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Hwang, J.M., Hwang, J.H., Kim, T.W., Lee, S.Y., Chang, H.J., & Chu, I.H. (2013). Long-term effects of complex decongestive therapy in breast cancer patients with arm lymphedema after axillary dissection. Annals of Rehabilitation Medicine, 37, 690–697. 

Study Purpose

To investigate complex decongestive therapy (CDT) and its long-term effects on reduction of edema in patients with breast cancer-related lymphedema who have undergone axillary lymph node dissection, based on their initial fluid volume

Intervention Characteristics/Basic Study Process

A retrospective review of 57 patients was done. Patients were treated with CDT for two weeks and followed for 24 months, with arm volumes being measured before/immediately after CDT, and at 3, 6, 12, and 24 months. Patients were divided into two groups according to their percent excess volume (PEV).

Sample Characteristics

  • N = 57  
  • AGE = 48.6 (SD = 10.3)
  • MALES: 2%, FEMALES: 98%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: Right-arm lymphedema in 23 patients; left-arm lymphedema in 34 patients.

Setting

LOCATION: Seoul, Korea

Study Design

  • Retrospective review of patients

Measurement Instruments/Methods

  • Independent T-test,
  • Linear mixed model 
  • SPSS®, version 18.0

Results

Group 1 had a mean PEV of 11.4% (SD = 5) before CDT and 14.1% (SD = 10.6) at 24 months after CDT, with no significant difference. Group 2, which had a higher initial PEV of 41.9% (SD = 19.6) showed a significant reduction at 24 months to 28.8% (SD = 15.7).

Conclusions

Patients with a higher initial PEV showed a greater reduction in fluid volume after using CDT. For patients with a lower initial PEV, their lymphedema did not increase in severity.

Limitations

  • Small sample (< 100)

Nursing Implications

Nurses should encourage movement of affected arms to promote lymphatic drainage, especially in patients with a higher PEV.

Print

Hwang, K.H., Jeong, H.J., Kim, G.C., & Sim, Y.J. (2013). Clinical effectiveness of complex decongestive physiotherapy for malignant lymphedema: A pilot study. Annals of Rehabilitation Medicine, 37, 396–402. 

Study Purpose

To evaluate the effect of complex decongestive physiotherapy on patients with malignant lymphedema, with regard to volume reduction and quality of life (QOL)

Intervention Characteristics/Basic Study Process

There is no comparison/control group. Patients received non-elastic compression therapy, remedial exercise, and skin care.  Manual lymphatic drainage (MLD) was not utilized.

Sample Characteristics

  • N = 22  
  • AGE = 35–80 years (Mean = 60)
  • MALES: 5%         FEMALES: 17%
  • KEY DISEASE CHARACTERISTICS: Cancer survivors diagnosed with malignant lymphedema; selected by one physician in the Department of Rehabilitation at Kosin University Hosptial in Korea.
  • OTHER KEY SAMPLE CHARACTERISTICS: Greater than 2 cm circumference difference between affected upper or lower limb and the ‘normal’ upper or lower limb; diagnosis of lymphedema by lymphoscintigraphy; lymphatic channel or lymph node invasion in axilla, pelvis, lumbar, or inguinalareas diagnosed by imaging; aggressive, or rapidly progressing limb swelling
  • EXCLUSION CRITERIA: Age greater than 80 years, bilateral lymphedema of upper or lower limbs, patients with benign lymphedema before malignant metastasis, patients with induced lymphedema during radiotherapy or chemotherapy, vascular disorders that might cause lymphedema and poor communication skills or low treatment compliance

Setting

  • SITE:  Single site  
  • SETTING TYPE:  Inpatient  
  • LOCATION: Kosin University Hospital, Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Pilot study

 

Measurement Instruments/Methods

  • Changes in limb volume via circumferential limb volume measurements
  • Pain intensity via 10-point Visual Analog Scale (VAS)
  • QOL via Short form-36, version 2, questionnaire (SF-36)

Results

The authors report a statistically significant difference in volume change in upper limbs (p = 0.001) and lower limbs (p = 0.001).

