FAMily Oriented Support (FAMOS): Psychosocial Intervention for Childhood

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Childhood Cancer

Clinical Trial Details

NCT number	NCT02200731
Study type	Interventional
Source	Danish Cancer Society
Contact
Status	Completed
Phase	N/A
Start date	July 2014
Completion date	November 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms