Internet-delivered treatment for fertility distress and sex problems following cancer
| ISRCTN | ISRCTN18040643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18040643 |
- Submission date
- 10/12/2024
- Registration date
- 12/12/2024
- Last edited
- 11/08/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
About 2,300 young adults (aged 18-39 years) are diagnosed with cancer in Sweden every year. Cancer in young adulthood may interfere with important life goals such as establishing romantic relationships and family building, and many young adults experience significant fertility distress and sexual problems as a result of cancer. There’s limited support available for such problems today, and few interventions have targeted the needs of the young adult cancer population. The present study aims to evaluate the efficacy of an internet-delivered intervention aiming to alleviate fertility-related distress and sexual dysfunction among young adults following cancer.
Who can participate?
Young adults (aged 18-39 years) diagnosed with any type of cancer in the past 5 years and experiencing fertility-related distress and sexual dysfunction
What does the study involve?
Participants in the present study will be randomly allocated to one of two groups: an intervention group, which will receive access to the internet-delivered, guided self-help intervention Fex-Can 2.0, or a control group, allocated to standard care. Following randomization, participants allocated to the intervention group will be invited to participate in an individual start-up session with a research team member. During this session, a set of modules from the Fex-Can 2.0 intervention will be recommended based on the individual participant's needs and problems. Subsequently, participants will receive access to their modules and follow their own personal set of modules throughout the intervention program, which is delivered over a period of 12 weeks. Modules included in the Fex-Can 2.0 intervention include educational and behavior change components such as multimedia, interactive components (self-monitoring, quizzes, exercises) and a moderated peer discussion forum. Participants will further receive personalized feedback on completing exercises. Participants allocated to the control group will receive standard care and follow-up. Participants will be requested to respond to questionnaires at baseline (before randomization), at mid-intervention (week 6), directly at the end of the intervention, and 12 weeks later.
What are the possible benefits and risks of participating?
Intervention group participants will receive information, support and strategies to manage fertility-related distress and sexual problems. If proven to be effective, Fex-Can 2.0 will be of great help for young adult cancer patients, as well as for health care providers, as no such intervention is available in Swedish cancer care today.
There are no medical risks of participating in the study. However, some participants may feel that questions about fertility and sexuality are intimate and sensitive. Further, some participants may be reminded of difficult experiences and/or consequences of cancer and cancer treatment, and may further detect and worry about new problems that haven’t thought about previously.
Where is the study run from?
Uppsala University (Sweden)
When is the study starting and how long is it expected to run for?
January 2023 to December 2030
Who is funding the study?
1. Swedish Research Council (dnr: 2022-00832)
2. Forte (dnr: 2019-00838)
3. Swedish Cancer Society (dnr: 222311Pj)
4. Cancer Research Funds of Radiumhemmet (dnr: 161272)
Who is the main contact?
