Condition category
Mental and Behavioural Disorders
Date applied
06/03/2017
Date assigned
08/03/2017
Last edited
08/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Childhood cancer care has improved dramatically over the past 20 years and the overall survival rate for childhood cancer is now approaching 80 %. Advances in treatments have ensured this development and children struck by cancer experience increasing periods of disease-free survival. Although most children diagnosed with cancer survive the disease, challenges remain for these children and their families. A growing body of research has shed light on the long-term physical and psychological consequences of cancer and it has been shown that childhood cancer survivors and their parents are at risk for psychological problems. Cognitive behavior therapy (CBT) is effective for a range of psychological disorders and has been tested for the treatment of depression, anxiety and post-traumatic stress disorder. To date, no study has tested CBT tailored to psychological distress in parents of childhood cancer survivors. The aim of this study is therefore to find out whether individualized face-to-face CBT can reduce distress in parents of children previously treated for cancer.

Who can participate?
Parents of childhood cancer survivors who experience suffering related to their child’s cancer, 3 months to 5 years after the end of the child´s treatment for cancer.

What does the study involve?
Participating parents are offered 10-15 weekly 45-minute sessions of individual CBT. Psychological distress (post-traumatic stress, depression, anxiety) is assessed before treatment, at the end of treatment, and at 3 months follow-up.

What are the possible benefits and risks of participating?
Possible benefits include reductions in distress as similar treatments have been shown to be effective. Regarding possible risks, participants might experience increased distress at the start of the treatment as they may be reminded about distressing events. Participants who do not experience improvement or who deteriorate during the treatment might have less confidence in psychological treatments in the future.

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?
March 2012 to December 2015

Who is funding the study?
1. Swedish Research Council
2. Swedish Cancer Society

Who is the main contact?
Dr Martin Cernvall

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Cernvall

ORCID ID

http://orcid.org/0000-0002-7237-4429

Contact details

Uppsala universitet
Uppsala biomedicinska centrum
Institutionen för kvinnors och barns hälsa
Klinisk psykologi i hälso- och sjukvård
Box 572
Uppsala
75123
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Petra

Study information

Scientific title

Development and preliminary evaluation of Individualized face-to-face cognitive behavior therapy for psychological distress in parents of childhood cancer survivors

Acronym

Study hypothesis

Since there are no evidenced-based interventions for parents of childhood cancer survivors who experience suffering related to their child's illness, the purpose of the current study was to develop and preliminary evaluate if individual CBT can reduce distress among these parents.

Ethics approval

Regional Ethics Committee of Uppsala, 17/12/2012, Dnr: 2012/440

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

Psychological distress (posttraumatic stress, depression, anxiety)

Intervention

Included parents are offered 10-15 weekly 45-minute sessions of individual CBT provided by two resident psychologists under supervision. Psychological distress (post-traumatic stress, depression, anxiety) is assessed before treatment, at the end of treatment, and at 3-months follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. 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
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. Anxiety, assessed with the Beck Anxiety Inventory (BAI) at baseline, post-treatment and at 3 months after end of treatment

Secondary outcome measures

1. Experiential avoidance, assessed with the Acceptance and Action Questionnaire (AAQ-II) at baseline, post-treatment and at 3 months after end of treatment
2. Worry, assessed with the Penn State Worry Questionnaire (PSWQ) at baseline, post-treatment and at 3 months after end of treatment
3. Rumination, assessed with the Rumination Scale of the Response Style Questionnaire (RSQ) at baseline, post-treatment and at 3 months after end of treatment
4. Perceived quality of life, assessed with the Satisfaction with Life Scale (SWLS) at baseline, post-treatment and at 3 months after end of treatment
5. 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

01/03/2012

Overall trial end date

04/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of children who have finished a successful cancer treatment 3 months to 5 years previously
2. Who experience suffering that they relate to the child's disease
3. Swedish speaking
4. Live relatively close to Uppsala, Västerås or Gävle

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Suffer from a psychiatric disorder in immediate need of treatment
2. In psychotherapy
3. If they have suicidal ideations

Recruitment start date

01/02/2013

Recruitment end date

15/02/2014

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

Department of Public Health and Caring Sciences
Box 265
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

government non-federal

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 high impact journal approximately 12 months after the last data-collection.

IPD sharing plan
Ethical restrictions prohibit making the dataset publicly available. The ethical approval obtained ensures use of the dataset to answer the already stipulated research questions and to ensure that the data are processed in accordance with the Swedish Personal Data Act (Swedish: Personuppgiftslagen; 1998:204). Data are available at request from the research group Clinical Psychology in Healthcare at the Department of Public Health Care Sciences, Uppsala University for researchers who meet the criteria for access to confidential data. Requests should be sent to PI Prof. Louise von Essen.

Intention to publish date

01/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes