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
(2025) In Journal of Cancer Survivorship- Abstract
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... (More)
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).
(Less)
- author
- Winter, Julia ; Gasslander, Nils ; Rane, Gustaf ; Sundström, Felicia ; Björkhem-Bergman, Linda ; Hedman, Christel LU and Axelsson, Erland
- organization
- publishing date
- 2025
- type
- Contribution to journal
- publication status
- epub
- subject
- keywords
- Cancer survivors, Fear of recurrence, Feasibility studies, Proof of concept study, Telemedicine
- in
- Journal of Cancer Survivorship
- publisher
- Springer
- external identifiers
-
- pmid:41136825
- scopus:105019546521
- ISSN
- 1932-2259
- DOI
- 10.1007/s11764-025-01905-2
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © The Author(s) 2025.
- id
- c37b8057-6ab6-4c03-b34c-0df15319b2e7
- date added to LUP
- 2026-01-16 15:39:32
- date last changed
- 2026-01-19 14:34:37
@article{c37b8057-6ab6-4c03-b34c-0df15319b2e7,
abstract = {{<p>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).</p>}},
author = {{Winter, Julia and Gasslander, Nils and Rane, Gustaf and Sundström, Felicia and Björkhem-Bergman, Linda and Hedman, Christel and Axelsson, Erland}},
issn = {{1932-2259}},
keywords = {{Cancer survivors; Fear of recurrence; Feasibility studies; Proof of concept study; Telemedicine}},
language = {{eng}},
publisher = {{Springer}},
series = {{Journal of Cancer Survivorship}},
title = {{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}},
url = {{http://dx.doi.org/10.1007/s11764-025-01905-2}},
doi = {{10.1007/s11764-025-01905-2}},
year = {{2025}},
}