Exploration of the meaning of breathlessness, disease, and their future
  • Training in breathing control techniques, relaxation techniques, and distraction exercises
  • Goal setting to complement breathing and relaxation techniques, to improve function and social activities, and to help develop coping skills
  • Early identification of problems needing pharmacologic or medical intervention
  • Clinic visits once a week up to eight weeks and not less than three weeks.

Control: received standard of care for breathlessness; best supportive care involved standard management and treatment available for dyspnea. Nurse specialists used and were taught the intervention in same way, using a practice guideline to ensure correct delivery of the intervention.

Sample Characteristics

The study reported on a sample of 119 patients with lung cancer; the goal was to recruit 150 patients for 90% power. Data from 16 patients were lost because a center was dropped from the study. Final sample included 51 in the intervention group and 52 in the control group.

Setting

The study was conducted in nursing clinics in six hospital settings in London, United Kingdom.

Study Design

The study design included randomization to either intervention or control group.

Measurement Instruments/Methods

Outcome measures were conducted at baseline and at four and eight weeks.

  • VAS measuring breathlessness at worst and at best and distress caused by breathlessness
  • World Health Organization (WHO) performance status scale
  • HAD
  • Rotterdam symptom checklist

Results

The intervention group improved significantly at eight weeks in 5 of 11 items assessed.

  • Breathlessness at best
  • WHO performance status
  • Level of depression
  • Physical symptom distress and breathlessness from Rotterdam symptom checklist

Final sample included 51 in the intervention group and 52 in the control group. Attrition: 16 patients died, and 28 withdrew. Reasons for withdrawal: 1 improved condition, 16 had deterioration, 4 were unhappy with the assigned treatment arm, and 7 were for unknown reasons. Survival of patients who withdrew was significantly worse than the intervention arm (hazard ratio = 2.5; p < 0.05). Survival of all who withdrew versus nonwithdrawals was also significantly worse (p < 0.01). Overall survival of the intervention and control groups was not different. At baseline, both groups had high level of distress caused by breathlessness and associated functional impairment.

Conclusions

Overall conclusion is that patients attending nursing clinics for breathlessness experienced improvements in breathlessness, performance status, and physical and emotional status.

Limitations

The analysis was based on the assumption that missing data from patients who withdrew because of poor outcomes were assigned a lower change score .The findings would have been more credible if outcomes were actually assessed. The method assumed that patients were able to show a change in either direction on rating scales, but patients who were on the extreme could only go in one direction. As stated in the Corner et al. (1996) pilot study, the contribution of each component of the intervention is unknown. Are all components needed to achieve the same outcome, or was one aspect of the intervention most significant?

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Schou Bredal, I., Karesen, R., Smeby, N.A., Espe, R., Sorensen, E.M., Amundsen, M., . . . Ekeberg, O. (2014). Effects of a psychoeducational versus a support group intervention in patients with early-stage breast cancer: Results of a randomized controlled trial. Cancer Nursing, 37, 198–207. 

Study Purpose

To investigate which approach, psychoeducation or support, provides the greatest benefit to patients with early-stage breast cancer

Intervention Characteristics/Basic Study Process

Women who had undergone surgery for breast cancer were randomly assigned to receive either a support group (SG) or psychoeducational group (PEG). The PEG intervention consisted of health education about breast cancer and side effects of treatments, stress management (including training and a DVR in progressive muscle relaxation), enhancing problem solving skills, and psychological support from research staff and other group members. Sessions were two hours weekly for five weeks. The SG intervention was part of routine care, consisted of three weekly two-hour sessions on topics women introduced for discussion. A surgeon, physical therapist, and a breast cancer survivor attended the group for 30 minutes each to provide information in a question and answer format. Study assessments were done at baseline, at 2 months, 6 months, and 12 months.

Sample Characteristics

  • N = 367  
  • MEAN AGE = 54.75 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer.  Most were stage T1 or T2.  More than 70% had radiotherapy, 50% had chemotherapy, and 60% had endocrine therapy. All had surgery.
  • OTHER KEY SAMPLE CHARACTERISTICS: 67% were married, 38% were employed, and slightly more than 50% had more than a high school education.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient    
  • LOCATION: Norway

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  • Randomized, controlled trial with active control

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale
  • Mini Mental Adjustment to Cancer scale
  • Life Orientation Test, revised (measuring optimism and pessimism)

Results

Ninety-seven percent of patients attended all sessions in both groups. Both groups showed significant decline in anxiety. With adjustment for baseline anxiety level, there were no differences in anxiety levels between groups after the intervention. Depression declined significantly in all patients over time, with no difference between groups. At various time points, there were differences in mental adjustment to cancer between optimists and pessimists, but these differences were not consistent, and there were no significant differences at 12 months. Within the first six months, there was greater decline in anxiety and depression among those in the PEG group.

