ISRCTN ISRCTN36621459
DOI https://doi.org/10.1186/ISRCTN36621459
Secondary identifying numbers N/A
Submission date
20/01/2016
Registration date
25/01/2016
Last edited
28/02/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Cancer in adolescence and young adulthood is very disruptive to a person’s life and may interfere with important life goals such as finding a partner and building a family. There is limited amount of knowledge, however, about how many young persons with cancer have sexual problems (sexual dysfunction) and how much they worry about their ability to have biological children (fertility-related distress). The study aims to test the effect of a web-based intervention (i.e. program) to alleviate fertility-related distress and sexual dysfunction in adolescents and young adults with cancer.

Who can participate?
Patients diagnosed with lymphoma, testicular cancer, ovarian cancer, breast cancer, cervix cancer and tumors of the central nervous system and aged between 15 and 39 at the time of diagnosis.

What does the study involve?
The project includes two studies. In the first study, adolescents and young adults diagnosed with cancer are asked to complete questionnaires that measure sexual health and worry about their ability to have children. They are asked to complete this questionnaire one year, three years and five years after diagnosis. In addition, young people from the general population that do not have cancer also answer the same questions so that the answers can be compared. All the young people with cancer that report sexual problems and/or worry about their ability to have biological children one year after diagnosis are then invited to take part in the second study. They are randomly allocated to one of two groups. Those assigned to the “web-based intervention” group are given access to a web-based program. The program includes information on the impact of cancer treatments on fertility and sexuality, and present ways to deal with problems in these areas. The materials that make up the program include informative texts, multimedia (pictures, video vignettes and audios) and interactive online activities as well as a discussion forum and the possibility to pose questions to experts and receive personal feedback. The program aims to affect participants’ sense of control over one’s life (autonomy), competence on how to deal with difficulties, and relatedness (“I am not alone with these problems”). Participants assigned to the “control group” receive standard care and follow-up. All young people in both groups are then followed up 12 weeks after being assigned to their group, 3 years later and, finally, 5 years later, to assess fertility-related distress, sexual dysfunction and quality of life.

What are the possible benefits and risks of participating?
Benefits not provided at time of registration. There is a risk that questions regarding sexual function and fertility-related distress can evoke thoughts and worry in participants. For those individuals who are randomized to the control arm (standard care) there is also a risk of being disappointed for not being able to participate in the intervention. Those randomized to receive the intervention may benefit if the intervention shows to be effective in improving sexual function and reducing fertility-related distress.

Where is the study run from?
Department of Neurobiology, Care Sciences and Society at Karolinska Institutet (Sweden)

When is the study starting and how long is it expected to run for?
December 2016 to December 2018

Who is funding the study?
1. The Swedish Childhood Cancer Foundation
2, The Doctoral School in Health Care Science
3, The Cancer Research Foundations of Radiumhemmet
4, The Swedish Cancer Society
5, The Vårdal Foundation
6, The Swedish Research Council for Health, Working Life and Welfare

Who is the main contact?
1. Dr Lena Wettergren
lena.wettergren@ki.se
2. Dr Claudia Lampic
claudia.lampic@ki.se

Contact information

Dr Lena Wettergren
Public

Department of Neurobiology
Care Sciences and Society
Karolinska Institutet, 23300
Huddinge
141 83
Sweden

ORCiD logoORCID ID 0000-0003-1279-2191
Phone +46 (0)8 524 83650
Email lena.wettergren@ki.se
Dr Claudia Lampic
Public

Department of Neurobiology
Care Sciences and Society
Karolinska Institutet, 23300
Huddinge
141 83
Sweden

Phone +46 (0)8 524 88661
Email claudia.lampic@ki.se

Study information

Study designRandomized controlled trial with two arms
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleFex-Can – interventions to alleviate impact of cancer on fertility and sexuality among adolescents and young adults
Study acronymFex-Can (Fertility and sexuality following cancer)
Study objectivesThe study aims to test the effect of a web-based intervention to alleviate fertility-related distress and sexual dysfunction in adolescents and young adults with cancer who report distress and dysfunction.
Ethics approval(s)Regional Ethical Review Board in Stockholm, 11/27/2013, 12/29/2014 and 02/12/2015, refs 2013/1746-31/4, 2014/2244-32, 2015/2042-32/4
Health condition(s) or problem(s) studiedAdolescents and young adults diagnosed with selected cancers (lymphoma, testicular cancer, ovarian cancer, breast cancer, cervix cancer and CNS tumors).
InterventionIndividuals will be identified through national cancer registers, approached by postal mail one year post-diagnosis and asked to complete standardized questionnaires. Those rating high levels of fertility-related distress and sexual dysfunction will invited to participate in an randomized controlled trial.

