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Carpenter, J. S., Neal, J. G., Payne, J., Kimmick, G., & Storniolo, A. M. (2007). Cognitive-behavioral intervention for hot flashes. Oncology Nursing Forum, 34, E1–E8.

Study Purpose

To pilot test the acceptability of a DVD platform to deliver a newly created cognitive-behavioral hot flash intervention and estimate its efficacy.

Intervention Characteristics/Basic Study Process

Participants viewed a DVD consisting of video clips demonstrating the intervention, which included one cognitive activity (distraction) and two behaviors (remain still, breathe). The video clips demonstrated the intervention during three situations:  resting at home, during housework, and in a work environment. Participants were asked to practice the intervention for one week. Outcomes measured were hot flash occurrence, severity, bother, mood disturbance, affect, hot flash disruption, and sleep disturbances.

Sample Characteristics

  • The sample was comprised of 49 women (26 at site 1 and 23 at site 2), with 40 completing all aspects of the study.
  • Women with any stage of breast cancer or at high risk for disease were included.
  • Mean age was 54.42 years, and all women were 21 years or older and experiencing hot flashes (93% were postmenopausal).
  • Of the women, 75% were Caucasian.

Setting

The study was conducted at outpatient cancer clinics serving rural and urban areas in the midwestern and southeastern United States.

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

This was a nonrandomized, pre/post-test pilot study design.

Measurement Instruments/Methods

  • Center for Epidemiologic Studies Depression Scale (CESD)
  • Profile of Mood States–Short Form (POMS-SF)
  • Positive and Negative Affect Schedule (PANAS)
  • Biolog®3991
  • Hot flash severity and bother numeric rating scales
  • Hot Flash-Related Daily Interference Scale (HFRDIS)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Actiwatch®

Results

The DVD was an accepted and feasible intervention delivery method. Although statistically significant improvement in hot flash parameters was observed, changes were equal to about a 10% change. The 10% reduction in hot flashes affected related outcomes, with the HFRDIS improving in all participants and CESD scores improving in the subset that reported the worst hot flash severity. No change in affect or sleep was noted.

Limitations

  • The unblinded, single-group design allows for placebo effect.
  • The study had a small sample size.
  • There was difficulty quantifying the frequency of intervention use; therefore, the variable was not included in the analyses.
  • Drawbacks to using a DVD include the one-way nature of instruction and limited opportunity for participants to ask questions.
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Carpenter, J.S., Storniolo, A.M., Johns, S., Monahan, P.O., Azzouz, F., Elam, J.L., … Shelton, R.C. (2007). Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist, 12, 124–135.

Study Purpose

Examination of venlafaxine at two doses for efficacy in relation to physiologic and self-reported hot flashes and other outcomes

Intervention Characteristics/Basic Study Process

  • Study duration: 14 weeks 
  • Low-dose arm:  6 weeks at 37.5 mgof venlafaxine daily 
  • High-dose arm: consisted of 1 week of 37.5 mg of venlafaxine daily, 4 weeks of 75 mg daily, and one week of 37.5 mg daily
  • Weeks 1 and 2 provided baseline data 
  • Weeks 3–14 included 6 weeks of treatment and 6 weeks of placebo

Sample Characteristics

  • Breast cancer survivors  recruited between 2000–2004 with follow up continuing through 2005 
  • Must have been postmenopausal or using an approved method of birth control
  • Low-dose study (n = 64, cancer clinics in the Southeast)
  • High-dose study (n = 20, cancer clinics in the Midwest)

Setting

Outpatient cancer clinics

Study Design

Randomized, double-blind, placebo-controlled crossover trial

Measurement Instruments/Methods

A psychologist verified absence of depressive symptoms using two measures: Structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders and the 17-item Hamilton rating scale depression. Adherence to the treatment was assessed using capsule counts and weekly written verification. Physiologic hot flash frequency was evaluated using weekly 24-hour ambulatory sterna skin conductance monitoring and self-reported hot flash diaries. Weekly blood pressure monitoring and other tools were used for side effect monitoring.

Results

Venlafaxine resulted in modest hot flash reduction, but only hot flash interference improved differentially at the higher dose. Timing of effects varied by dose. Only women who experienced a greater than 50% decrease in physiologic hot flashes also experienced a significant improvement in fatigue, sleep quality, and QOL. Although side effects were mild, most patients discontinued venlafaxine long term.

Limitations

A placebo effect occurred for self-report of hot flashes but not for physiologic hot flashes in the high- and low-dose arms.

