Feasibility and preliminary efficacy of an art-making program to manage fear of cancer recurrence (AM-I-FCR) in lung cancer patients: a randomized controlled pilot study.

[BACKGROUND] Fear of cancer recurrence (FCR) imposes a significant psychological and physical burden on cancer patients. Art-making interventions may offer a novel approach to alleviating FCR. This study aimed to develop an art-making program (AM-I-FCR) and assess its feasibility and preliminary effects on FCR in lung cancer patients.

[METHODS] The AM7-I-FCR was developed and evaluated via intervention mapping from March to December 2023. Step 1 (needs assessment) involved qualitative interviews. Step 2 (setting objectives) included translation and matrix creation. Step 3 (program design) involved a theoretical framework and a systematic review. Step 4 (program production) conducted expert meetings and collected patient feedback. Step 5 (implementation) and Step 6 (program evaluation) involved a pilot-randomized controlled trial (RCT) from August to December 2023 at a tertiary hospital in Fuzhou, China. The participants were randomized to receive either standard care or AM-I-FCR plus standard care. Data were collected at baseline, midpoint, and post-intervention and analyzed using intention-to-treat analysis and generalized linear mixed models. Feasibility was assessed by participation rates, satisfaction, and adverse events. Fidelity was evaluated via standardized checklist, supervision meetings, audio recordings, and qualitative interviews.

[RESULTS] Based on the first four steps, AM-I-FCR was developed successfully. The pilot-RCT including 60 patients (30 per group), with 28 valid cases per group, revealed significantly lower FCR severity (95% CI, 0.606 ~ 2.994, p < 0.001), anxiety (95% CI, - 2.888 ~ - 0.712, p < 0.05), depression (95% CI - 3.587 to - 1.147, p < 0.05), and illness perceptions (95% CI, 0.079 ~ 4.654, p < 0.001), along with improved confrontation (95% CI, - 3.908 ~ - 1.425, p < 0.001) and emotional quality of life (QOL) (95% CI, - 2.674 ~ - 0.859, p < 0.001) in the intervention group. No significant differences were noted in avoidance or other QOL dimensions (p > 0.05). The intervention was feasible, with no adverse events. The interviews emphasized emotional release and self-exploration, demonstrating high fidelity.

[CONCLUSIONS] This study successfully developed the AM-I-FCR, which showed encouraging feasibility and acceptability and preliminarily reduced FCR severity, anxiety, and depression while improving confrontation, illness perceptions, and emotional well-being.

[TRIAL REGISTRATION] ChiCTR2300069395. Registered on 15 March 2023.