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Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors
Kim SH, Shin MS, Lee HS, Lee ES, Ro JS, Kang HS, Kim SW, Lee WH, Kim HS, Kim CJ, Kim J, Yun YH
Oncology Nursing Forum 2011 Mar;38(2):E97-E106
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE/OBJECTIVES: To investigate the feasibility and preliminary effects of a simultaneous stage-matched exercise and diet (SSED) intervention in breast cancer survivors. DESIGN: Randomized, controlled trial. SETTING: Oncology outpatient treatment clinics at the National Cancer Center in South Korea. SAMPLE: 45 women with breast cancer who completed their cancer therapy. METHODS: Participants were assigned to the SSED intervention group (n = 23) or a control group (n = 22). Participants in the SSED group received a 12-week individualized intervention promoting prescribed exercise and a balanced diet through stage-matched telephone counseling and a workbook. MAIN RESEARCH VARIABLES: Program feasibility, behavioral outcomes (stage of motivational readiness for exercise and diet, physical activity, and diet quality), and quality-of-life (QOL) outcomes (functioning and global QOL, fatigue, anxiety, and depression). FINDINGS: Participant evaluations of the SSED intervention indicated that it was feasible and acceptable. All women felt that the overall intervention contents were appropriate, and 95% believed that the intervention helped to promote healthy behaviors. Objective data also supported the SSED intervention's feasibility (ie, 91% completed the trial and 100% of intervention calls were received). When compared to control, the SSED intervention group showed significantly greater improvement in motivational readiness for exercise and diet, emotional functioning, fatigue, and depression. CONCLUSIONS: Preliminary results suggest that the SSED intervention delivered via telephone counseling and workbook is feasible and beneficial for positive behavioral and QOL outcomes. IMPLICATIONS FOR NURSING: Nurse-led lifestyle interventions may improve QOL for cancer survivors.

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