Conclusions

Components of complex decongestive physiotherapy (CDPT) are helpful in treating malignant lymphedema for pain and volume reduction, with positive impact on QOL. MLD was not utilized, based on conflicting reports regarding potential for spreading cancer. However, the authors state all components of the CDPT program, except MLD, are helpful when MLD was not utilized or controlled.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Selective outcomes reporting 

Nursing Implications

CDPT has a positive effect on QOL and limb volume reduction. This particular study did not utilize MLD, one of the main components of CDT. The reason given was that MLD could potentially spread cancer via the lymphatic channels; however, in fact, malignant lymphedema is a metastatic disease process.

Print

Hutchison, S.D., Sargeant, H., Morris, B.A., Hawkes, A.L., Clutton, S., & Chambers, S.K. (2011). A community-based approach to cancer counselling for patients and carers: A preliminary study. Psycho-Oncology, 20, 897–901.

Study Purpose

To provide guidance for cancer services by describing intervention strategies, characteristics, psychological concerns, and distress outcomes for patients and their carers that use a community-based cancer counseling service

Intervention Characteristics/Basic Study Process

Clients who accessed a statewide cancer telephone helpline received referral to a free community-based and evidence-based multicomponent cancer counseling service (CCS) that provided brief telephone-delivered psychosocial interventions for individuals struggling to cope with cancer. CCS clients were referred from a statewide cancer helpline that provides individual support and information about cancer. Over a three-year period, 86% of the 1,201 people who received CCS services met the inclusion criteria for the institutional review board–approved study. Qualified psychologists spoke to patients and carers on the phone. Outcomes measures included the Stress Distress Thermometer and a session satisfaction questionnaire. Collection of measures occurred via each telephone interaction between the psychologist and patient or carer upon client referral to CCS and at each counseling session.

Criteria for referral to the CCS included high levels of self-reported cancer-related distress and/or request for counseling. The CCS interventions are multicomponent and include psychoeducational, emotional support, coping skills, cognitive behavior therapy, and other psychological interventions such as mindfulness, acceptance and commitment therapy, communication skills, and partner support. Interventions are short-term, with clients generally receiving five sessions.

Sample Characteristics

  • The sample was comprised of 681 patients with cancer and 520 carers.  
  • Patient mean age was 52.8 years (SD = 11.8; range = 18–84 years); carer mean age was 49.7 years (SD = 13.5; range = 18–86 years).
  • The male sample was 23.3% patient and 12.5% carer; the female sample was 76.7% patient and 87.5% carer.
  • Patients had breast cancer (35.8%), lung cancer (12.5%), bowel cancer (11.3%), prostate cancer (8.5%), hematologic cancer (6.7%), brain cancer (5.6%), melanoma (5.6%), and other cancers (32.9%). 
  • Of the carers, 94% were patient partners or immediate family members.
  • The majority (88%) of patients and carers had an English-speaking background and did not represent ethnically diverse population groups.
  • Approximately 75% of patients and carers had finished secondary or tertiary schooling.
  • More than half of patients were not working, whereas 25.4% of carers worked full-time.
  • More than half (56.7%) of patients had a diagnosis of cancer for six months or less.
  • The number of rural and urban patients and carers was approximately equal.

Setting

  • Multisite
  • Home setting 
  • Queensland, Australia

Phase of Care and Clinical Applications

  • Active treatment
  • First diagnosis; cancer diagnosis and treatment continuum; telephone intervention

Study Design

A repeated measures design was used.

Measurement Instruments/Methods

  • Distress Thermometer: This instrument measured patient and carer distress during the past week. Data were collected at referral and at the beginning of each telephone session. No identified reliability or validity indices were provided.
  • Session satisfaction: Patients and carers provided a single rating of their overall satisfaction with the telephone session. Data were collected at referral and at each counseling session. No identified reliability or validity indices were provided.