Conclusions

Women in both groups showed reduced anxiety and depression over time. There were no differences in results between those receiving a support group versus a psychoeducational intervention except in the first 6 months. Psychoeducation may be more helpful in the short term at a time when patients are likely to have more distress.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Other limitations/explanation: Unclear if repeated measures could have created a testing effect. Content in both groups was similar, raising the question of whether these two interventions were substantially different from each other. Groups received a different number of sessions, which could have accounted for the few differences seen. 

Nursing Implications

Findings suggest that both psychoeducational and support group interventions can be beneficial to women dealing with breast cancer. In the short term, findings suggest that psychoeducation may yield some greater benefits, but there were no long-term differences based on the type of intervention provided. It may be beneficial to incorporate more psychoeducational components into routine support group and supportive interventions.

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Brayton, K.M., Hirsch, A.T., O'Brien, P.J., Cheville, A., Karaca-Mandic, P., & Rockson, S.G. (2014). Lymphedema prevalence and treatment benefits in cancer: Impact of a therapeutic intervention on health outcomes and costs. PLOS One, 9, e114597. 

Study Purpose

To examine the insurance data of cancer survivors to determine lymphedema prevalence and to assess the affect on specific clinical health outcomes and healthcare costs after the receipt of a pneumatic compression device (PCD) among the identified study group of cancer survivors with lymphedema

Intervention Characteristics/Basic Study Process

The researchers performed a retrospective analysis of health claims data from 2007–2013. D-identified administrative health claims data from deidentified Normative Health Information (dNHI) database (34 million insured) were used through OptumInsight. Researchers did not have access to the data but rather instructed Optum employees to cull the data.  

  • ICD-9 codes were used to select patients with cancer.
  • ICD-9 codes for lymphedema (457.0, 457.1, and 757.0) were sought among the patients with cancer.  
  • The Healthcare Common Procedure Coding System (HCPCS) codes for a PCD, E0651, or E0652 were searched among patients with cancer and lymphedema.
  • Every participant was required to have had 12 months of insurance coverage prior to the receipt of a PCD, which then carried through another 12 months.  
  • Any patients who received a replacement pump were excluded.

Sample Characteristics

  • N = 1,065   
  • AGE = 9.2% aged 19–44 years, 53.2% aged 45–64 years, and 37.6% aged 65 years or older
  • MALES: 20%, FEMALES: 80%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Patients with cancer with insurance for 12 months prior to and after the receipt of a PCD (index date). Baseline period was 12 months prior to receipt of the pump. Follow-up was 12 months after receipt of the pump.  
  • OTHER KEY SAMPLE CHARACTERISTICS: Nineteen percent were obese.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: USA

Study Design

A retrospective study of insurance data from 2007–2013. The researchers compared the rate of identified clinical healthcare outcomes and their costs in each setting for the year prior to the receipt of a PCD to the rates and costs after receipt of the PCD.

Measurement Instruments/Methods

After the sample was identified, the affect of the receipt of the PCD was determined by searching for specific claims codes and their costs during the 12 months before and after receipt of the PCD. Specific health outcomes, such as hospitalization, outpatient visits, physical therapy, episodes of cellulitis, and courses of lymphedema physical therapy, were determined by the American Medical Association place of service codes, and the clinical costs were designated as lymphedema related if the primary or secondary diagnoses were ICD-9: 457.0, 457.1, 757.0. Total cost was the sum of the payments for lymphedema claims. Continuous variables were tested pre PCD minus post PCD with a paired t test.

Results

  • Prevalence: In 2007, a prevalence of lymphedema cancer survivors existed at 0.95% in the database. The prevalence rose to 1.243% in 2013.
  • Health outcomes: While receipt of a PCD appeared to have no affect on the rate of hospitalizations for patients with lymphedema, it did appear to reduce the percentage of patients attending outpatient hospital visits (p < 0.0001) and the percentage of patients using physical therapy (p < 0.0001). In addition, the number of patients diagnosed with cellulitis decreased significantly (p < 0.0001).  
  • Healthcare Costs: The total healthcare cost for patients with cancer-related lymphedema during the baseline year was $62,190 with inpatient costs accounting for $15,458, outpatient costs accounting for $21,222, and office visits accounting for $15,278. However, lymphedema-attributed costs were only 4% of the total, or $2,243. A significant decrease in total cost by 18% occurred in the 12-month period after receipt of the PCD (from $62,190 to $50,857) (p < 0.0001).

Conclusions

  • A study of the sample database showed an increasing prevalence of cancer-related lymphedema.
  • The healthcare outcomes data showed a reduction in the rate of hospitalizations, outpatient visits, physical therapy, and cellulitis as well as a significant healthcare cost reduction the year following the receipt of a PCD.

