OBJECTIVE: To determine whether a telephone counseling program can improve psychosocial outcomes among breast cancer patients post-treatment. METHODS: A randomized trial was conducted involving 21 hospitals and medical centers, with assessments (self-administered questionnaires) at baseline, 12 and 18 months post-enrollment. Eligibility criteria included early stage diagnosis, enrollment during last treatment visit, and the ability to receive the intervention in English. Endpoints included distress (Impact of Event Scale), depression (Center for Epidemiologic Studies Depression Scale), and two study-specific measures: sexual dysfunction and personal growth. The control group (n=152) received a resource directory for breast cancer; the intervention group (n=152) also received a one-year, 16 session telephone counseling program augmented with additional print materials. RESULTS: Significant intervention effects were found for sexual dysfunction at 12 (p=0.03) and 18 months (p=0.04) and personal growth (12 months: p=0.005; 18 months: p=0.03). No differences by group were found in mean scores for distress and depression, with both groups showing significant improvement at 12 and 18 months (all p values for within-group change from baseline were <or=0.003). However, when dichotomized at cutpoints suggestive of the need for a clinical referral, the control group showed virtually no change at 18 months, whereas the intervention group showed about a 50% reduction in both distress (p=0.07) and depression (p=0.06). CONCLUSIONS:Telephone counseling may provide a viable method for extending psychosocial services to cancer survivors nationwide. (c) 2010 John Wiley & Sons, Ltd.
RCT Entities:
OBJECTIVE: To determine whether a telephone counseling program can improve psychosocial outcomes among breast cancerpatients post-treatment. METHODS: A randomized trial was conducted involving 21 hospitals and medical centers, with assessments (self-administered questionnaires) at baseline, 12 and 18 months post-enrollment. Eligibility criteria included early stage diagnosis, enrollment during last treatment visit, and the ability to receive the intervention in English. Endpoints included distress (Impact of Event Scale), depression (Center for Epidemiologic Studies Depression Scale), and two study-specific measures: sexual dysfunction and personal growth. The control group (n=152) received a resource directory for breast cancer; the intervention group (n=152) also received a one-year, 16 session telephone counseling program augmented with additional print materials. RESULTS: Significant intervention effects were found for sexual dysfunction at 12 (p=0.03) and 18 months (p=0.04) and personal growth (12 months: p=0.005; 18 months: p=0.03). No differences by group were found in mean scores for distress and depression, with both groups showing significant improvement at 12 and 18 months (all p values for within-group change from baseline were <or=0.003). However, when dichotomized at cutpoints suggestive of the need for a clinical referral, the control group showed virtually no change at 18 months, whereas the intervention group showed about a 50% reduction in both distress (p=0.07) and depression (p=0.06). CONCLUSIONS: Telephone counseling may provide a viable method for extending psychosocial services to cancer survivors nationwide. (c) 2010 John Wiley & Sons, Ltd.
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