Results

There were significant differences (p < 0.001) between patients and carers who identified concerns before the telephone intervention. However, both groups identified adjusting to cancer as the most common presenting problem. Other predominant problems for patients were anxiety, depression, and family relationships. Predominant problems for carers were bereavement, anticipatory grief, and family/intimate relationships. There was no significant difference in the number of telephone sessions for patients and carers. Eighty-six percent completed therapy in five sessions. A t test indicated that the average length of sessions significantly differed for patients and carers (t [4193] = 2.43, p < 0.05). Carers had significantly (p < 0.001) more distress before the telephone intervention and postintervention than patients, although both groups showed a significant decrease in distress by the final intervention (p < 0.001). Almost 70% of patients and carers met “improvement” or “recovery” on the Distress Thermometer assessment postintervention. No significant distress differences were noted between patients and carers referred to further counseling postintervention than those who did not complete therapy. Mean satisfaction ratings for sessions were 9.35 based on a possible 10-point (“just right”) scale.

Conclusions

This study demonstrated the effectiveness of a CCS telephone-delivered intervention to patients with cancer and many of their carers for a wide range of identified problems over the cancer trajectory. The delivery format allows provision of educational and emotional support to both groups despite place of residence, ability to leave the home, and other factors affecting access to the intervention.

Limitations

  • The study did not have a comparison or control group.
  • The study had no randomization to intervention data collection by individuals providing the support sessions immediately before and after each session.
  • The study used brief assessment measures with lack of psychometric data: The study did not isolate whether the CCS  telephone intervention is more effective at certain times of the cancer trajectory or ways standardization of the intervention occurred that would better support outcomes measures. It appears that the patient and carer separately received the intervention, a process that might prevent needed dialogue between the patient and carer on an urgent issue needing their collaboration. It is not clear how psychologists who provided the intervention were trained or how monitoring occurred to ensure intervention integrity. One may question the freedom of the patient or carer to deliver a true oral evaluation of a counseling session over the phone when that psychologist may render future services.

Nursing Implications

Nurses providing oncology care must carefully screen both patients and carers for concerns during the cancer treatment cycle. This screening may need to occur with each individual patient and carer alone to gain accurate information that is useful for individualized teaching and support. Nurse–patient/carer telephone dialogues between clinic or hospital visits may also be valuable in preventing and treating concerns before they become urgent issues needing attention. Healthcare team referral to social workers, spiritual leaders, and others specific to patient or carer concerns may also prove valuable to prevent or treat carer or patient depression or anxiety that affects the ability of the dyad to effectively cope with the cancer experience. Future research also is needed to investigate the effect of the intervention on low literacy and ethnically diverse people with cancer who value a face-to-face encounter as essential to their perception of health provider support during cancer care. 

Print

Husson, O., Mols, F., & van de Poll-Franse, L.V. (2011). The relation between information provision and health-related quality of life, anxiety and depression among cancer survivors: A systematic review. Annals of Oncology: Official Journal of the European Society for Medical Oncology/ESMO, 22(4), 761–772.

Purpose

To complete a systematic review of available literature regarding the relationship between information provision and health-related quality of life, anxiety, and depression

Search Strategy

  • Databases searched were PubMed and PsycINFO. The search was for original articles published up to February 2010.
  • Search keywords were cancer, information, information provision, information disclosure, information needs, information satisfaction, information level, information barriers, written information, oral information, audiotape information, CDROM, quality of life, health status, well-being, anxiety, depression.
  • A study was included if it was appropriate to the purposes of the analysis, was the original article, was printed in the English language, and was published in a peer-reviewed journal.
  • A study was excluded if it was a care report or a review article, was related to end-stage cancer patients, focused on communication aspects, focused on family members, focused on diagnosis or prognosis, or used a single-item measure of health-related quality of life.

 

Literature Evaluated

  • The initial search found 5,732 articles. In reviewing the abstracts, 37 articles potentially met the study criteria.
  • The study consisted of (1) design: prospective, cross-sectional, (2) study population: size, diagnosis, stage, (3) measuring instruments, (4) types of information provision instruments, (5) results, and (6) overall methodological quality based on a scoring system. The evaluation criteria for methodological quality included the validity of measurements, clearly stated inclusion and exclusion criteria, the inclusion of sociodemographic variables, participation or response rates higher than 75%, sample size, a prospective study design, comparisons of results to other groups or times, and sound data analysis.
  • Other comments on literature evaluated: Investigators did not conduct meta-analysis.
     