Main study limitations:

  • Racially and ethnically homogeneous samples
  • Limited treatment time
  • Small sample size
  • Lack of pharmacogenetic data. Also limitations regarding
  • Assessing hot flashes with self-reporting is subject to placebo effects
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Carpenter, J.S., Storniolo, A.M., Johns, S., Monahan, P.O., Azzouz, G., Elam, J.L., . . . Shelton, R.C. (2007). Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist, 12(1), 124–135.

Intervention Characteristics/Basic Study Process

Each study intervention lasted for 14 weeks. The low-dose study treatment required patients to take 37.5 mg/day of venlafaxine. The high-dose treatment required patients to take venlafaxine at 37.5 mg/day for one week, followed by 75 mg/day for four weeks, followed by 37.5 mg/day for one week. Women were scheduled for 14 weekly visits. Weeks 1 and 2 provided baseline information, and weeks 3–14 consisted of six weeks of treatment (T1–T6) and six weeks of placebo (P1–P6). Trained nurses visited patients in the clinic, at home, or in their workplace to maintain consistent follow-up. Patients were telephoned 1, 6, and 12 months after completing the weekly visits to assess continued venlafaxine use.

Sample Characteristics

  • The study included 77 breast cancer survivors.
  • Low-dose study group
    • Mean age = 50.5 years, mainly non-Hispanic whites (91%), married (81%), and working full-time (60%).
    • Mostly stage II or less at diagnosis (96%), and had received radiation (68%), chemotherapy (70%), or both (51%).
    • 51% were taking endocrine therapy.
  • High-dose study group:
    • Mean age = 53 years, mostly non-Hispanic whites (90%), married (53%), and working full-time (63%)
    • Mostly stage II or less at diagnosis (94%), taking endocrine therapy (63%), had received radiation (58%), chemotherapy (63%), or both (38%).
  • Patients were excluded if they used tamoxifen or aromatase inhibitor for less than six weeks, were taking antidepressants, received hot flash treatment within the past four weeks, or were pregnant or lactating.

Setting

The study was conducted in university cancer clinics in the southeast (low-dose study) and midwest (high-dose study) United States.

Phase of Care and Clinical Applications

Active treatment

Study Design

Randomized, Double-blind, placebo-controlled, crossover trials:

  1. Low-dose study (N=57)
  2. High-dose study (N=20)

Measurement Instruments/Methods

Profile of Mood States–Short Form (fatigue subscale)

Results

Overall fatigue did not improve with the venlafaxine treatment when compared with the placebo. However, a subgroup of 15 women who received venlafaxine and had a 50% or greater decrease in physiologic hot flashes experienced a significant improvement in fatigue from baseline to six weeks compared to the placebo group (p = 0.007).

Limitations

Homogenous sample in respect to race and ethnicity Small sample size Limited treatment time Lack of pharmacogenetic data (i.e. did not evaluate genetic polymorphisms in patients which may have explained observed response to venlafaxine treatment

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Carmeli, E., & Bartoletti, R. (2011). Retrospective trial of complete decongestive physical therapy for lower extremity secondary lymphedema in melanoma patients. Supportive Care in Cancer, 19(1), 141–147.

Study Purpose

To evaluate long-term effects of completed decongestive therapy (CDT) on lower-extremity lymphedema 

Intervention Characteristics/Basic Study Process

Patients who had been treated for lower-extremity lymphedema secondary to melanoma treatment from January 2006 to July 2009 were invited to participate in reevaluation. Patients participated in a interview and measurement of limb circumference. Treatment that had been provided included initial phase 1 treatment (five consecutive days of manual lymph drainage [MLD], compression bandaging, and exercises with bandages) and phase 2 maintenance treatment (skin care, supporting garments, low-stretch bandages, and a set of 10-minute exercises to be done at home). During active phases, patients completed comprehensive assessment via chart items developed by the Italian Lymphedema Association, including demographic and disease data and quality-of-life items rated by patients on a visual analog scale.

Sample Characteristics

  • The sample (N = 12) was 25% male and 75% female.
  • All patients had melanoma that had been previously treated in the past one to four years, at least one lymph node removed from the groin area, and unilateral secondary lymphedema diagnosed by lymphoscintigraphy.
  • Participants were excluded if they had complete decongestive therapy within the previous six months.

Setting

The study was conducted at a single-site, outpatient setting in Italy.

Phase of Care and Clinical Applications

  • Patients were in the long-term follow-up phase of care.
  • This study has clinical applicability for late effects and survivorship.

