Condition category
Mental and Behavioural Disorders
Date applied
07/08/2017
Date assigned
22/08/2017
Last edited
07/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.uu.se

Funders

Funder type

Government

Funder name

Vetenskapsrådet

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

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

foundation

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes