Plain English Summary
Background and study aims
Young people who are diagnosed with cancer during adolescence may suffer from psychological distress after the end of cancer treatment. Cognitive behavior therapy (CBT) is a talking therapy that is effective for a range of psychological disorders and has been tested for the treatment of depression, anxiety and post-traumatic stress disorder. There are currently few psychological treatments developed specifically to fit the needs of young survivors of cancer and no study has tested individualized CBT specifically tailored to reduce psychological distress in young survivors of cancer diagnosed during adolescence. The aim of this study is therefore to develop and test a CBT-based treatment targeting cancer-related psychological distress experienced by young people who have completed treatment for cancer diagnosed during adolescence.
Who can participate?
Young people aged between 15-25 who have been diagnosed with cancer during adolescence, have completed successful cancer treatment and experience cancer-related suffering
What does the study involve?
Participants are offered up to 15 weekly 45-minute sessions of individual CBT provided by three resident psychologists. Psychological distress is assessed before treatment, at the end of treatment, and at 3 months after the end of treatment.
What are the possible benefits and risks of participating?
By enrolling in this study participants can receive psychological support. There are no anticipated side effects of the treatment. Working with one's mental health problems can involve some distress. Participants who do not experience improvement or who deteriorate during the treatment might have less confidence in psychological treatments in the future. Participants in need of immediate/more intensive/other psychological treatment than can be offered within this study are guided to appropriate healthcare.
Where is the study run from?
Uppsala University Children's Hospital (Sweden)
When is the study starting and how long is it expected to run for?
May 2014 to October 2016
Who is funding the study?
1. Swedish Research Council
2. Swedish Childhood Cancer Foundation
3. Swedish Cancer Society
Who is the main contact?
Prof. Louise von Essen
louise-von.essen@kbh.uu.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Louise von Essen
ORCID ID
http://orcid.org/0000-0001-5816-7231
Contact details
Uppsala universitet
Uppsala biomedicinska centrum
Institutionen för kvinnors- och barns hälsa
Klinisk psykologi i hälso- och sjukvård
Box 572
Uppsala
75123
Sweden
+46 (0)184 713 484
louise-von.essen@kbh.uu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
U-CARE: MAYA
Study information
Scientific title
Development of psychological treatment for cancer-related suffering experienced by young people diagnosed with cancer during adolescence
Acronym
Study hypothesis
Since there are no evidence-based interventions for young survivors of cancer during adolescence who experience cancer-related suffering, the purpose of the current study was to develop and preliminary evaluate if individual CBT can reduce distress among these survivors.
Ethics approval
Regional Ethical Review Board in Uppsala, Sweden, 22/12/2014, Dnr: 2014/443
Study design
Single-group non-randomised open trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
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 are offered up to 15 weekly 45-minute sessions of individual CBT provided by three resident psychologists under supervision. The CBT interventions are based on a clinical behavior analysis. Psychological distress is assessed before treatment (baseline), at the end of treatment (post-treatment), and 3-months after end of treatment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Anxiety, assessed with the Beck Anxiety Inventory (BAI) at baseline, post-treatment and at 3 months after end of treatment
2. Depression, assessed with the Montgomery Åsberg Depression Rating Scale Self-assessment (MADRS-S) at baseline, post-treatment and at 3 months after end of treatment
3. Post-traumatic stress symptoms, assessed with the The PTSD Checklist - Civilian (PCL-C) at baseline, post-treatment and at 3 months after end of treatment
4. Worry, assessed with the Penn State Worry Questionnaire (PSWQ) at baseline, post-treatment and at 3 months after end of treatment
Secondary outcome measures
1. Body dissatisfaction, assessed with the Body Image Scale (BIS) at baseline, post-treatment and at 3 months after end of treatment
2. Experiential avoidance, assessed with the Acceptance and Action Questionnaire (AAQ-II) at baseline, post-treatment and at 3 months after end of treatment
3. Fatigue, assessed with the Fatigue Assessment Scale (FAS) at baseline, post-treatment and at 3 months after end of treatment
4. Functional impairment, assessed with the Sheehan Disability Scale (SDS) at baseline, post-treatment and at 3 months after end of treatment
5. Health anxiety, assessed with the Short Health Anxiety Inventory (SHAI) at baseline, post-treatment and at 3 months after end of treatment
6. Somatic symptoms, assessed with the Patient Health Questionnaire-15 (PHQ-15) at baseline, post-treatment and at 3 months after end of treatment
7. Rumination, assessed with the Rumination Scale of the Response Style Questionnaire (RSQ): at baseline, post-treatment and at 3 months after end of treatment
8. The presence of psychiatric disorders, assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I), a structured diagnostic psychiatric interview for DSM-IV and ICD-10, at baseline, post-treatment and at 3 months after end of treatment
Overall trial start date
01/05/2014
Overall trial end date
10/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 15-25 years at study start
2. Diagnosed with cancer when aged 13-18 years
3. Treated at a paediatric oncology unit in Sweden
4. Completed successful cancer treatment
5. Experience cancer-related suffering
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Currently receive psychological treatment
2. Display psychiatric symptoms in immediate need of treatment
Recruitment start date
27/02/2015
Recruitment end date
03/11/2015
Locations
Countries of recruitment
Sweden
Trial participating centre
Uppsala University Children's Hospital
Akademiska barnsjukhuset, ing. 95 nbv
Uppsala
75185
Sweden
Sponsor information
Organisation
Uppsala University
Sponsor details
Box 256
Uppsala
75105
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Vetenskapsrådet
Alternative name(s)
Swedish Research Council, VR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Sweden
Funder name
Barncancerfonden
Alternative name(s)
Swedish Childhood Cancer Foundation
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
Trusts, charities, foundations (both publically funded and privately funded)
Location
Sweden
Results and Publications
Publication and dissemination plan
The results from the trial will be published in a doctoral dissertation at Uppsala University and will be submitted for publication in a scientific journal approximately in November 2017.
IPD sharing statement
Ethical restrictions prohibit making the dataset publicly available. Data are available on request from the research group Clinical Psychology in Healthcare at the Department of Women's and Children's Health, Uppsala University for researchers who meet the criteria for access to confidential data. Requests should be sent to PI Prof. Louise von Essen (louise-von.essen@kbh.uu.se).
Intention to publish date
01/11/2017
Participant level data
Available on request
Basic results (scientific)
Publication list