Study Design

A retrospective analysis and follow-up design was used.

Measurement Instruments/Methods

  • Limb circumference measurements were taken.
  • In-depth interview (IDI) questionnaire history (IDI not defined) and quality-of-life information were obtained.

Results

Findings showed that from baseline to the end of initial active treatment with CDT, the percent change in limb volume was –34%, and from baseline to the reevaluation for was –17% (p = 0.05). Patients with higher body mass index (BMI) reported significantly lower quality-of-life results (p < 0.05). Sixty percent of patients reported good compliance with the use of garments, bandages, and exercises.

Conclusions

The study provided limited information about longer-term outcomes of patients with lymphedema secondary to melanoma.

Limitations

  • The small sample (N < 30) and other study method questions limit utility of findings.
  • The study had no comparison or controls.
  • Procedures stated that all interviews and measurements were done by the same therapist, who was blinded to all prior measures; however, the authors did not explain how this was accomplished.
  • Time from initial treatment was highly variable at one to four years.
  • How the percent change at the reevaluation was significantly lower than baseline, when prior change that was greater was not significant, is unclear.

Nursing Implications

Study findings provided minimal information about the longer-term results from CDT for lower-limb lymphedema in patients who had melanoma. Information about management of lower-extremity lymphedema and long-range outcomes related to lymphedema and management approaches is limited. Further research in these areas is needed.

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Carlson, J.W., Kauderer, J., Walker, J.L., Gold, M.A., O'Malley, D., Tuller, E., . . . Gynecologic Oncology Group. (2008). A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: A Gynecologic Oncology Group Study. Gynecologic Oncology, 110(1), 76–82.

Study Purpose

To test the hypothesis that patients who receive a vapor-heated (VH) fibrin sealant in the inguinal wound following inguinal lymphadenectomy in conjunction with treatment of a vulvar neoplasm would experience a 25% reduction in the incidence of grade 2 and 3 lymphedema of the lower extremity compared to control patients

Intervention Characteristics/Basic Study Process

Patients were randomized to the investigational or control arm of the study. In the investigational arm (FS), VH fibrin sealant was applied to the inguinal wound base. In the control arm (SC), the closure of the wound was performed without application of the fibrin sealant. Patients were assessed prior to treatment and postoperatively at the time of drain removal, at six weeks, and at three and six months.

Sample Characteristics

  • The study sample (N = 137) was comprised of female patients with a vulvar malignancy.
  • Patients were randomized to the FS arm (n = 70) or the SC arm (n = 67).
  • Median age in the FS arm was 61 years, with a range of 30–90 years; median age in the SC arm was 57 years, with a range of 33–87 years.
  • All patients were undergoing a radical vulvectomy or hemivulvectomy with either an ipsilateral or bilateral inguinal lymphadenectomy.

Setting

The study was conducted at multiple Gynecologic Oncology Group member institutions across the United States.

Study Design

The study used a randomized phase III trial design.

Measurement Instruments/Methods

  • Circumference was measured to determine leg lymphedema.
  • Surgical complications were measured, including vulvar wound separation, inguinal wound separation, grading of infection or cellulitis, and grading of seroma or lymphocyst.
  • Duration of drain and drain output in the 24 hours prior to drain discontinuation also were evaluated.

Results

The incidence of grade 2 and 3 lymphedema was 67% in the SC arm and 60% in the FS arm (p = 0.4779). The incidence of lymphedema was strongly associated with inguinal infection (p = 0.0165). No statistically significant difference was found in duration of drains or drain output or incidence of inguinal infections, wound breakdowns, or seromas. The FS arm experienced an increased incidence of vulvar infections (p = 0.0098).

Conclusions

VH fibrin sealant in inguinal lymphadenectomies does not reduce leg lymphedema and may increase the risk for complications in the vulvar wound.

Limitations

  • The sample size in each group was small, with less than 100 participants.
  • Follow-up for circumferential measurement occurred only through six months.
  • The protocol prescribed 10–15 lb of pressure over the wound bed after the VH fibrin sealant had been applied, but the exact location and amount of pressure over the wound was not monitored.

Nursing Implications

Future trials should be designed to evaluate surgical techniques and postoperative care that would decrease wound breakdowns and complications while monitoring for variables that may be related to increased incidence of swelling or lymphedema in patients with vulvar cancer.

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Carlson, L. E., & Garland, S. N. (2005). Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. International Journal of Behavioral Medicine, 12, 278–285.

