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

NCT02200731 | Completed

• 1 other identifier: FAMOS
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer

Keywords

Childhood cancer; Psychosocial intervention; Family; Siblings; Childhood cancer survivors; Cogntive Behavioural; Manualized

Outcome Measures

Primary Outcomes (1)

• Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)

  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 Outcomes (10)

• Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)

  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)

  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)

  Baseline, 6 months and 12 months

• Siblings perception measured by the Siblings Perception Questionnaire (SPQ)

  Baseline, 6 months and 12 months

• Quality of life measured by Pediatric Quality of Life (PedsQL)

  Baseline, 6 months and 12 months

Study Arms (2)

FAMOS: psychosocial family intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

FAMOS: psychosocial family intervention BEHAVIORAL

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

FAMOS: psychosocial family intervention

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pernille Bidstrup: lead
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital Skejby: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Danish Cancer Society

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 35849020 DERIVED

• 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.

  PMID: 33369038 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Christoffer Johansen, Phd, Dr. MEd

  Danish Cancer Society

  PRINCIPAL INVESTIGATOR

• Hanin Salem, Phd student

  Danish Cancer Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, group leader

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

DK (1)