Limitations

  • Risk of bias (no control group)
  • Findings not generalizable
  • The stages of cancer are not known or accounted for, and some of the costs may reflect the burden of cancer care. 
  • The burden of disease is greater at the onset of lymphedema than when the limb swelling stabilizes. Likewise, the reduction of physical therapy reflects perhaps that the patients had physical therapy and then received a PCD for maintenance. Having a pump does not necessarily mean patients use the pump.
  • It is unknown if the patients received a compression garment. 
  • Other codes could have been looked at, including 97140, manual lymph drainage. 
  • Too many confounding variables exist, making the results nongeneralizable. 
  • As the authors pointed out, inaccuracy in coding cannot be ruled out. The low obesity/overweight rate of 19% was below the national average, which is currently 68.8%.

Nursing Implications

Lymphedema prevalence among cancer survivors continues to be defined. Whether a PCD improved healthcare outcomes or reduced healthcare costs is unclear. Nevertheless, healthcare outcomes and costs were reduced. A PCD may benefit outcomes and reduce costs. Even with the limitations of this study, lymphedema needs to be diagnosed, treated early, and managed to reduce the disease burden.

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Branstrom, R., Kvillemo, P., & Moskowitz, J.T. (2012). A randomized study of the effects of mindfulness training on psychological well-being and symptoms of stress in patients treated for cancer at 6-month follow-up. International Journal of Behavioral Medicine, 19, 535–542. 

Study Purpose

To report the six-month follow-up effects of a mindfulness stress reduction training program on perceived stress, depression, anxiety, post-traumatic stress symptoms, positive states of mind coping, self-efficacy, and mindfulness among patients treated for cancer

Intervention Characteristics/Basic Study Process

Patients with a previous cancer diagnosis were recruited and randomized into an intervention group or a waiting list control group. Questionnaires were sent to participants directly by mail after randomization at three and six months. The waiting list participants were scheduled to participate in the intervention program after six months. The intervention involved eight-week, two-hour, weekly sessions of mindfulness training. The sessions consisted of experiential and group exercises. The training was an adaptation of the Jon Kabat-Zinn program of mindfulness-based stress reduction (MBSR) from the Stress Reduction and Relaxation Clinic at the Massachusetts Medical center in Shrewsbury. For details of the program, the authors refer to a previous publication.

Sample Characteristics

  • N = 71  
  • MEAN AGE = 51.8 years (SD = 30–65 years)
  • MALES: 1, FEMALES: 70
  • KEY DISEASE CHARACTERISTICS: Study was open to patients with varying cancer diagnoses who were not undergoing current radiation or chemotherapy treatment. Fifty-four patients had been treated for breast cancer, 10 for gynecological cancer, five for lymphatic cancer, one for pancreatic cancer, and one for neck cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Ten patients were diagnosed within the last year, 39 within one to two years, and 22 more than two years ago. Thirty-nine patients had a bachelor’s degree and 30 had full- or part-time employment. Twenty-three participants used antidepressants.

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Outpatient    
  • LOCATION: Stockhom, Sweden

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Elder care

Study Design

Randomized, controlled intervention and wait-list groups; random selection of participants was done consecutively using a random sequence of numbers indicating group assignment

Measurement Instruments/Methods

  • The SPSS software’s random selection was used for the sequence of numbers.
  • Power calculations were conducted to decide the adequate number of participants.
  • Perceived Stress Scale (PSS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Impact of Event Scale Revised (IES-R)
  • Positive States of Minds (PSOM)
  • Coping Self-Efficacy Scale (CSES)
  • Five-Facet Mindfulness Questionnaire (FFMQ)
  • Meditation practice: The frequency of meditation practice before and during the study period was assessed with one question.  
  • The intervention effect was analyzed using multivariate repeated measure analysis of covariance (MANCOVA).

Results

Compared to participants in the control group, the intervention group showed a larger increase in mindfulness at the six-month follow-up. There were no differences in any other outcomes between the intervention and control groups. 60% of the participants reported regular meditation practice during the intervention period. Continued meditation practice was associated with a significant reduction in post-traumatic stress symptoms of avoidance. Change in psychological distress, positive states of mind, and coping self-efficacy did not show any significant differences between the control and intervention group. There were trends in a greater reduction of perceived stress. There was a significant change in the intervention group reporting increases in mindfulness. Postintervention, 38% of the participants in the intervention group continued to meditate regularly. Those in the intervention group who continued to mediate regularly after the intervention had a significant reduction in post-traumatic avoidance symptoms at the six-month follow-up (t = 2.5, p < .5). No other significant intervention effects on psychological outcomes were found.

Conclusions

The study indicates the need to better understand the mechanism behind the effects of MBSR and the potential modification of mindfulness interventions to promote a sustained benefit over time. Future studies should examine the potential of additional intervention tools to encourage postintervention meditation practice. The short-term positive effects of mindfulness training and the particular time when mindfulness intervention might have the most positive effects should be further studied.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Many measurement tools

 

Nursing Implications

The lack of sustained, positive effects from mindfulness training suggests that booster sessions or tools for increasing postintervention adherence to mindfulness practice would be beneficial. Assisting patients in integrating mindfulness training into everyday life would benefit patients as the increased dispositional level of mindfulness moderates the influence of stress on both depression and perceived health.

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