Intervention Characteristics/Basic Study Process

The mindfulness-based stress reduction (MBSR) meditation program included relaxation, meditation, gentle yoga, and daily practice. Patients attended eight sessions and received a 52-page booklet with weekly instructions plus an audiotape of the meditations. Outcomes were sleep, mood, stress, and fatigue.

Sample Characteristics

  • The sample was comprised of 63 patients (49 women, 14 men).
  • Mean age was 54 years (range 32–78).
  • Patients had mixed cancer diagnoses and stages.

Setting

  • Outpatient
  • Canada

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

The study used a prospective, repeated measures, quasiexperimental, feasibility design with one group.

Measurement Instruments/Methods

Pittsburgh Sleep Quality Index (PSQI)

Results

At pretreatment, 91% of the sample had a PSQI of 5 or more and 51% had a score of 10 or more. At posttreatment, 27% reported a PSQI of greater than 10. Sleep disturbance was significantly reduced, and subjective sleep quality was improved.

Limitations

  • The study lacked a control or comparison group; also, only a subjective sleep measurement was used. The relative importance of different components of the intervention is not known.
  • Training in delivering the intervention is needed.
  • Cost is incurred for a space for the class and for an instructor.

 

Print

Carlson, L. E., Speca, M., Patel, K. D., & Goodey, E. (2003). Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosomatic Medicine, 65, 571–581.

Intervention Characteristics/Basic Study Process

The mindfulness-based stress reduction (MBSR) meditation program included relaxation, meditation, gentle yoga, and daily practice. Patients received a 52-page booklet with weekly instructions and an audiotape of the meditations. Patients attended eight weekly, 90-minute group sessions plus a three-hour silent retreat on Saturdays on weeks 6 and 7. Outcomes were quality of life (QOL), mood, symptoms of stress, and immune and hormone parameters.

Sample Characteristics

  • Pretest, the sample was comprised of 59 patients (49 patients with stage 0, I, or II breast cancer and 10 with early stage prostate cancer).
  • Posttest, the sample was comprised of 42 patients.

Setting

  • Outpatient
  • Canada

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

The study used a one-group, pre- and posttest design.

Measurement Instruments/Methods

European Organisation for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30) sleep disturbance subscale

Results

Significant improvements were reported in sleep quality.

Limitations

  • The study lacked control of the comparison group.
  • The relative importance of different components of the intervention is not known. Improvement in sleep was not correlated with the degree of program attendance or minutes of home practice.
  • Training in delivering the intervention is needed.
  • Cost is incurred for a space for the class and an instructor.
Print

Carlson, L.E., & Garland, S.N. (2005). Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. International Journal of Behavioral Medicine, 12, 278–285.

Intervention Characteristics/Basic Study Process

The mindfulness-based stress reduction (MBSR) intervention was provided over eight weekly 90-minute group sessions. Details of the intervention have been previously described in Carlson et al. (2003). Participants were asked to complete 45 minutes of meditation homework six days a week and recorded their progress in a homework log. Patient outcomes were assessed at baseline and at week 8.

Sample Characteristics

  • N = 63
  • MEAN AGE =54 years
  • AGE RANGE = 32–78 years
  • FEMALES: 78%
  • KEY DISEASE CHARACTERISTICS: Patients with cancer—cancer diagnoses were varied, with the most common being breast (59%), followed by prostate, ovarian, and non-Hodgkin lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority of participants was married (71%) and well educated (mean = 16 years of formal education)

Setting

  • LOCATION: Tom Baker Cancer Center

Study Design

  • Pre-post intervention study

Measurement Instruments/Methods

  • Profile of Mood States (POMS)

Results

The MBSR intervention resulted in a statistically significant improvement in fatigue when comparing pre- and post-test outcomes (p < 0.001). Statistically significant relationships also were found between changes in symptoms of stress and fatigue (p < 0.001), as well as changes in mood disturbance and fatigue (p < 0.001). Therefore, with less fatigue, patients also were less stressed and less moody.

Limitations

  • Lack of a control group
  • Cannot determine which aspects of the intervention led to observed improvements in fatigue because MBSR is delivered in a multimodal format
  • Lack of a specific measure to assess fatigue
  • No follow-up assessment; therefore, long-term effects of MBSR remain unknown
Print

Carlson, L.E., Speca, M., Patel, K.D., & Goodey, E. (2003). Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosomatic Medicine, 65, 571–581.

