FAMily Oriented Support (FAMOS): Psychosocial Intervention for Childhood Cancer Survivors and Their Families

February 4, 2021 updated by: Pernille Bidstrup

FAMOS: The Effect of Psychosocial Intervention for Childhood Cancer Survivors and Their Families: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Danish Cancer Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FAMOS: psychosocial family intervention
The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience.
Behavioral: FAMOS: psychosocial family intervention
The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience
No Intervention: Control
In Denmark, standard care after treatment does not include systematic psychosocial support. Families are able to seek support on their own or contact a support group offered by the Danish Cancer Society. However support specializing the families with childhood cancer survivors and their siblings after ending medial treatment is limited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
Time Frame: Baseline and 6 months
A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 6 months follow up compared to parents in the control group
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
Time Frame: Baseline and 12 months
A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 12 months follow up versus parents in the control group
Baseline and 12 months
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)
Time Frame: Baseline, 6 months and 12 months
A larger reduction in PTSS from baseline to respectively 6 and 12 months follow up in childhood cancer survivors and their siblings the intervention group versus the control group measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)
Baseline, 6 months and 12 months
Family psychosocial functioning measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0)
Time Frame: Baseline, 6 months and 12 months
An larger enhancement in the family's' psychosocial functioning from baseline to 6 months follow up and 12 months follow up measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0) in the intervention group versus the control group.
Baseline, 6 months and 12 months
Siblings perception measured by the Siblings Perception Questionnaire (SPQ)
Time Frame: Baseline, 6 months and 12 months
A change in siblings' perception of how cancer affected their daily life from baseline to 6 months and 12 months follow-up measured by Sibling Perception Questionnaire (SPQ) in the intervention group versus the control group.
Baseline, 6 months and 12 months
Quality of life measured by Pediatric Quality of Life (PedsQL)
Time Frame: Baseline, 6 months and 12 months
An enhancement in quality of life in childhood cancer survivors, their siblings and parents from baseline to 6 month and 12 month follow-up measured by Pediatric Quality of Life (PedsQL) in the intervention group versus the control group
Baseline, 6 months and 12 months
Self reported sick leave in parents
Time Frame: Baseline, 6 months and 12 months
A larger reduction in sick leave for parents from baseline to 6 month and 12 month follow-up measured by self reporting in the intervention group versus the control group.
Baseline, 6 months and 12 months
Less stress induced telomere shortening
Time Frame: Baseline and 12 months
A 10 ml blood sample to measure whether a psychosocial intervention results in a less shortening of the telomere length amongst parents of childhood cancer survivors from baseline to 12 months follow up versus parents in the control group
Baseline and 12 months
Anxiety and depression in parents of childhood cancer survivors measured by the Symptom Checklist (SCL)
Time Frame: Baseline, 6 months and 12 months
A larger reduction in anxiety and depression symptoms in parents of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group
Baseline, 6 months and 12 months
Anxiety and depression in siblings over 18 years of childhood cancer survivors measured by the Symptom Checklist (SCL)
Time Frame: Baseline, 6 months and 12 months
A larger reduction in anxiety and depression symptoms in siblings over 18 years of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group
Baseline, 6 months and 12 months
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)
Time Frame: Baseline, 6 months and 12 months
A larger reduction in anxiety and depression symptoms in childhood cancer survivors and their siblings i the age range 8 to 17 years in the intervention group from baseline to 6 and 12 months follow up compared to the control group
Baseline, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pernille Bidstrup

Collaborators

Odense University Hospital
Aarhus University Hospital
Aarhus University Hospital Skejby
Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Hanin Salem, Phd student, Danish Cancer Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAMOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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