Toshimi Takano1,2, Ayako Matsuda3, Noriko Ishizuka4, Yukinori Ozaki5, Koichi Suyama5,6, Yuko Tanabe5, Yuji Miura5, Eisuke Matsushima4. 1. Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan. takano@toranomon.gr.jp. 2. Section of Liaison Psychiatry and Palliative Medicine, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan. takano@toranomon.gr.jp. 3. Department of Hygiene and Public Health, School of Medicine, Teikyo University, Tokyo, Japan. 4. Section of Liaison Psychiatry and Palliative Medicine, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan. 5. Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan. 6. Kumamoto University Hospital Cancer Center, Kumamoto, Japan.
Abstract
BACKGROUND: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. METHODS:From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). RESULTS: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continuedcytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. CONCLUSIONS:Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, a post-hoc subset analysis suggested that the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000012842 . Registered 14 January 2014.
RCT Entities:
BACKGROUND: A self-help workbook is expected to support cancerpatients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. METHODS: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). RESULTS: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. CONCLUSIONS: Self-help workbook intervention was feasible in cancerpatients receiving chemotherapy. Although the effect of the intervention was limited, a post-hoc subset analysis suggested that the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000012842 . Registered 14 January 2014.
Entities:
Keywords:
Breast cancer; Chemotherapy; Colorectal cancer; Gastric cancer; Lung cancer; Patient-reported outcome; Psycho-oncology; Psychosocial support system
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