1. Lena Wettergren, lena.wettergren@uu.se
2. Claudia Lampic, claudia.lampic@umu.se
Contact information
Scientific, Principal Investigator
BMC, Husargatan 3
Uppsala
751 22
Sweden
 ORCID ID |
0000-0003-1279-2191 |
|---|---|
| Phone | +46 (0)18-471 66 16 |
| lena.wettergren@uu.se |
Scientific, Principal Investigator
Mediagränd 14
Umeå
901 87
Sweden
| ORCID ID |
0000-0002-1739-4486 |
|---|---|
| Phone | +46 (0)90-786 57 06 |
| claudia.lampic@umu.se |
Public
BMC, Husargatan 3
Uppsala
751 22
Sweden
| Phone | +46 (0)18-471 66 01 |
|---|---|
| fexcan@uu.se |
Study information
| Study design | Two-armed randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Efficacy |
| Participant information sheet | No available in web format, please use contact details to request a participant information sheet |
| Scientific title | An internet-delivered psychoeducational intervention (Fex-Can 2.0) targeting fertility-related distress and sexual dysfunction in young adults diagnosed with cancer: a randomized controlled trial with an internal pilot phase |
| Study acronym | Fex-Can 2.0 |
| Study objectives | Participation in the intervention is hypothesized to decrease fertility-related distress and sexual dysfunction in comparison to solely receiving standard care. |
| Ethics approval(s) |
Approved 17/05/2023, The Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, 750 02, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: 2023-02745-01 |
| Health condition(s) or problem(s) studied | Young adults diagnosed with cancer who experience fertility-related distress and/or sexual dysfunction |
| Intervention | Participants will be randomly allocated using a computer-generated randomization sequence concealed from the researchers to one of the following groups: 1. Intervention group receiving access to the Fex-Can 2.0 internet-delivered intervention. The intervention is delivered over 12 weeks and consists of modules including educational and behavior change content such as multimedia, interactive online activities and an asynchronous moderated peer discussion forum. Participants will receive a recommended set of modules based on their individual needs and problems as assessed in an individual start-up session with a research team member. 2. Control group receiving standard care and follow-up. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Self-reported fertility-related distress is measured with the Reproductive Concerns After Cancer scale (RCAC), assessed at baseline, directly after the end of the 12 week intervention, and 12 weeks after end of the intervention. 2. Sexual function and satisfaction is measured by the Patient Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS SexFS) Brief Sexual Profile, assessed at baseline, directly after the end of the 12 week intervention, and 12 weeks after end of the intervention. |
| Secondary outcome measures | 1. Degree of bother regarding sexual functioning and use of therapeutic aids for sexual activity is assessed with additional items from the PROMIS SexFS measure. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 2. Body image is assessed with the Body Image Scale (BIS). Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 3. Health-related quality of life is assessed using the EORTC Quality of Life Core Questionnaire (EORTC QLQ-C30). Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 4. Symptoms of anxiety and depression are assessed by the Hospital Anxiety and Depression Scale (HADS). Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 5. Self-efficacy related to fertility is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 6. Self-efficacy related to sex life is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 7. Fertility-related knowledge is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 8. Sex-related knowledge is assessed with a study-specific questionnaire. Assessed at baseline, directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. 9. Satisfaction with basic psychological needs will be assessed as a mediator, using the Need Satisfaction and Frustration Scale (NSFS), adapted to needs regarding fertility and sexuality, respectively. Assessed at baseline, at mid-intervention (week 6), directly after the end of the 12-week intervention, and 12 weeks after the end of the intervention. |
| Overall study start date | 01/01/2023 |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 39 Years |
| Sex | Both |
| Target number of participants | 252 |
| Key inclusion criteria | 1. Diagnosed with cancer within the past 5 years 2. Aged 18-39 years at study entry 3. Experiencing significant fertility-related distress and/or sexual problems 4. Prepared to spend at least 30 minutes per week on the intervention website |
| Key exclusion criteria | 1. Inability to communicate in Swedish 2. Suicidality or a significant psychiatric condition |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 01/12/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centres
BMC, Husargatan 3
Uppsala
751 22
Sweden
Beteendevetarhuset, Mediagränd 14
Umeå
901 87
Sweden
Sponsor information
University/education
Department of Public Health and Caring Sciences
BMC, Husargatan 3
Uppsala
751 22
Sweden
| Phone | +46 (0)18-471 66 75 |
|---|---|
| administrationenifv@uu.se | |
| Website | https://www.uu.se/en/ |
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Cancer Research Foundations of Radiumhemmet
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Findings of this trial will be disseminated in the scientific, clinical, general and patient communities via presentations at patient organizations, at conferences and through publications in peer-reviewed journals. Additionally, the results of the study will be disseminated using social media, including Facebook and LinkedIn. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available due to the sensitive nature of the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 29/04/2025 | 01/05/2025 | Yes | No |
Editorial Notes
11/08/2025: The date of first enrolment was changed from 01/08/2025 to 01/10/2025.
01/05/2025: Publication reference added.
10/12/2024: Study's existence confirmed by the Swedish Ethical Review Authority.
