Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Lena Wettergren
ORCID ID
http://orcid.org/0000-0003-1279-2191
Contact details
Department of Neurobiology
Care Sciences and Society
Karolinska Institutet
23300
Huddinge
141 83
Sweden
+46 (0)8 524 83650
lena.wettergren@ki.se
Type
Public
Additional contact
Dr Claudia Lampic
ORCID ID
Contact details
Department of Neurobiology
Care Sciences and Society
Karolinska Institutet
23300
Huddinge
141 83
Sweden
+46 (0)8 524 88661
claudia.lampic@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Fex-Can – interventions to alleviate impact of cancer on fertility and sexuality among adolescents and young adults
Acronym
Fex-Can (Fertility and sexuality following cancer)
Study hypothesis
The 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
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
Study design
Randomized controlled trial with two arms
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Adolescents and young adults diagnosed with selected cancers (lymphoma, testicular cancer, ovarian cancer, breast cancer, cervix cancer and CNS tumors).
Intervention
Individuals 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 type
Behavioural
Phase
Drug names
Primary outcome measure
1. 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 measures
Health-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 trial start date
01/12/2016
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
Approximately 75 persons will be included in each arm (intervention vs. standard care)
Participant exclusion criteria
Patients who do not understand and speak the Swedish language
Recruitment start date
01/02/2017
Recruitment end date
31/01/2018
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Alfred Nobels Allé 23, 23 300
Huddinge
SE-141 83
Sweden
Sponsor information
Organisation
Karolinska Institutet
Sponsor details
Solnavägen 1
Solna
Stockholm
171 77
Sweden
+46 (0)8524 80000
info@ki.se
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Barncancerfonden
Alternative name(s)
Swedish Childhood Cancer Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Sweden
Funder name
The Doctoral School in Health Care Science
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Radiumhemmets Forskningsfonder
Alternative name(s)
Cancer Research Foundations of Radiumhemmet
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Sweden
Funder name
Cancerfonden
Alternative name(s)
Swedish Cancer Society
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Sweden
Funder name
Vårdalstiftelsen
Alternative name(s)
Vårdal Foundation, Foundation for Health and Allergy Research, Swedish Foundation for Health Care Sciences and Allergy Research
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Sweden
Funder name
Forskningsrådet om Hälsa, Arbetsliv och Välfärd
Alternative name(s)
Swedish Research Council for Health, Working Life and Welfare, FORTE
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Results and Publications
Publication and dissemination plan
Short-term evaluation is planned to be published during 2018
Intention to publish date
30/06/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27073057