Trial reportBMC medicine2026
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.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
backgroundFear 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.
methodsThe 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.
resultsBased 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.
conclusionsThis 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 registrationChiCTR2300069395. Registered on 15 March 2023.
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