PURPOSE Fear of cancer recurrence (FCR) is a common distressing condition. We investigated the efficacy of smartphone problem-solving therapy and behavioral activation applications in breast cancer survivors. METHODS This was a decentralized randomized trial. Participants were disease-free breast cancer survivors age 20-49 years who were randomly assigned to the smartphone-based intervention or waitlist control. Both groups received treatment as usual. The control group could access the smartphone apps during weeks 8-24. The intervention comprised smartphone problem-solving therapy and behavioral activation apps. The primary end point was the Concerns About Recurrence Scale at week 8. Secondary outcomes included the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), the Hospital Anxiety and Depression Scale (HADS), the Short-form Supportive Care Needs Survey (SCNS-SF34), and the Posttraumatic Growth Inventory at weeks 8 and 24 (trial registration: UMIN-CTR: UMIN000031140). RESULTS The intervention group included 223 participants, and the control group included 224 participants. Primary outcome data were obtained for 444 participants, and 213 participants in the intervention arm completed the week 24 assessment. The intervention group had statistically greater improvements than controls at week 8 on the Concerns About Recurrence Scale (difference –1.39; 95% CI, –1.93 to –0.85; P < .001), FCRI-SF (difference –1.65; 95% CI, –2.41 to –0.89; P < .001), HADS depression (difference –0.49; 95% CI, –0.98 to 0; P < .05), and SCNS-SF34 psychological domain (difference –1.49; 95% CI, –2.67 to –0.32; P < .05). These scores at week 24 were not statistically significant compared with week 8 although the HADS depression score at week 24 was significantly reduced ( P = .03). CONCLUSION Novel smartphone psychotherapy offers a promising way to reduce FCR given the large number of survivors and a limited number of therapists to competently conduct psychotherapy.

BackgroundSarcopenia is generally complicated with patients with chronic heart failure (CHF) and its presence negatively affects the course of heart failure, however effective nutritional intervention had not been elucidated yet. The primary objective of this study is to explore whether the addition of a branched-chain amino acid (BCAA) preparation for cardiac rehabilitation (CR) of patients with CHF further improves cardiopulmonary functions, skeletal muscle functions, and metabolism in comparison with conventional CR.MethodsThis is a randomized, parallel-group comparative study. The elderly patients that were participated in CR and complicated with left ventricular systolic or diastolic dysfunction are randomized into two groups, CR + BCAA and CR. 20 weeks later, the second randomization is performed, which divide subjects into two groups with and without BCAA intervention without CR. Primary outcome measure is the rate of change of the anaerobic threshold workload from baseline to post-intervention. Secondary outcome include parameters of exercise capacity, cardiac function and psychological status.DiscussionIn the current study the effect of a promising new intervention, BCAA, will be assessed to determine whether its addition to CR improve exercise capacity in patients with heart failure, who are generally complicated with sarcopenia.Trial registrationThis clinical trial was registered with the University Hospital Medical Information Network—Clinical Trials Registry (UMIN–CTR; JPRN–UMIN R000022440).

Phase 3 randomized trial of topical steroid versus placebo for prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiation,

BackgroundWorkers in Japan are not sufficiently active; however, it remains unclear how their leisure-time physical activity habits may be developed. This cross-sectional study investigated the relationship of age- and intensity-specific leisure-time physical activity in youth to adulthood leisure-time physical activity habits among Japanese workers.MethodsIn 2012, 968 workers (333 males and 635 females) from three companies and six hospitals in the Tokai region of Japan agreed to complete and submit a self-administered questionnaire. Intensity-specific leisure-time physical activity at ages 12 and 20 years was assessed retrospectively, and workers’ current participation in regular leisure-time physical activity was assessed as an outcome measure. Multivariable-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using logistic regression analysis.ResultsMean ages for males and females were 40 and 37 years, respectively. Strenuous leisure-time physical activity at age 12 years was significantly positively associated with adulthood participation in leisure-time physical activity among male workers [adjusted OR (95% CI) = 2.29 (1.02, 5.14)]. Additionally, both strenuous and moderate physical activity at age 20 years was significantly positively associated with participation in regular leisure-time physical activity in adulthood among males and females.ConclusionsOur results suggest that some leisure-time physical activity in youth may predict adult workers’ participation in regular leisure-time physical activity in Japan. Encouragement of leisure-time physical activity in youth could therefore be an effective measure to develop adult leisure-time physical activity habits among workers.

BackgroundTo date, the clinical benefit of topical steroid use has only been demonstrated for radiation dermatitis induced by 50–60 Gy irradiation in breast cancer. However, these agents are also often used clinically for the control of radiation dermatitis induced by high-dose (>60Gy) irradiation with chemotherapy in head and neck cancer. Despite this, the prophylactic efficacy of topical steroids for radiation dermatitis induced by high-dose irradiation is still unclear.The aim of this study is to clarify the benefit of topical steroids in basic nursing care for radiation dermatitis induced by chemoradiotherapy in patients with head and neck cancer.MethodsThe study is being conducted as a multicenter 2-arm randomized double-blinded placebo-controlled Phase 3 trial in Japan. The study was started in May 2017, with participant enrollment between May 2017 and April 2019.Patients scheduled to receive definitive or postoperative chemoradiotherapy for head and neck cancer are eligible for enrollment. All patients will receive chemoradiotherapy, consisting of single agent CDDP and 70-Gy irradiation. Bilateral neck irradiation is mandatory.Supportive care for radiation dermatitis will consist of basic nursing care with topical steroid or placebo. When radiation dermatitis grade 1 is seen or total radiation dose reaches 30 Gy, minimally required intervention will be started as a first step.If radiation dermatitis worsens to grade 2, the irradiated area will be covered with a moderately absorbent surgical pad and steroid or placebo topical cream.The primary endpoint is a comparison of the proportion of patients with ≥ grade 2 radiation dermatitis by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.Ethical approval has been obtained from all participating sites. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.DiscussionEvidence supporting the benefit of adding topical steroids in general nursing care for radiation dermatitis induced by high-dose irradiation with chemotherapy is insufficient. This trial aims to clarify the clinical benefit of topical steroid for radiation dermatitis induced by high-dose irradiation with chemotherapy. The trial is ongoing and is currently recruiting.Trial registration numberUMIN000027161. Protocol version 3.0, 18 April 2017.