BACKGROUND. This pilot randomized controlled trial (RCT) examined the clinical effects of 2 complementary (CAM) therapies, relaxation response therapy (RRT) and Reiki therapy, in men being treated with external beam radiotherapy (EBRx) for prostate cancer. METHODS. Study participants were randomly assigned to weekly RRT, Reiki therapy twice weekly, or wait-list control. Well-validated instruments measured anxiety (STAI), depression (CES-D), and quality of life in cancer patients (FACT-G) at randomization and 3 subsequent time points. RESULTS. Fifty-four men were randomized, and 16 of 18 (89%) of RRT and 15 of 18 (83%) of Reiki patients completed the intervention protocol. No statistically significant difference was found between the RRT, Reiki, and control groups on total scores for the STAI, CES-D, or FACT-G instruments at any time point. However, at the end of the intervention, significant improvement was found on the emotional well-being subscale of the FACT-G quality of life scale in the RRT group compared with the Reiki and control groups (P ¼ .01). In participants who were classified as ''anxious'' at baseline, statistically significant improvement occurred in the RRT group (P ¼ .02), and a positive trend was found in the Reiki group (P ¼ .10). CONCLUSIONS. This pilot study documented the feasibility of conducting a RCT of CAM therapies in men undergoing EBRx for prostate cancer. Relaxation response therapy improved emotional well being and eased anxiety in participants. Reiki therapy also had a positive effect in anxious patients. A larger study to verify and better define the benefits of these therapies in men with prostate cancer is warranted. Cancer 2011;117:96-102.
Background. Acupuncture is underutilized as an adjunct cancer therapy. The main study objectives were to determine the feasibility of administering acupuncture as palliative therapy to patients with advanced ovarian or breast cancer and to assess the effect on symptoms and quality of life (QOL). Methods. This study was a pilot, single-armed prospective clinical trial for patients with advanced cancer to receive 12 acupuncture sessions over 8 weeks with follow-up at weeks 9 and 12. Ambulatory patients with advanced ovarian or breast cancer were enrolled to receive treatments at an outpatient academic oncology center. Symptom severity was measured before and after each acupuncture session. A composite QOL assessment tool, consisting of validated instruments, was completed at 5 time points. Results. Forty patients enrolled in the study. Twenty-eight patients (70%; 95% confidence interval [CI] = 53%-83%) completed 4 weeks of treatment, and 26 patients (65%; 95% CI = 48%-79%) completed 8 weeks. Eight patients (20%) withdrew before receiving acupuncture, and 6 patients (15%) discontinued treatment early because of disease progression or scheduling demands. Among all 32 assessed patients, there was self-reported improvement immediately post-treatment in anxiety, fatigue, pain, and depression and significant improvement over time for patients with anxiety (P = .001) and depression (P = .02). Among patients experiencing baseline symptoms, there was improvement in anxiety (P = .001), fatigue (P = .0002), pain (P = .0002), and depression (P = .003). QOL measures of pain severity and interference, physical and psychological distress, life satisfaction, and mood states showed improved scores during treatment, with sustained benefit at 12 weeks. Conclusions. This pilot study demonstrates that an 8-week outpatient acupuncture course is feasible for advanced cancer patients and produces a measurable benefit that should be evaluated in controlled trials.
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