Journal of cancer survivorship : research and practice · 2025
Proof-of-concept for a randomized factorial design strategy to build a complex online support program for cancer survivors with psychiatric symptoms: the IN-FACT-0 feasibility trial.
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Winter Julia, Gasslander Nils, Rane Gustaf, Sundström Felicia, Björkhem-Bergman Linda, Hedman Christel, Axelsson Erland
Аннотация
PURPOSE: Internet-delivered cognitive behavioral therapies and lifestyle interventions are promising for reducing psychiatric symptoms in cancer survivors, but little is known about the contribution of specific treatment components to observed effects. A randomized factorial trial could allow for evaluation of the unique contribution of treatment components to overall treatment effects. The IN-FACT-0 trial assessed the feasibility of such an approach for building an online support program for reducing long-term psychiatric symptoms in cancer survivors.
METHODS: In a full factorial experiment, 40 survivors of breast, testicular, or thyroid cancer with clinically significant depressive symptoms, anxiety, or fear of recurrence were randomized to combinations of three treatment components: (i) behavioral activation, (ii) systematic exposure, and (iii) healthy lifestyle promotion. All groups, including a control group, received rudimentary support and kept a symptom diary.
RESULTS: On average, therapists rated the feasibility of the study design 9 on a scale from 0 ("not feasible at all") to 10 ("fully feasible"). The Credibility/Expectancy Scale mean was 36.6 (SD = 8.2). Participants initiated a mean of 6.1 (SD = 2.2, median = 7) out of 8 modules, and 90% (36/40) completed the post-treatment assessment. The mean Client Satisfaction Questionnaire score was 24.3 (SD = 5.7). One adverse event each was reported by 2/36 (6%) participants. No event was serious. The mean reduction was large in depressive symptoms (d = 0.83) and moderate in general anxiety (d = 0.55) and fear of recurrence (d = 0.54).
CONCLUSIONS: This randomized factorial trial design was feasible.
IMPLICATIONS FOR CANCER SURVIVORS: This trial design may be used to develop effective, evidence-based interventions for cancer survivors with psychiatric symptoms.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06046573 (registered 2023-09-21).
METHODS: In a full factorial experiment, 40 survivors of breast, testicular, or thyroid cancer with clinically significant depressive symptoms, anxiety, or fear of recurrence were randomized to combinations of three treatment components: (i) behavioral activation, (ii) systematic exposure, and (iii) healthy lifestyle promotion. All groups, including a control group, received rudimentary support and kept a symptom diary.
RESULTS: On average, therapists rated the feasibility of the study design 9 on a scale from 0 ("not feasible at all") to 10 ("fully feasible"). The Credibility/Expectancy Scale mean was 36.6 (SD = 8.2). Participants initiated a mean of 6.1 (SD = 2.2, median = 7) out of 8 modules, and 90% (36/40) completed the post-treatment assessment. The mean Client Satisfaction Questionnaire score was 24.3 (SD = 5.7). One adverse event each was reported by 2/36 (6%) participants. No event was serious. The mean reduction was large in depressive symptoms (d = 0.83) and moderate in general anxiety (d = 0.55) and fear of recurrence (d = 0.54).
CONCLUSIONS: This randomized factorial trial design was feasible.
IMPLICATIONS FOR CANCER SURVIVORS: This trial design may be used to develop effective, evidence-based interventions for cancer survivors with psychiatric symptoms.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06046573 (registered 2023-09-21).