Condition category
Mental and Behavioural Disorders
Date applied
15/08/2016
Date assigned
15/08/2016
Last edited
15/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

www.u-care.se

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

Other

Age group

Other

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

www.uu.se

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

Publication citations

Additional files

Editorial Notes