Sample Characteristics

  • The final number of studies included in the sample was 25. All the studies had been conducted from 1996 through 2009. After detailed evaluation, three investigators selected 25 of the 37 articles.
  • Sample size across the studies was 30–3,197.
  • Participants were cancer survivors with diverse cancer types at various stages.

Phase of Care and Clinical Applications

  • Phase of care: long-term follow-up
  • Clinical applications: late effects and survivorship

Results

  • No part of the study was evaluated as being of low quality.
  • Prospective studies showed that satisfied patients—that is, patients who reported to receive large amounts of clear information—reported better mental health-related quality of life (HRQoL) and global health-related quality of life. Cross-sectional studies found a positive relation between HRQoL and fulfilled information needs, information satisfaction, information quality or clarity, and fewer information barriers. 
  • Cross-sectional and prospective studies reported that patients with information satisfaction in general had less anxiety and depression.
  • Of eight intervention studies that aimed to improve information provision, only one showed a positive association with better HRQoL. No benefit was found regarding depression or anxiety. Types of interventions and measured construct varied across the studies, making interstudy comparisons difficult. A lack of effect may be associated with the limited surplus value of the additional information given in the experimental conditions, the neutral mode of information provision without patients' active participation, the short duration of some of the interventions, and low compliance.

Nursing Implications

Additional research is needed before making definitive conclusions about information interventions is justified; because of methodological constraints, the results in the studies examined did not reach statistical significance. The fast and recent development of the field of patient-reported outcomes in cancer survivorship will make conducting studies of better quality possible.

Print

Husebo, A.M., Dyrstad, S.M., Mjaaland, I., Soreide, J.A., & Bru, E. (2014). Effects of scheduled exercise on cancer-related fatigue in women with early breast cancer. The Scientific World Journal, 2014, 271828. 

Study Purpose

To compare the effects of a scheduled, home-based exercise intervention to the effects of advising patients to exercise on fatigue, physical fitness, and physical activity level

Intervention Characteristics/Basic Study Process

Patients who had surgical treatment and were receiving adjuvant chemotherapy for breast cancer were randomly assigned to the scheduled exercise or control comparison groups. The intervention combined resistance and aerobic exercise with resistance bands and strength training three times per week along with 30 minutes of brisk walking daily. Those in the experimental group received motivational phone calls every two weeks. Patients in the control group were advised to continue their regular activity levels and had one follow-up phone call. Study measures were obtained at baseline, prior to chemotherapy, 8–24 weeks at the end of chemotherapy, and about six months after completing chemotherapy.

Sample Characteristics

  • N = 54
  • MEAN AGE = 52.2 years (SD = 9.3 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: 88.4% of patients had stage I or II disease; 80.6% had college-level education;  81% were living with a partner, and about one half were employed full or part-time.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Randomized controlled trial (RCT)

Measurement Instruments/Methods

  • Schwartz Cancer Fatigue Scale (SCFS-6)
  • International Physical Activity Questionnaire (IPAQ)
  • Six-Minute Walk Test (6MWT)
  • Exercise diary

Results

Fatigue scores increased significantly from baseline to the end of chemotherapy for all patients (p = .003) with no difference between groups. Fatigue returned to baseline levels after the end of chemotherapy with no difference between groups. A similar pattern was shown for all patients in physical fitness. There were no differences between groups in mean levels of physical activity per week, though there was a slight trend toward more exercise in the intervention group.

Conclusions

There were no additional effects of a scheduled home exercise program to reduce fatigue compared to individuals who were simply encouraged to maintain appropriate exercise levels.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Subject withdrawals ≥ 10%

Nursing Implications

Study findings show a pattern of fatigue such that fatigue increases significantly during chemotherapy and then declines after the end of treatment. Both groups of patients in this study performed exercise at general recommended levels, which likely accounts for the lack of differences in fatigue found. These results suggest that patients do not necessarily need to have scheduled approaches to exercise, and that encouraging patients to maintain at least moderate exercise levels can be effective. Nurses can encourage patients to maintain exercise and choose approaches that they prefer in order to maintain motivation for regular activity.