Intervention Characteristics/Basic Study Process

Didactic, inductive, and experiential modes of learning were used to implement the intervention and convey information to patients. The intervention was provided over the course of eight weekly 90-minute group sessions (maximum of 15 participants per group) as well as a three-hour silent retreat on Saturday between weeks 6 and 7.

Patients received a booklet containing information about each week’s instructions as well as an audiotape with sensate-focused body scan meditation on one side and a guided sitting meditation on the other.

The program was composed of three primary components.

  1. Theoretical materials related to mindfulness, relaxation, meditation, and the mind-body connection
  2. Experiential practice of meditation and yoga during group meetings and home-based practice
  3. Group process focused on problem-solving concerning obstacles to effective practice, daily applications of mindfulness, and supportive interaction between group members

Sample Characteristics

  • N = 59
  • MEAN AGE = 54.5 years
  • KEY DISEASE CHARACTERISTICS: 49 women with breast cancer and 10 men with prostate cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Most patients (N = 42) were married or cohabiting, with a mean of 14.7 years of formal education. Patients had a median cancer diagnosis of 1.1 years prior to study enrollment (range = three months to 20 years). Two-thirds had stage II cancer (62.7%).
  • EXCLUSION CRITERIA: Treatment with chemotherapy, radiation therapy, or hormone therapy currently or within the past three months; psychiatric illness; a concurrent autoimmune disorder; and past participation in a mindfulness-based stress reduction (MBSR) group
  • RECRUITMENT: Patients primarily were recruited with pamphlets and posters around the center, in each of the breast and prostate clinic areas, and were able to self-refer.

Setting

  • LOCATION: Tom Baker Cancer Center

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

  • Pre-post intervention study

Measurement Instruments/Methods

  • European Organization for Research and Treatment in Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
  • Profile of Mood States (POMS)

Results

The MBSR intervention did not result in a significant difference for fatigue outcomes between pre- and post-intervention time points. Only 42 patients had complete data for both time points. When comparing the 17 patients with incomplete data to the rest of the sample, participants with complete data were more likely to be married or cohabitating. Non-completers had higher scores than completers on several of the baseline measures for POMS subscale, including depression, anger, and confusion.

Limitations

  • Lack of a neutral comparison group
  • Lack of correction for multiple comparisons during statistical analysis
Print

Carl, H.M., Walia, G., Bello, R., Clarke-Pearson, E., Hassanein, A.H., Cho, B., . . . Sacks, J.M. (2017). Systematic review of the surgical treatment of extremity lymphedema. Journal of Reconstructive Microsurgery. Advance online publication. 

Purpose

STUDY PURPOSE: To examine the results of various surgical treatment for lymphema

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, Scopus, Web of Science, and Cochrane Collaboration from January 2000–May 2016
 
INCLUSION CRITERIA: Minimum sample of eight patients; study describing surgical treatment for extremity lymphedema
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Not reported
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: MINORS scoring system was used. Highly valid studies were based on scores of 12 of 16 points or 19 of 24 points.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 69 studies met inclusion criteria.
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not provided
  • SAMPLE RANGE ACROSS STUDIES: Not provided

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

  • Five studies involving excisional procedures, including 76 patients reporting limb volume reduction ranging from 16%–52%; four of the five studies reported multiple complications from the procedures.
  • Four studies, including 105 patients with lower or upper extremity lymphedema reporting the effects of liposuction procedures; the weighted average percent of volume reduction was 96.63%.
  • Lymphatic reconstruction procedures reported a weighted average for limb reduction of 5.8%. Lymphaticovenous anastomosis results were reported in 12 studies.
  • Ten studies reported results from 185 patients who had tissue transfer procedures. For these, the weighted average limb reduction based on circumference was 39.5%.
  • Eight studies, including 135 patients reporting the use of multiple surgical approaches; the combinations of techniques were varied.
  • Studies varied regarding continued use of compression garments and physiotherapy postoperatively.
  • Based on the results of this review, the authors provided an algorithm for decision making in the application of various surgical techniques.

Conclusions

The findings suggest that various surgical techniques can be effective to reduce limb volume; however, the research has several limitations. Relatively few studies examine each specific technique, and little evidence comparing these techniques to outcomes with other interventions known to be effective exists.

Limitations

  • High heterogeneity
  • Low sample sizes
  • Varied methods of measuring lymphedema

Nursing Implications

A variety of surgical techniques and microsurgical procedures are being evaluated for their effects on the development of lymphedema. Currently, limited evidence supports any particular procedure or technique. Nurses should be aware of any potential long-term side effects of such procedures as this information becomes available.

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