A phase II multicentered, single-blind, randomized, controlled trial of the XXXX self-management program.

@entity1 @entity73 @entity64
BACKGROUND AND PURPOSE: The benefits of chronic disease self-management programs for @entity64 survivors are uncertain because individuals with @entity73 have been excluded from previous research. We undertook a phase II randomized controlled trial to determine whether a self-management program designed for survivors (SSMP; 8 weeks) was safe and feasible compared to standard care (control) or a generic self-management program (generic; 6 weeks). METHODS: @entity64 survivors were recruited from 7 South Australian hospitals via a letter or indirectly (eg, newspapers). Eligible @entity1 were randomized at a 1:1:1 ratio of 50 per group. Primary outcomes were recruitment, participation, and @entity1 safety. Secondary outcomes were positive and active engagement in life using the Health Education Impact Questionnaire and characteristics of quality of life and mood at 6 months from program completion. RESULTS: Of 315 @entity1 screened, 149 were eligible and 143 were randomized (48 SSMP, 47 generic, 48 control); mean age was 69 years (SD, 11) and 59% were female. Demographic features were similar between groups and 41% had severe @entity73 ; 57% accessed the interventions, with 52% SSMP and 38% generic completing >50% of sessions (P=0.18). Thirty-two @entity1 reported adverse events (7 control, 12 generic, 13 SSMP; P=0.3; 34% severe); however, none was attributable to the interventions. Potential benefits for improved mood were found. CONCLUSIONS: SSMP was safe and feasible. Benefits of the @entity64 -specific program over the generic program included greater participation and completion rates. An efficacy trial is warranted given the forecast growth in the @entity64 population and improved survival trends.
