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 measure
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 (if study stopped)
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
Total final enrolment
15
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
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
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
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29666751 (added 14/05/2019