OBJECTIVE: This pilot project evaluated the acceptability and estimated the effect size of a tailored multidisciplinary quality of life (MQOL) intervention for men who have biochemical recurrence of prostate cancer. METHODS:Participants included 57 men with localized prostate cancer with biochemical recurrence (Median=76 years; 89% White). Participants were randomized to wait list control which offered the intervention upon conclusion of the study (n=27) or to an eight-session group-based, MQOL (n=30) intervention. Assessments were completed at baseline, end of treatment, and 6 months post-treatment. RESULTS:MQOL was acceptable as indicated by favorable participant retention (100% retained), treatment compliance (97% attended > 6 treatment sessions), and high ratings of helpfulness (80% rated helpfulness > 4 on 5-point scale). MQOL had a favorable impact on the mental health composite score of the Short Form-36 at the end of treatment but not at 6 months (effect size=0.52 and -0.04); health-related QOL as measured by the Functional Assessment of Cancer Therapy-Prostate at the end of treatment and 6 months (effect size=0.14 and 0.10); and prostate cancer specific anxiety as measured by the Memorial Anxiety Scale for Prostate Cancer at the end of treatment and 6 months (effect size=0.45 and 0.23). CONCLUSIONS: This pilot project provides preliminary data supporting the premise that a tailored behaviorally based MQOL intervention for men with biochemical recurrence of prostate cancer is acceptable to men and might reduce prostate cancer specific anxiety and enhance QOL. Further research examining the efficacy of this intervention in a larger randomized trial is warranted.
RCT Entities:
OBJECTIVE: This pilot project evaluated the acceptability and estimated the effect size of a tailored multidisciplinary quality of life (MQOL) intervention for men who have biochemical recurrence of prostate cancer. METHODS:Participants included 57 men with localized prostate cancer with biochemical recurrence (Median=76 years; 89% White). Participants were randomized to wait list control which offered the intervention upon conclusion of the study (n=27) or to an eight-session group-based, MQOL (n=30) intervention. Assessments were completed at baseline, end of treatment, and 6 months post-treatment. RESULTS:MQOL was acceptable as indicated by favorable participant retention (100% retained), treatment compliance (97% attended > 6 treatment sessions), and high ratings of helpfulness (80% rated helpfulness > 4 on 5-point scale). MQOL had a favorable impact on the mental health composite score of the Short Form-36 at the end of treatment but not at 6 months (effect size=0.52 and -0.04); health-related QOL as measured by the Functional Assessment of Cancer Therapy-Prostate at the end of treatment and 6 months (effect size=0.14 and 0.10); and prostate cancer specific anxiety as measured by the Memorial Anxiety Scale for Prostate Cancer at the end of treatment and 6 months (effect size=0.45 and 0.23). CONCLUSIONS: This pilot project provides preliminary data supporting the premise that a tailored behaviorally based MQOL intervention for men with biochemical recurrence of prostate cancer is acceptable to men and might reduce prostate cancer specific anxiety and enhance QOL. Further research examining the efficacy of this intervention in a larger randomized trial is warranted.
Authors: Rebecca R Turner; Liz Steed; Helen Quirk; Rosa U Greasley; John M Saxton; Stephanie Jc Taylor; Derek J Rosario; Mohamed A Thaha; Liam Bourke Journal: Cochrane Database Syst Rev Date: 2018-09-19