Logo: to the web site of Uppsala University

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. 

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

Objective: Fertility-related distress and sexual dysfunction following cancer is a major threat to quality of life in survivorship. Fex-Can 2.0 is an internet intervention developed to alleviate such problems among young adult (18-39 years) cancer survivors through provision of educational and behavior change content, self-management tools, and support. The study protocol of the Fex-Can 2.0 internal pilot study and randomized controlled trial (RCT) will be presented in detail.

Methods: The study will be performed in a parallel two-armed superiority RCT with an internal pilot phase. The primary objective is to determine the efficacy of the Fex-Can 2.0 intervention in terms of reduction of fertility-related distress and sexual dysfunction. The internal pilot study will assess feasibility of the study, determined according to pre-specified progression criteria on recruitment, attrition, adherence and resources. Primary and secondary outcomes will be assessed at baseline, at end of the intervention, and 12 weeks after end of the program. Primary outcomes are fertility-related distress (RCAC) and sexual function and satisfaction (PROMIS® SexFS v2.0).

Conclusion and implications: Findings from this study will determine the feasibility and efficacy of the Fex-Can 2.0 intervention. As no intervention is available for use among health care providers of young cancer patients in Sweden today, the Fex-Can 2.0 may, if proven efficacious, have significant clinical implications through improving care provided to young adults diagnosed with cancer.

ObjectiveTo test the efficacy of a web-based psychoeducational intervention, Fex-Can Sex, in reducing sexual dysfunction in young adults with cancer.

MethodsThis randomized controlled trial evaluated a 12-week web-based self-help intervention. Young adults aged 19–40 who reported sexual dysfunction 1.5 years after cancer diagnosis were drawn from a population-based cohort. Participants were randomized to an intervention group (IG, n = 72) or a control group (CG, n = 66) that solely received standard care. Primary outcome was assessed by a domain of the Patient Reported Outcome Measures Information Systems® SexFS: “Satisfaction with sex life.” Secondary outcomes included additional SexFS domains, body image (BIS), emotional distress (HADS), health-related quality of life (EORTC QLQ-C30), and self-efficacy related to sex. Surveys were completed at baseline, post-intervention, and three months later. Effects of the intervention were tested with t-tests, and linear mixed models (LMMs), including intention-to-treat and subgroup analyses. Additionally, the IG was asked about their experiences of the program with study-specific questions.

ResultsThere were no differences in primary or secondary outcomes between the IG and the CG at post-intervention. Subgroup analyses showed that individuals with greater sexual problems at baseline improved over time, regardless of group allocation. Participants spent a mean time of 20.7 min on the program. The study-specific items showed that the majority of participants in the IG appreciated the program and would recommend it to others.

ConclusionThe Fex-Can Sex intervention did not show effect on primary and secondary outcomes. Adherence to the intervention was low, and future interventions are recommended to include more interactive components to enhance usage.

Clinical trial registrationThe trial was registered on 25 January, 2016 (trial number: 36621459).

Objective: Patient and public involvement and engagement (PPIE) in research is essential in developing relevant and effective complex interventions for health. The aim is to present the planned process of patient involvement in the development of an internet intervention targeting fertility distress and sexual dysfunction among young adults following cancer.Methods: The present PPIE project is part of the Fertility and Sexuality following Cancer (Fex-Can) project, aiming to alleviate fertility distress and sexual dysfunction among young adult cancer survivors. Approximately 10 young adults (18-39 years) with experience of cancer are being recruited via patient advocacy organizations, social media, and oncology-and hematology clinics to be part of a co-research group. The collaboration will consist of 1-day meetings during which specific topics of the intervention and study design will be discussed and workshopped, including content and structure of the intervention program, recruitment strategies and patient information, as well as collaborative analysis of study results.Results: Evaluation of perceived impact of activities will be assessed using impact logs, and interviews will be conducted to examine the process and experiences of PPIE in the Fex-Can project.Conclusion and implications: Involvement of members of the target group in the development of the Fex-Can 2.0 intervention can facilitate the relevance and potential impact of our internet intervention, as well as empower individuals with lived experiences, and limit research waste.

Objective: The study aimed to investigate acceptability of a clinical trial, the Fex-Can Sex intervention, a web-based program targeting sexual dysfunction following cancer.

Methods: Young adults (aged 19–40) who reported sexual dysfunction 1.5 years after a cancer diagnosis were drawn from a population-based cohort and invited to a two-armed randomized controlled trial. Participants in the intervention group (n=572) participated in a 12-week web-based psychoeducational self-help program. The program was guided by self-determination theory, and developed in collaboration with former patients with cancer. Apart from testing the efficacy of the intervention, study-specific items were used to assess experiences of the program’s different parts. Additionally, the intervention group answered open-ended questions about their thoughts of the program and/or sexuality which were analyzed with thematic analysis.

Results: The post-intervention items were completed by 56 participants (78%). The majority appreciated the program (73%) and would recommend it to others (91%), and 18% reported that their sexual problems had improved. Analysis of the participants’ experiences resulted in four main themes: Perceived benefits, Barriers to participation, Not for me, and Suggestions for the future.

Conclusion and implications: Participants’ experiences of the program were generally positive, supporting acceptability. Revision of the program to Fex-Can 2.0 is currently ongoing.

Objective: This study sought to investigate interactive participation and content of a moderated discussion forum within a web-based psychoeducational intervention aimed at alleviating sexual dysfunction and fertility distress in young adults diagnosed with cancer.

Methods: The study is part of the Fex-Can Young Adult randomized controlled trial (RCT), in which young adults with self-reported sexual dysfunction or fertility distress were invited to participate. This study focuses on RCT participants that were randomized into the intervention condition. Sociodemographics and clinical characteristics of intervention participants and level of activity in the intervention were analyzed with descriptive statistics and compared between subgroups (“high” and “low” activity participants). Inductive qualitative thematic analysis was used to analyze the posts in the discussion forum.

Results: Of 135 intervention participants, 24% met the criteria for high activity participation. There were no statistically significant differences found in terms of clinical and sociodemographic characteristics between high and low activity participants. Ninety-one participants (67%) accessed the discussion forum, and 19 (14%) posted at least once. Posters shared intimate details of their experiences of sexuality and fertility following cancer. The thematic analysis of posts resulted in four themes: fertility fears, perceptions of the changed body, missing out on life, and importance of support and information.

Conclusions: While a smaller proportion of participants posted in the discussion forum, a majority spent time reading posts (lurkers). Participants posting in the forum shared experiences of intimate relationships, body image, parenthood concerns, and support needs. The discussion forum was used by a majority of intervention participants, and provided appreciated support for those who posted in the forum. We therefore recommend similar interventions to include this opportunity for interaction and communication.