Clinical trial NCT02200731: FAMily Oriented Support (FAMOS): Psychosocial Intervention for Childhood Cancer Survivors and Their Families
Official title: FAMOS: The Effect of Psychosocial Intervention for Childhood Cancer Survivors and Their Families: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: Childhood cancer
Psychosocial intervention
Family
Siblings
Childhood cancer survivors
Cogntive Behavioural
Manualized
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Odense University Hospital
name: Aarhus University Hospital Skejby
name: Aarhus University Hospital
First posted: 2014-07-25
Enrollment: 185
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate whether a home-based psychosocial family intervention that takes place shortly after ending the primary medical treatment can help families adjust to their cancer-related psychological issues.

Detailed description: The objective of this randomized controlled trial is to investigate whether home-based psychosocial interventions are able to help families of childhood cancer survivors cope with cancer-related psychological issues.

Method: 300 families will be recruited from the four pediatric oncology departments in Denmark where 150 families' will receive a home-based psychosocial intervention and 150 families will be in the control group. The study will take place shortly after the child completes the primary treatment. The primary outcome is post-traumatic stress symptoms (PTSS) in parents and secondary outcomes include among others quality of life, sick-leave, coping strategies and family functioning. Families in the intervention group will receive a 6 session manualized intervention based on a Cognitive Behavioral framework. Four sessions will focus on the parents and two sessions will focus on the child, who had cancer, and his/her siblings. The main goal of the sessions is to teach families how to adapt healthy psychological adjustments to pediatric oncology and prevent PTSS in family members. As a part of the intervention, families will be presented with video clips of other parents discussing how cancer has affected their family, to show common issues in experiencing having a child undergo cancer treatment. Every family member will be asked to complete a set of questionnaires to measure the outcome of the intervention at baseline before the intervention, 6 months follow-up and 12 months follow-up.

It is expected that families in the intervention group experience a larger improvement in their post-traumatic stress symptoms as well as strengthening the family function, quality of life and reducing sick leave compared to the control group.

Eligibility criteria: Inclusion Criteria:

* Families of children in the age range of 0-17 years diagnosed with any kind of cancer and treated at one of the four pediatric oncology departments in Denmark are invited to participate in the project after ending primary medical treatment.

Exclusion Criteria:

* If the child has a severe co-morbidity
* If the child has a mental disorder at diagnosis
* If the child is declared terminal ill at the end of treatment (less than 6 months of survival).
* If the parents and the children do not speak Danish. The participants have to be able to read and answer the questionnaires at the least, to be included in the project.
* If the parents do not wish to hand in consent form
* If the family participates in another randomized psychosocial intervention project

Primary outcomes:
measure: Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
timeFrame: Baseline and 12 months
measure: Post traumatic stress symptoms (PTSS) in childhood cancer survivors and their siblings measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)
timeFrame: Baseline, 6 months and 12 months
measure: Family psychosocial functioning measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0)
timeFrame: Baseline, 6 months and 12 months
measure: Siblings perception measured by the Siblings Perception Questionnaire (SPQ)
timeFrame: Baseline, 6 months and 12 months
measure: Quality of life measured by Pediatric Quality of Life (PedsQL)
timeFrame: Baseline, 6 months and 12 months
measure: Self reported sick leave in parents
timeFrame: Baseline, 6 months and 12 months
measure: Less stress induced telomere shortening
timeFrame: Baseline and 12 months
measure: Anxiety and depression in parents of childhood cancer survivors measured by the Symptom Checklist (SCL)
timeFrame: Baseline, 6 months and 12 months
measure: Anxiety and depression in siblings over 18 years of childhood cancer survivors measured by the Symptom Checklist (SCL)
timeFrame: Baseline, 6 months and 12 months
measure: Anxiety and depression in childhood cancer survivors and their siblings i the age range 8 to 17 years measured by the Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Cancer Society
Study officials:
affiliation: Danish Cancer Society
name: Christoffer Johansen, Phd, Dr. MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Cancer Society
name: Hanin Salem, Phd student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bidstrup PE, Salem H, Andersen EW, Schmiegelow K, Rosthoj S, Wehner PS, Hasle H, Dalton SO, Johansen C, Kazak AE. Effects on Pediatric Cancer Survivors: The FAMily-Oriented Support (FAMOS) Randomized Controlled Trial. J Pediatr Psychol. 2023 Jan 12;48(1):29-38. doi: 10.1093/jpepsy/jsac062.
citation: Salem H, Kazak AE, Andersen EW, Belmonte F, Johansen C, Schmiegelow K, Winther JF, Wehner PS, Hasle H, Rosthoj S, Bidstrup PE. Home-based cognitive behavioural therapy for families of young children with cancer (FAMOS): A nationwide randomised controlled trial. Pediatr Blood Cancer. 2021 Mar;68(3):e28853. doi: 10.1002/pbc.28853. Epub 2020 Dec 27.