Participants are then randomly allocated to one of the following groups:
1. The web-based intervention group which will be given access to a web-based intervention with educational and behavior change content, and include multimedia (pictures, video vignettes and audios), interactive online activities (e.g. self-monitoring) and partial feedback support (discussion forum, tailored feedback from experts)
2. Control group, which will receive standard cancer care and follow-up
Intervention typeBehavioural
Primary outcome measure1. Fertility-related distress, measured with the Reproduction Concerns After Cancer (RCAC) scale
2. Sexual function, measured with the PROMIS Sexual Function and Satisfaction Measures (global satisfaction with sex life, interest in sexual activity, lubrication, vaginal discomfort, erectile function, orgasm) and selected items developed for use among cancer populations

The effect of the intervention will be evaluted 12 weeks (T2) and 24 weeks (T3) after randomization (short-term evaluation), and 3 years (T4) and 5 years (T5) after diagnosis (long-term evaluation).
Secondary outcome measuresHealth-related quality of life, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

12 weeks (T2) and 24 weeks (T3) after randomization (short-term evaluation), and 3 years (T4) and 5 Years (T5) after diagnosis (long-term evaluation).
Overall study start date01/12/2016
Completion date31/12/2018

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participantsApproximately 75 persons will be included in each arm (intervention vs. standard care)
Total final enrolment124
Key inclusion criteria1. Diagnosed with lymphoma, testicular cancer, ovarian cancer, breast cancer, cervix cancer and tumors of the central nervous system
2. Twelve months post-diagnosis
3. Aged 15 to 39 at diagnosis
4. Rating fertility-related distress or sexual dysfunction
Key exclusion criteriaPatients who do not understand and speak the Swedish language
Date of first enrolment01/02/2017
Date of final enrolment31/01/2018

Locations

Countries of recruitment

  • Sweden

Study participating centre

Karolinska Institutet
Alfred Nobels Allé 23, 23 300
Huddinge
SE-141 83
Sweden

Sponsor information

Karolinska Institutet
University/education

Solnavägen 1, Solna
Stockholm
171 77
Sweden

Phone +46 (0)8524 80000
Email info@ki.se
Website http://ki.se/en/startpage
ROR logo "ROR" https://ror.org/04hmgwg30

Funders

Funder type

Charity

Barncancerfonden
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Swedish Childhood Cancer Foundation
Location
Sweden
The Doctoral School in Health Care Science

No information available

Radiumhemmets Forskningsfonder
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Cancer Research Foundations of Radiumhemmet
Location
Sweden
Cancerfonden
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Swedish Cancer Society
Location
Sweden
Vårdalstiftelsen
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Vårdal Foundation, Foundation for Health and Allergy Research, Swedish Foundation for Health Care Sciences and Allergy Research
Location
Sweden
Forskningsrådet om Hälsa, Arbetsliv och Välfärd
Government organisation / Local government
Alternative name(s)
Swedish Research Council for Health, Working Life and Welfare, FORTE
Location
Sweden

Results and Publications

Intention to publish date30/06/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planShort-term evaluation is planned to be published during 2018
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications Web-Based Intervention Development 12/04/2016 Yes No
Results article Results 29/03/2022 30/03/2022 Yes No
Protocol article 11/04/2019 17/08/2022 Yes No
Other publications 18/07/2017 28/02/2024 Yes No
Other publications qualitative thematic analysis "What do young adults communicate?" 04/07/2023 28/02/2024 Yes No

Editorial Notes

28/02/2024: Publication references added.
17/08/2022: Publication reference added.
30/03/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
3. Internal review.
25/09/2017: Internal review.
14/04/2016: Publication reference added.