Print

Hurlow, A., Bennett, M.I., Robb, K.A., Johnson, M.I., Simpson, K.H., & Oxberry, S.G. (2012). Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database of Systematic Reviews, 3, CD006276.

Purpose

To review and summarize the evidence regarding the effect of transcutaneous electric nerve stimulation (TENS) for management of cancer-related pain

The type of study is systematic review.

Search Strategy

Databases searched were MEDLINE, CINAHL, PEDro, AMED, EMBASE, PsycINFO, and the Cochrane Central Register of Controlled Trials.

An extensive listing of search terms per database are provided.

Studies were included in the review if they evaluated TENS-administered monophasic or biphasic pulsed electrical currents, reported on participants 18 years or older, and were randomized controlled trials (RCTs) not involving active treatment control.

Studies reporting on percutaneous interventions were excluded.

Literature Evaluated

The total of four references were retrieved.

The Jadad scale was used for evaluation as well as the Cochrane risk of bias tool.

Sample Characteristics

Three studies were included in the review; two studies were added to prior review of two studies.

Sample range across studies was 15–49, with a total of 68 patients included in the review.

Results

Results were inconclusive due to lack of suitable RCTs for inclusion. One study indicated that bone pain may improve with TENS, but this was not well designed and underpowered. Two studies showed no significant difference with TENS.

Conclusions

No conclusions regarding the effectiveness of TENS can be made.

Limitations

  • The review included few studies with variable quality.
  • Studies were underpowered.

Nursing Implications

There is insufficient evidence to determine whether TENS is effective for management of pain in patients with cancer.

Print

Hunter, M. S., Coventry, S., Hamed, H., Fentiman, I., & Grunfeld, E. A. (2009). Evaluation of a group cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psycho-Oncology, 18, 560–563.

Study Purpose

To evaluate a group cognitive-behavioral intervention to alleviate menopausal symptoms (hot flushes [HF] and/or night sweats [NS]) in women who have had treatment for breast cancer.

Intervention Characteristics/Basic Study Process

Following a two-week daily diary assessment, patients were offered six 90-minute weekly sessions of group cognitive-behavioral therapy (CBT). CBT included:  information and discussion about menopausal symptoms; monitoring and modifying stimulants that precipitate symptoms; relaxation and paced breathing; and techniques to reduce stress and manage HF, NS, and sleep. The primary outcome measures were HF frequency and HF problem rating. Secondary outcomes included scores on the Women’s Health Questionnaire (WHQ) and scores pertaining to health-related quality of life (HRQOL) as measured by the SF-36®. Beliefs about HF were monitored to examine the effects of CBT. 

Sample Characteristics

  • The study was comprised of 17 women receiving group CBT.
  • Mean age was 53.7 years (range 46–65).
  • Of the patients, 12 (71%) had undergone breast-conserving surgery; 3 (18%), modified radical mastectomy; 9 (53%), chemotherapy; 14 (82%), radiotherapy; and 12 (71%) were taking adjuvant hormonal therapies (11 were taking tamoxifen; 1 was taking anastrozole).
  • At diagnosis, seven patients (41%) were premenopausal, six (35%) were in the early or late transition stage of menopause, and four (24%) were in the early or late postmenopausal stage.
  • Average time since diagnosis was 23.2 months.
  • Average duration of HF and NS was 2.1 years.
  • Patients were treated in groups (of six, six, and five members); 12 women (59%) attended all six sessions, three women attended five sessions, and two attended three sessions. The majority (83%) completed all assessments.

Setting

  • Multisite
  • Outpatient
  • Clinic staff recruited patients by using a database at two breast units in London, England.

Phase of Care and Clinical Applications

  • Patients were undergoing the transition phase of care:  after initial treatment and completion of chemotherapy and/or radiotherapy and with or without hormone replacement therapy.
  • The study has clinical applicability for late effects and survivorship.

