Plain English Summary
Background and study aims
Adolescents that have been diagnosed with cancer often suffer from psychological distress, but not all have access to psychological support. There are currently few psychological treatments developed specifically to fit the needs of young survivors of cancer. An internet-based self-help programme for treating symptoms of anxiety and depression in young people diagnosed with cancer has been developed. This study is looking at whether the programme and the study methods that will be used evaluating the programme seem doable and acceptable to those receiving it.
Who can participate?
Young people aged between 15-25 who have been diagnosed with cancer during adolescence, have completed successful cancer treatment and have been identified as needing psychological support.
What does the study involve?
All participants are given access to a 12 week internet-based self-help programme. This programme includes internet-based cognitive behavioral therapy, psychoeducation (education to help people deal with mental health issues) and interactive support. Each participant works independently and is given support by a therapy via internet based messages or by telephone on a weekly basis, or more if requested.
What are the possible benefits and risks of participating?
By enrolling in this study participants can receive psychological support. There are no anticipated adverse effects of the self-help programme. Potential negative effects will however be explored within the study by via interviews with participants following use of the self-help programme. Working with one's mental health problems can involve some distress. However, the programme teach skills to cope with such distress and includes weekly and at-need contact with a therapist who receives supervision from a clinical psychologist. Participants in need of immediate/more intensive psychological treatment than can be offered within this study will be guided to appropriate healthcare.
Where is the study run from?
Uppsala University, in Uppsala (Sweden)
When is study starting and how long is it expected to run for
September 2016 to May 2017
Who is funding the study?
The Swedish Childhood Cancer Foundation
Who is the main contact?
1. Mrs Malin Ander (public)
malin.ander@pubcare.uu.se
2. Professor Louise von Essen (scientific)
louise-von.essen@pubcare.uu.se
Trial website
Contact information
Type
Public
Primary contact
Mrs Malin Ander
ORCID ID
Contact details
Department of Public Health and Caring Sciences
Uppsala University
Box 564
Uppsala
75122
Sweden
+46184713514
malin.ander@pubcare.uu.se
Type
Scientific
Additional contact
Prof Louise von Essen
ORCID ID
http://orcid.org/0000-0001-5816-7231
Contact details
Department of Public Health and Caring Sciences
Uppsala University
Box 564
Uppsala
75122
Sweden
+46184713514
louise-von.essen@pubcare.uu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
U-CARE: YoungCan, BCF PR2013-0039
Study information
Scientific title
Internet-based self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a feasibility trial
Acronym
U-CARE: YoungCan
Study hypothesis
The primary aim of the planned study is to investigate the feasibility of an internet-based self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young people diagnosed with cancer during adolescence, and of the planned study procedures for a future controlled trial to evaluate the programme’s clinical efficacy and cost-effectiveness.
Ethics approval
Regional Ethical Review Board in Uppsala, Sweden, 13/07/2016, ref: 2016/210
Study design
Interventional non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Internet
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cancer-related psychological distress
Intervention
All participants will receive an internet-based self-help programme consisting of internet-based cognitive behavioral therapy (ICBT), psychoeducation and interactive peer support. Participants will work independently with the programme over 12 weeks and receive weekly and at-need support from a therapist via messages within the internet platform via which the programme is delivered or by telephone.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Feasibility of recruitment and eligibility criteria will be evaluated by examining:
1.1. Number of people identified via the Swedish Childhood Cancer Registry, invited via telephone, invited via letter, assessed for eligibility
1.2. Percentages of people interested in participation, assessed for eligibility, meeting the inclusion criteria, and included, of the total number identified
1.3. Ambiguities regarding eligibility criteria
1.4. Reasons for ineligibility and for non-participation
2. Feasibility of data collection will be evaluated by examining:
2.1. Percentage of participants completing the baseline assessment and the assessments three months and six months post baseline
2.2. Numbers of missing items in outcomes
2.3. Types and number of potential uncertainties in diagnostic interviews
3. Attrition, evaluated by calculating dropout rates.
4. Resources needed to complete the study and the programme will be evaluated by examining:
4.1. Length of time for participants to work through the programme and complete questionnaires and interviews
4.2. Length of time for therapists and study personnel to deliver the programme and administer the study
5. Participants’ adherence to programme, evaluated by examining number of activities in the programme
6. Therapists’ adherence to programme, examined by analysing the content of online written therapist-participant communication.
7. Participants’ acceptability of programme and data collection and exploration of mechanisms of impact, via semi-structured interviews
Self-report data will be collected either by telephone or online at one or more of the following time points: the eligibility interview, baseline assessment, assessment three months post baseline (post-assessment) and assessment six months post baseline (follow-up assessment).
Secondary outcome measures
The feasibility of using the following psychological and health economics measurements will be examined to assess whether or not to include them in a controlled study:
1. The PHQ-9 to measure symptoms of depression
2. The GAD-7 to measure anxiety symptoms
3. Body Image Scale Body to measure body image
4. PCL-C to measure posttraumatic stress symptoms
5. SIAS to measure Reactions to social interaction situations
6. The EuroQol EQ-5D to calculate quality-adjusted life years
7. TiC-P to measure aspects regarding use of healthcare services, employment, absence and sick leave
Data will be collected at baseline, and three and six months post baseline
Overall trial start date
01/09/2016
Overall trial end date
01/05/2017
Reason abandoned
Eligibility
Participant inclusion criteria
Eligible participants will:
1. be aged 15-25 years at study start
2. have been diagnosed with cancer when aged 13-18 years
3. have been treated at a paediatric oncology unit in Sweden
4. have completed successful cancer treatment
5. be able to read and write text in Swedish
6. have access to e-mail, the internet, and a mobile telephone
7. report a need for psychological support
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
30
Participant exclusion criteria
Potential participants will be excluded if they:
1. currently receive psychotherapy
2. display symptoms of severe depression, active suicidality, psychosis, bipolar disorder and/or alcohol and/or substance abuse in immediate need of treatment
Recruitment start date
03/10/2016
Recruitment end date
30/11/2016
Locations
Countries of recruitment
Sweden
Trial participating centre
Uppsala University
Box 564
Uppsala
75122
Sweden
Sponsor information
Organisation
Uppsala University
Sponsor details
Box 256
Uppsala
75105
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Swedish Childhood Cancer Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
01/12/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28132011