Condition category
Cancer
Date applied
20/01/2016
Date assigned
25/01/2016
Last edited
14/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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 measures

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

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

http://ki.se/en/startpage

Funders

Funder type

Charity

Funder name

Barncancerfonden

Alternative name(s)

Swedish Childhood Cancer Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

foundation

Location

Sweden

Funder name

Cancerfonden

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

foundation

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

government non-federal

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

Results - basic reporting

Publication summary

2016 intervention development: http://www.ncbi.nlm.nih.gov/pubmed/27073057

Publication citations

Additional files

Editorial Notes

14/04/2016: Publication reference added.