Parental Support Intervention in the Oncological Context

NCT03905278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-30

No results posted yet for this study

Summary

Background:

Cancer has a significant short and long-term impact on the family. Children of cancer patients may suffer from emotional, behavioral or somatic difficulties. Following the cancer diagnosis, many parents report being concerned about the impact of the illness on their children and how to communicate about the illness. In addition, they feel less able to meet the needs of their children and have difficulties regulating their emotions in response to their children's reactions.

Methods:

A randomized controlled trial was designed to assess the efficacy of a parental guidance intervention centered on communication with children in the context of a parental cancer.

This psychological intervention is designed to help parents and significant caregivers of the children. The participants are randomly assigned to either an intervention group (experimental group) or a waiting list group (control group).

The participants fill out self reported questionnaires that assess the parental self-efficacy in communication, mutual social support, communicational behaviors' with children, parenting concerns,communicational difficulties with children, knowledges about communication with children in oncological context, socio-demographical status, medical situation, psychiatric history, social difficulties and emotional state of the participants and children. The semi-structured interview with participants assesses their day to day communication with the children and the difficulties related to this communication. Those questionnaires are completed at baseline and post treatment (experimental group) and 9 weeks after baseline (control group).

This parental guidance consists of a weekly 4-session intervention. The aim of the sessions are to provide child support in the oncological context, mainly through communication.

Discussion:

This parental guidance would lead to improvements in knowledge, communication, parental self-efficacy and emotional regulation associated with child support.

Conditions

  • Parent-Child Relations
  • Parenting
  • Communication Programs

Interventions

BEHAVIORAL

Parental guidance

A psychological intervention including 4 sessions to assess how participants communicate with their children about the disease and take stock of their questions and difficulties. To identify children's reactions and needs. Practical situation are analyzed and worked through role play centered on communicational difficulties to enhance communicational self-efficacy and mutual support among participants. Emotional regulation strategies are learned through relaxation exercises. A relaxation booklet is given to the participants to practice at home too. Moreover, all participants receive an informational booklet containing age-appropriate recommendations on communication with children about cancer.

Sponsors & Collaborators

  • Centre de Psycho-Oncologie (CPO)

    collaborator OTHER
  • Erasme University Hospital

    collaborator OTHER
  • Jules Bordet Institute

    collaborator OTHER
  • Université Libre de Bruxelles

    collaborator OTHER
  • Aurore Liénard

    lead OTHER

Principal Investigators

  • Razavi · Universite Libre de Bruxelles

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-08
Primary Completion
2021-06-24
Completion
2021-06-24

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03905278 on ClinicalTrials.gov