A randomized placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients undergoing radiation therapy.

PURPOSE: This is a pilot study investigating the effect of healing touch (HT) on fatigue in breast cancer patients undergoing radiation therapy (RT). METHODS/DESIGN: This study presents the results of a within-subjects design randomized clinical trial where the treatment group was treated with HT, whereas the control group experienced sham therapy. The setting was a university RT clinic. The participants were breast cancer patients treated with lumpectomy or mastectomy, 21 to 75 years old with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2. The intervention was a 45-minute session of HT or sham therapy once a week during RT. Outcome measures included fatigue, quality of life (QOL), and anxiety/depression. RESULT: A total of 70 patients were approached, with 41 completing the study. At completion, the HT participants tended to report higher levels of fatigue, statistically significant for interference ( : = .010) and usual fatigue ( : = .024). The control group tended to report greater reductions in fatigue relative to their own means than the HT group (Cohen's : = 0.30 to 0.49 vs 0.06 to 0.18, respectively). There were no statistically significant differences between the groups for QOL. CONCLUSION: Our enrollment and retention indicate that HT is feasible for women during RT. Our pilot findings do not support a beneficial effect of HT on fatigue or QOL. Future research may explore increasing dose and teasing out therapist effect.

The negative effect of pretransplant overweight and obesity on the rate of improvement in physical quality of life after liver transplantation.

BACKGROUND: Recent studies suggest that obesity does not affect survival after liver transplantation. Overweight and obesity, however, impair health-related quality of life (HRQOL) in patients with chronic illnesses. We tested the effect of pretransplant body weight on HRQOL in liver transplant recipients. METHODS: Prospective, longitudinal HRQOL data were collected using the SF-36 health survey. Pretransplant body weight was stratified based on body mass index (BMI), as follows: normal (18.5-24.9), overweight (25.0-29.9), and obese (> or =30.0). Linear mixed-effects models were used to test the effects pretransplant BMI category on the trajectory of HRQOL after liver transplantation. RESULTS: The sample included 154 adults who underwent liver transplantation. Thirty-one percent had normal BMI, 41% were overweight, and 28% were obese pretransplant. The mean pretransplant physical HRQOL did not differ by BMI group (P > or = .697). Physical and mental HRQOL improved (P < .001) in all groups after transplantation, but the rate of improvement in physical HRQOL was significantly greater during the first year posttransplant in the normal BMI compared with the overweight and obese patients (P < or = .032). There was no effect of BMI on the rate of improvement in mental HRQOL. CONCLUSION: Excess pretransplant body weight hinders the rate of improvement in physical quality of life during the first year after liver transplantation.

The validity of EQ-5D US preference weights in liver transplant candidates and recipients.

Health utility instruments assess patients' valuation of specific health states, which can be converted to quality-adjusted life years for cost-utility analysis. Data from the EQ-5D, a generic health-related quality of life questionnaire from EuroQoL, can be reported as 5 health status scores or as a single health preference weight (HPW). US population-based HPWs were published by Shaw and colleagues in 2005 (Med Care 2005;43:203-220). Our aim was to test the validity of US EQ-5D HPWs and health status scores in liver transplant patients. EQ-5D scores were converted to HPWs with Shaw et al.'s model. Data were stratified by measurement period: pretransplant period, early posttransplant period (< or =12 months), intermediate posttransplant period (13-36 months), and late posttransplant period (>36 months). EQ-5D scores were compared to specific, hypothesized Short Form 36 Health Survey, Center for Epidemiologic Studies Depression Scale, and Beck Anxiety Inventory scores that were identified a priori on the basis of construct similarity. Criterion-related and construct validity were tested with nonparametric methods. Two hundred eighty-five adults participated (113 in the pretransplant period, 60 in the early posttransplant period, 47 in the intermediate posttransplant period, and 65 in the late posttransplant period), and follow-up averaged 36 +/- 36 months. Eighty-one percent of the hypothesized relationships between EQ-5D and gold-standard scales were strong (r > or = |0.5|, P < 0.001), and the remainder were moderate (r > |0.3|, P < 0.001). Differences between pretransplant and posttransplant EQ-5D HPWs were statistically significant. In conclusion, EQ-5D dimensions and the health utility index generated from Shaw's US population preference weights demonstrated criterion-related and construct validity in liver transplant patients. It is a valid instrument for cost-utility analysis in this setting.

The effects of physical quality of life, time, and gender on change in symptoms of anxiety and depression after liver transplantation.

Previous research demonstrated that physical health-related quality of life (HRQOL) improves after liver transplantation, but improvements in mental HRQOL are less dramatic. The aim of this study was to test the effects of physical HRQOL, time post-transplant, and gender on pre- to post-transplant change in anxiety and depression. Longitudinal HRQOL data were prospectively collected at specific times before and after liver transplantation using the SF-36(R) Health Survey (SF-36), Center for Epidemiologic Studies Depression Scale (CES-D), and Beck Anxiety Inventory (BAI). Within-subject change scores were computed to represent the longest follow-up interval for each patient. Multiple regression was used to test the effects of baseline score, time post-transplant, gender, and SF-36 physical component summary scores (PCS) on change in BAI and CES-D scores. About 107 patients (74% male, age=54+/-8 years) were included in the analysis. Time post-transplant ranged 1 to 39 months (mean=9+/-8). Improvement in symptoms of anxiety and depression was greatest in those patients with the most severe pre-transplant symptoms. Significant improvement in symptoms of depression occurred after liver transplant, but the magnitude of improvement was smaller with time suggesting possible relapse of symptoms. Better post-transplant physical HRQOL was associated with a greater reduction in symptoms of anxiety and depression after liver transplantation. This demonstrates clear improvements in post-transplant mental HRQOL and the significant relationships between physical and mental HRQOL.