Study Design

The study was a single-group, exploratory trial with pre- and posttreatment assessment after six weeks and three months.

Measurement Instruments/Methods

  • Hot Flush Frequency and Problem Rating Scale (HFRS) 
  • WHQ
  • Hot Flush Beliefs Scale (HFBS)
  • SF-36® HRQOL ratings
  • Daily diaries
     

Results

  • Weekly frequency of HF and NS was reduced from 75.7 to 46.9 (p < 0.03) at the posttreatment measure to 38.3 (p < 0.02) at the three-month follow-up. This change represents a 38% reduction at posttreatment and a 49% reduction at the three-month follow-up.
  • Problem rating was reduced from 6.3 to 3.4 at posttreatment (p < 0.0001) and to 2.6 at follow-up (p < 0.0001).
  • Depressed mood and anxiety significantly decreased from assessment to posttreatment (p < 0.02), and reductions were maintained at the three-month follow-up (p < 0.03).
  • Sleep improved significantly (p < 0.003).
  • Subscales of the SF-36® showed other significant improvements:  emotional role limitation (p < 0.0001), mental health (p < 0.01), energy/vitality (p < 0.0001), and general health (p < 0.003).
  • Total scores on the HFBS decreased significantly, from 28.2 to 22.4 at posttreatment (t = 3.77; df = 16; p < 0.002), and were maintained at 22.7 at follow-up (t = 4.34; df = 16; p < 0.001). These reductions reflected a significant change in beliefs.

Conclusions

  • Results suggest that CBT delivered in groups might offer a viable option for women with troublesome, undertreated, menopausal symptoms following breast cancer treatment, but further controlled trials are needed.
  • CBT is consistent with the preferred treatment of women surveyed.
  • Improvements continued after treatment, which may reflect the skills-learning aspect of CBT. HF and NS decreased, as did depressed mood and anxiety.
  • Sleep improved, as reported by changes in WHQ ratings.
  • Results showed no signficant improvement in specific dimensions of HRQOL, particularly emotional role limitation, energy/vitality, or mental health.

Limitations

  • The study had a small sample size, with less than 30 patients.
  • The study is of limited generalizability.
  • The main limitations of the study were lack of controls for placebo effects, attention, and spontaneous remission.
     

Nursing Implications

Nurses could be trained to conduct structured, interactive, group CBT with individual treatment goals. A randomized, controlled trial is recommended for further investigation.

Print

Hunter, M.S., Coventry, S., Hamed, H., Fentiman, I., & Grunfeld, E. A. (2009). Evaluation of a group cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psycho-Oncology, 18, 560–563.

Study Purpose

Primary aim: To evaluate the effectiveness of group cognitive behavioral therapy (CBT) on hot flashes and night sweats in women who have had breast cancer

Secondary aim: To evaluate the effect of group CBT on depressed mood, anxiety, sleep, and quality of life

Intervention Characteristics/Basic Study Process

The intervention consisted of six group sessions using a psychoeducational approach with education regarding hot flushes, relaxation, stress management, and sleep strategies.

The intervention was delivered by a psychologist plus a trainee/intern.

Relaxation and paced breathing were demonstrated and practiced in each session, and participants were given a CD for ongoing use.

Sample Characteristics

  • The sample was comprised of 17 women with breast cancer.
  • Mean age of participants was 53.7 years, with a range of 46–65 years.
  • Average time since diagnosis was 23.2 months; 82% had received chemotherapy and radiation therapy, and 71% were receiving adjuvant hormonal therapies.
  • Mean duration of hot flashes was 2.1 years.
  • Of the sample, 70% were employed and 53% had more than 16 years of education.

Setting

  • Single site (two breast units)
  • Other setting
  • London, England, United Kingdom

Phase of Care and Clinical Applications

  • Transition phase after initial treatment
  • Late effects and survivorship

Study Design

A pre/post-test design was used.

