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An internet-delivered psychoeducational intervention (Fex-Can 2.0) targeting fertility-related distress and sexual dysfunction in young adults diagnosed with cancer: Study protocol of a randomized controlled trial with an internal pilot phase
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.ORCID iD: 0000-0002-4555-1274
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Cardiovascular Psychology.ORCID iD: 0000-0002-1591-7407
College of Health, Oregon State University, Corvallis, Oregon, United States of America..
Department of Supportive Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, United States of America, Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, United States of America.
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2025 (English)In: PLOS ONE, E-ISSN 1932-6203, Vol. 20, no 4, article id e0322368Article in journal (Refereed) Published
Abstract [en]

Background

While previous literature has continuously demonstrated the negative effects of cancer and its treatment on fertility and sexuality, evidence-based interventions to alleviate fertility-related distress and sexual dysfunction are lacking. This study protocol describes the internal pilot study and randomized controlled trial of an internet-delivered psychoeducational intervention: Fex-Can 2.0. The primary objective is to determine efficacy of Fex-Can 2.0 in terms of reduction of fertility-related distress and sexual dysfunction at end of the 12-week intervention. The internal pilot study will assess feasibility of the study, determined according to pre-specified progression criteria and individual interviews.

Methods

The study has a randomized controlled design, with an internal pilot phase. The intervention group will receive Fex-Can 2.0, consisting of psychoeducational- and behavior change content. The control group will be allocated to standard care. Primary outcomes are fertility-related distress (RCAC) and sexual function and satisfaction (PROMIS SexFS Brief Sexual Profile). Secondary outcomes include body image (BIS), emotional distress (HADS), health-related quality of life (EORTC QLQ-C30), need satisfaction and frustration scale (NSFS), fertility- and sex-related knowledge, and self-efficacy related to fertility and sex life. Outcomes will be assessed at baseline, directly after the intervention, and 12 weeks later. During the internal pilot, data on trial recruitment, data collection, drop out, and adherence will be collected to assess feasibility. Semi-structured interviews will be conducted to further assess acceptability of Fex-Can 2.0.

Conclusions

This randomized controlled trial aims to evaluate whether Fex-Can 2.0 is superior to standard care, in terms of reducing fertility-related distress and sexual dysfunction in young adults diagnosed with cancer. If proven efficacious, the Fex-Can 2.0 intervention may be a valuable resource in health care, with the potential to significantly improve the care of young adults experiencing fertility-related distress and/or sexual dysfunction following cancer.

Trial registration

ClinicalTrials.gov ISRCTN18040643

Place, publisher, year, edition, pages
Public Library of Science (PLoS), 2025. Vol. 20, no 4, article id e0322368
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-557408DOI: 10.1371/journal.pone.0322368ISI: 001488708100037PubMedID: 40300010Scopus ID: 2-s2.0-105003974066OAI: oai:DiVA.org:uu-557408DiVA, id: diva2:1961480
Part of project
Web-based treatment of fertility-related distress and sexual problems after cancer – a randomized controlled pilot trial testing the Fex-Can 2.0 program, Swedish Research Council
Funder
Swedish Research Council, 2022-00832The Cancer Research Funds of Radiumhemmet, 161272Swedish Cancer Society, 222311PjForte, Swedish Research Council for Health, Working Life and Welfare, 2019-00838Available from: 2025-05-27 Created: 2025-05-27 Last updated: 2026-01-18Bibliographically approved
In thesis
1. Internet-delivered interventions for sexual and reproductive health following cancer: The Fex-Can Young Adult project
Open this publication in new window or tab >>Internet-delivered interventions for sexual and reproductive health following cancer: The Fex-Can Young Adult project
2026 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

This thesis is embedded within the Fex-Can Young Adult research project and consists of five papers. The overall aim was to develop and evaluate internet-delivered interventions targeting sexual problems and fertility-related distress following a cancer diagnosis, with the ultimate goal of improving the quality of survivorship among individuals diagnosed with cancer during young adulthood (18-39 years).

Paper I reported findings from a randomized controlled trial evaluating the efficacy of the Fex-Can Sex program in alleviating sexual dysfunction 1.5 years following a cancer diagnosis during young adulthood. No significant effects of the program were demonstrated, and participant activity in the intervention was limited. 

Paper II explored interactive activity and the content of discussions forum posts within the Fex-Can Sex and Fex-Can fertility programs. A limited proportion of participants met criteria for high level activity. Four themes were constructed through thematic analysis of the discussion forum posts: Fertility fears, Perceptions of the changed body, Missing out on life, and Importance of support and information

Paper III presented the internal pilot trial and randomized controlled trial of the Fex-Can 2.0 intervention, which was designed to alleviate sexual problems and fertility-related distress among individuals diagnosed with cancer during young adulthood. 

Paper IV presented the collaboration between patient research partners and researchers in the refinement and further development of the Fex-Can intervention. Using qualitative content analysis for analysis of multimodal data (impact log information, field notes, individual interviews), three main categories were constructed: Collaborative working process, Group atmosphere and Concrete impact

Paper V investigated changes in perceptions of the body during the first five years following a cancer diagnosis in young adulthood. Over half of female and one-fourth of male participants reported body image disturbance at 1.5 years post-diagnosis, with significant improvements in body image observed over time among males and among females diagnosed with breast cancer or lymphoma. 

The work presented in this thesis contributes to existing research by providing insight into the sexual and reproductive health of young adults diagnosed with cancer, and by informing future research aimed at refining and evaluating internet-delivered interventions. 

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2026. p. 112
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 2227
Keywords
Cancer survivorship, Sexual and reproductive health, Body image, Young adults, Internet-delivered interventions, Patient and public involvement, Complex interventions
National Category
Cancer and Oncology Nursing
Research subject
Medical Science
Identifiers
urn:nbn:se:uu:diva-575649 (URN)978-91-513-2722-8 (ISBN)
Public defence
2026-03-06, Lecture Hall IV, University Main Building, Biskopsgatan 3, Uppsala, 13:15 (English)
Opponent
Supervisors
Available from: 2026-02-12 Created: 2026-01-18 Last updated: 2026-02-12

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Skog, RebeccaOlsson, ErikLampic, ClaudiaWettergren, Lena

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