A Pilot Randomized Controlled Trial of Families Addressing Cancer Together for Parents With Cancer: Feasibility, Acceptability, and Preliminary Effects.
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OBJECTIVE: To evaluate the feasibility, acceptability, and preliminary efficacy of Families Addressing Cancer Together (FACT), a web-based, individually tailored, psychoeducational intervention for parents with cancer to improve illness-related communication with their minor children. METHODS: Parents with stage I-IV solid tumors who had children ages 3-17 were randomized to 6 weeks of FACT versus waitlist control. Feasibility was assessed by rates of recruitment and retention. Acceptability (primary outcome) was defined a priori as ≥ 75% of FACT participants rating FACT ≥ 12 (on an 18-point study-specific scale), and semi-structured interviews provided additional qualitative acceptability information. Generalized estimating equation methods were used to assess preliminary efficacy for communication self-efficacy, depression, and anxiety; Fisher's exact tests explored differences in individual communication beliefs and behaviors. RESULTS: Forty-eight approached patients enrolled (recruitment rate: 73%), 85% were retained through the post-intervention assessment, and 78% rated FACT as acceptable. In the FACT group compared to control, the modeled improvement in CSES scores from baseline to post-intervention was 9.5 versus 0 points (p = 0.004). FACT participants were more likely to have told their children that they have cancer (83.3% vs. 52.2%, p = 0.03) and felt more prepared to answer their children's questions about cancer (p = 0.02). Groups did not differ in depression or anxiety. CONCLUSIONS: FACT was feasible, acceptable, and demonstrated potential to improve parents' communication self-efficacy, beliefs, and behaviors. A large scale randomized controlled trial of FACT is needed to confirm these benefits and evaluate longer-term effects on psychological outcomes for parents with cancer and their children.