Carson, J. W., Carson, K. M., Porter, L. S., Keefe, F. J., & Seewaldt, V. L. (2009). Yoga of Awareness program for menopausal symptoms in breast cancer survivors: results from a randomized trial. Supportive Care in Cancer, 17, 1301–1309.
The study evaluated the effects of a yoga intervention on menopausal symptoms among breast cancer survivors.
Patients were randomized to the yoga intervention or a wait-list control group. The intervention consisted of eight weekly, 120-minute, group classes led by a certified yoga instructor. Classes were videotaped and reviewed. Sessions involved 40 minutes of stretching poses, 10 minutes of breathing techniques, 25 minutes of meditation, 20 minutes of study of pertinent topics, and 25 minutes of group discussion. CD recordings were provided for home practice. Application of concepts to daily life were assigned weekly. Assessments were performed at baseline, posttreatment, and three months postintervention. Wait-list controls were reminded about the assessments they needed. Patients kept daily diaries to rate hot flashes and daily use of yoga.
The study was performed in outpatient clinics at Duke University.
The study was a randomized, controlled trial.
Those in the yoga group had a significantly better decline in hot flash frequency, severity, joint pain, fatigue, and sleep disturbance (p < 0.002). Patients in the control group had significantly better decline in the degree to which they were bothered by symptoms (p < 0.0001). There was no difference in night sweats. Mean yoga practice time spent in use of techniques was associated with less fatigue (p = 0.032). Yoga daily participation ranged from 7.3 to 64.6 minutes. There was a 76% completion rate in the yoga group.
The findings suggested a potential benefit of a group yoga and support intervention for some symptoms in breast cancer survivors.
The findings suggested that yoga and support activities provided in a group setting may help patients with symptoms of hot flashes, sleep deprivation, and fatigue. There was no apparent effect on night sweats.
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.
To examine the efficacy of two doses of venlafaxine: 37.5 mg (low-dose study) or 75 mg (high-dose study) to treat hot flashes after breast cancer.
Women were scheduled for 14 weekly visits. Weeks 1 and 2 provided baseline information, and weeks 3 to 14 included six weeks of treatment and six weeks of placebo.
Outcomes were hot flash (frequency, severity, and bother), hot flash impact on daily life, negative effect, fatigue, sleep, and quality of life (QOL).
The sample was comprised of breast cancer survivors: 57 in the low-dose study and 20 in the high-dose study.
University cancer clinics in the southeastern and midwestern United States
Patients were undergoing the long-term follow-up phase of care.
The study included two randomized, double-blind, placebo-controlled, crossover trials.
Venlafaxine resulted in modest decreases in hot flashes, but only hot flash interference improved differentially at the higher dose. The timing of the effect of venlafaxine on hot flashes varied by dose.
Only women with a 50% or greater decrease in physiologic hot flashes experienced significant improvement in fatigue, sleep quality, and QOL. Although side effects were mild, most patients discontinued venlafaxine long-term.
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.
To pilot test the acceptability of a DVD platform to deliver a newly created cognitive-behavioral hot flash intervention and estimate its efficacy.
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.
The study was conducted at outpatient cancer clinics serving rural and urban areas in the midwestern and southeastern United States.
Patients were undergoing the long-term follow-up phase of care.
This was a nonrandomized, pre/post-test pilot study design.
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.
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.
Examination of venlafaxine at two doses for efficacy in relation to physiologic and self-reported hot flashes and other outcomes
Outpatient cancer clinics
Randomized, double-blind, placebo-controlled crossover trial
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.
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.
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:
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.
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.
The study was conducted in university cancer clinics in the southeast (low-dose study) and midwest (high-dose study) United States.
Active treatment
Randomized, Double-blind, placebo-controlled, crossover trials:
Profile of Mood States–Short Form (fatigue subscale)
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).
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
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.
To evaluate long-term effects of completed decongestive therapy (CDT) on lower-extremity lymphedema
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.
The study was conducted at a single-site, outpatient setting in Italy.
A retrospective analysis and follow-up design was used.
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.
The study provided limited information about longer-term outcomes of patients with lymphedema secondary to melanoma.
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.
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.
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
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.
The study was conducted at multiple Gynecologic Oncology Group member institutions across the United States.
The study used a randomized phase III trial design.
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).
VH fibrin sealant in inguinal lymphadenectomies does not reduce leg lymphedema and may increase the risk for complications in the vulvar wound.
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.
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.
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.
Patients were undergoing the long-term follow-up phase of care.
The study used a prospective, repeated measures, quasiexperimental, feasibility design with one group.
Pittsburgh Sleep Quality Index (PSQI)
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.
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.
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.
Patients were undergoing the long-term follow-up phase of care.
The study used a one-group, pre- and posttest design.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30) sleep disturbance subscale
Significant improvements were reported in sleep quality.
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.
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.
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.