Measurement Instruments/Methods

  • Hot Flush Frequency and Problem Rating Scale (HFRS): Three 10-point Likert-type scales
  • Daily hot flush diaries completed during a two-week assessment and at the end of treatment
  • Women’s Health Questionnaire (WHQ): 36 items to assess mood and sleep
  • Short Form 36 (SF-36): 36 items to assess health-related quality of life
  • Hot Flush Beliefs Scale (HFBS)

Results

Depression and anxiety decreased from baseline to post-treatment (p < 0.006; p < 0.02). Reductions maintained at the three-month follow-up.

Conclusions

Results suggest that group CBT may be an effective option for women who have menopausal symptoms following breast cancer treatment.

Limitations

  • The sample was small.
  • Only 59% of participants completed all six sessions.

Nursing Implications

Participants had a mean duration of hot flushes of more than two years, suggesting that symptoms may have been unrelated to their recent cancer treatment and more associated with menopause.

Print

Hunter, A., Mahendra, P., Wilson, K., Fields, P., Cook, G., Peniket, A., … Marcus, R. (2009). Treatment of oral mucositis after peripheral blood SCT with ATL-104 mouthwash: Results from a randomized, double-blind, placebo-controlled trial. Bone Marrow Transplantation, 43, 563–569.

Study Purpose

To assess the tolerability of three ATL-104 doses and to assess the efficacy and safety of ATL-104 on mucositis in patients requiring high-dose melphalan or BEAM (carmustine, etoposide, cytarabine, and melphalan) before peripheral blood SCT (PBSCT)

Intervention Characteristics/Basic Study Process

This study included two parts. In the first part, patients were randomized to receive placebo or ATL-104 in doses of 50, 100, or 150 mg orally by mouthwash as a 15 mL total volume swilled in the mouth for 15-30 seconds and then swallowed. ATL-104 is a plant lectin associated with mitogenic activity and epithelial cell growth. Following harvest of PBSCs, patients received study treatment for three days before beginning a course of chemotherapy. For patients receiving BEAM, chemotherapy lasted for six days, whereas patients receiving high-dose melphalan had one day of treatment. PBSCT was administered 1–2 days after completion of chemotherapy, and patients then received three once daily doses of ATL-104. In the second part, patients were randomized to placebo or to one of the three ATL-104 doses.

Sample Characteristics

  • The study reported on 63 patients with a mean age of 53.3 years.
  • The sample had 17 females and 46 males.
  • The majority of patients (60.3%) received high-dose melphalan chemotherapy for multiple myeloma, and 39.7% received BEAM chemotherapy for lymphoma.

Setting

The study was conducted in an inpatient setting in the United Kingdom.

Study Design

  • Part 1 was a randomized, double-blind, placebo-controlled phase IIa dose escalation study.
  • Part 2 was a randomized, double-blind, placebo-controlled parallel group study.

Measurement Instruments/Methods

  • The extent and severity of mucositis was assessed daily from screening until the final assessment, which was performed 28 days after the last dose of ATL-104 or at withdrawal.
  • World Health Organization (WHO) and Western Consortium for Cancer Nursing Research (WCCNR) toxicity scales were used.

Results

Treatment with ATL-104 substantially reduced the median duration of severe oral mucositis compared with placebo (median duration: ATL-104 for two to three days, placebo 10.5 days) (p < 0.001). The effect of ATL-104 on the incidence of severe oral mucositis was inconclusive. Adverse events (AEs) were mild to moderate in intensity with gastrointestinal (GI) AEs being most common.

Conclusions

ALT-104 substantially reduced the duration of severe mucositis and was well tolerated.

Limitations

This study had inconclusive results regarding the incidence of severe mucositis. Further studies with a larger number of patients are needed to establish the effects of ATL-104 on the duration and severity of mucositis. Limited range of ATL-104 doses may be responsible for the lack of dose-response.

Nursing Implications

Mouthwashes are easy to administer; however, adherence is a concern when used preventatively or when the patient has oral discomfort or fatigue. The hospital setting allows for easier monitoring and assistance in promoting adherence. If further studies show a benefit to patients, cost and availability will be influencing factors toward good outcomes.

