Internet-based self-help for adolescents and young adults diagnosed with cancer during adolescence

ISRCTN	ISRCTN97835363
DOI	https://doi.org/10.1186/ISRCTN97835363
Protocol serial number	U-CARE: YoungCan, BCF PR2013-0039
Sponsor	Uppsala University
Funder	The Swedish Childhood Cancer Foundation

Submission date: 15/08/2016
Registration date: 15/08/2016
Last edited: 01/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Malin Ander
Public

Department of Public Health and Caring Sciences
Uppsala University
Box 564
Uppsala
75122
Sweden

Phone	+46184713514
Email	malin.ander@pubcare.uu.se

Prof Louise von Essen
Scientific

Department of Public Health and Caring Sciences
Uppsala University
Box 564
Uppsala
75122
Sweden

ORCID ID	0000-0001-5816-7231
Phone	+46184713514
Email	louise-von.essen@pubcare.uu.se

Study information

Primary study design	Interventional
Study design	Interventional non-randomised study
Secondary study design	Non randomised study
Study type	Participant information sheet
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
Study acronym	U-CARE: YoungCan
Study objectives	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(s)	Regional Ethical Review Board in Uppsala, Sweden, 13/07/2016, ref: 2016/210
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	01/05/2017

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	03/10/2016
Date of final enrolment	30/11/2016

Locations

Countries of recruitment

Sweden

Study participating centre

Uppsala University

Box 564
Uppsala
75122
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	27/01/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/02/2017: Publication reference added.