Print

Huisman, M., van den Bosch, M.A., Wijlemans, J.W., van Vulpen, M., van der Linden, Y.M., & Verkooijen, H.M. (2012). Effectiveness of reirradiation for painful bone metastases: A systematic review and meta-analysis. International Journal of Radiation Oncology, Biology, Physics, 84, 8–14.

Purpose

STUDY PURPOSE: To assess pain response after reirradiation in patients with painful bone metastases not sufficiently responding to initial radiation therapy or exhibiting recurrent pain after initial response

TYPE OF STUDY: Combined systematic review and meta-analysis

Search Strategy

DATABASES USED: MEDLINE, EMBASE, and Cochrane Collaboration library

KEYWORDS: Radiotherapy, reirradiation, retreatment, bone metastases, palliative treatment

INCLUSION CRITERIA: All types of studies were allowed. Participants received reirradiation at the initial site of radiation for radiation-refractory metastatic bone pain. Both the initial treatment and retreatment consisted of external beam radiation therapy (EBRT). Reported outcomes were reported at least in response to initial reirradiation, and original research data were reported. If eligibility for inclusion could not be decided based on abstract screening, or if the abstract was not available, the full-text article was reviewed. To qualify for the meta-analysis, the study had to meet additional criteria: outcomes were available on an individual patient level, and the size of the study population was 10 patients or more.

EXCLUSION CRITERIA: Languages other than English, German, French, and Dutch

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 707

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Authors were contacted for missing data. Publication quality was assessed using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) method. Data extraction and quality assessment was performed independently by two observers.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 10 (qualitative synthesis), 7 (meta-analysis)
  • TOTAL PATIENTS INCLUDED IN REVIEW = 440
  • SAMPLE RANGE ACROSS STUDIES: 11%–24% of patients observed received reirradiation, numbering from 4–173 cases
  • KEY SAMPLE CHARACTERISTICS: Sample characteristics were available in two studies. One study (Van Der Linden et al.) reported that 61% of participants were male, 39% were female, the mean age was 65, and the mean Karnofsky Performance Status was 70. In a second study (Hayalshi et al.), it was reported that 57% of participants were male, 43% were female, the median age was 60, and the mean Eastern Cooperative Oncology Group (ECOG) performance status score was 2.5. Primary tumor types were breast (33%), prostate (21%), lung (23%), and other tumor types (23%). Reirradiated sites were localized to the spine (36%), pelvis (38%), proximal long bones (12%), and other locations (14%). Most patients were treated with single-fraction radiotherapy.

Phase of Care and Clinical Applications

PHASE OF CARE: Transitional care after initial treatment

APPLICATIONS: Late-effects, survivorship, and palliative care

Results

In this meta-analysis, 264 out of 440 patients achieved either complete or partial response with an overall response rate of 58%. Sensitivity analysis was not feasible. The complete response rate for reirradiation ranged from 16%–28%, and partial response rates were 28%–45%. Pooling was not appropriate due to the low number of studies. The time to response after reirradiation ranged from three to five weeks.

Conclusions

Approximately 60% of patients derived some benefit from the reirradiation of radiation-refractory bone pain. The time to response was three to five weeks. For those receiving reirradiation in a circumstance in which the end of life is near, this method may not be effective. Remission of pain, however, was reported to last anywhere from 15–22 weeks.

Limitations

Not all studies reported drop-out rates and so an intention to treat analysis was not feasible. If reported, however, drop-out rates ranged from 14%–35%. These rates were attributed to death and symptomatic relief but were not clear, so bias could not be excluded. Further, no randomized, controlled trial has been published on reirradiation treatment for radiation-refractory metastatic bone pain. There is limited evidence on reirradiation effectiveness, study quality is mediocre, and populations are small. Also, the difference in study design, clinical differences between study populations, lack of clinical guidelines for reirradiation, and changes in insight over time contributed to the heterogeneity observed in the included studies. All of these factors again support the need for ongoing investigation of reirradiation for bone metastases and further investigation of palliative care measures to provide optimal relief for patients with painful bone metastases.

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