Parental Support Intervention in an Advanced Oncological Context

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2026-12-31

Brief Summary

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This prospective, two-arm randomized trial compares a psycho-educational program to a psycho-educational and experiential program for parents with advanced cancer. These two interventions aim to support parent-child communication about cancer, but we hypothesize that the combined intervention will be more effective for all studied communication variables.

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Detailed Description

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Background:

A recent review shows that 14-22% of patients with cancer are parents of underaged children or young adults. Following the cancer diagnosis, many parents report being concerned about the impact of the disease on their children and about how to communicate about the disease with them, especially about the uncertainty that is inherent in disease. In addition, they may report a decrease in their parental self-efficacy and in their parental skills to support their children. There are few randomized controlled trials designed to test the efficacy of parenting support interventions in oncology. Moreover, the existing studies use such varied designs and evaluation tools that there is no evidence-based practice in this area to date.

Methods:

The study is a prospective, two-armed randomized trial with two groups receiving either a psycho-educational program or a psycho-educational and experiential program.

This study is offered to patients with advanced cancer who have at least one child aged between 10 and 25 years. All participants must be interested in discussing how to communicate with their children about the disease.

All participants complete a baseline assessment (T1). Then, they are assigned randomly to one of the two intervention groups during a one-hour welcoming session. The second assessment interview (T2) is scheduled two weeks after the end of both interventions. The third assessment interview (T3) takes place 3 months after T2. Finally, a fourth short assessment (T4) is scheduled at the end of the current school year at T2. Moreover, participants are asked to complete a weekly assessment from T1 to T3 (during 6 months).

The "Supporting Open Uncertainty Responses and Communication Engagement : a psycho-educational program" (SOURCE - educational) and the "Supporting Open Uncertainty Responses and Communication Engagement : a psycho-educational and experiential program" (SOURCE - experiential) are based on an informational booklet designed to improve the knowledge of how to communicate with children, adolescents and young adults (AYAs), with a particular focus on communicating about the uncertainty inherent in disease. Both interventions are conducted in 5 to 6 manualized sessions by the same experienced psycho-oncologist.

In the "SOURCE - experiential", sessions last about 1,5 hour and are held in person or by teleconsultation. This intervention is based on support of parental self-efficacy and exercises about parental competence to communicate with their AYAs (role play and support of transfer in daily life).

In the "SOURCE - educational", sessions last about 15 minutes and are held by teleconsultation. It is a psycho-educational intervention aimed at supporting parents by providing information and recommendations regarding communication with AYAs and the potential impact of the disease on them.

Discussion:

It is hypothesized that the parental support provided in the psycho-educational and experiential program will be more effective than sessions offered in the context of the psycho-educational program for all the studied variables, even on communicating about uncertainty, a subject we know to be more sensitive.

EXPLORATORY PART OF THE STUDY Participants are also informed that, if they agree, their children aged between 10 and 25 will be invited to participate to an exploratory part of the study. To be eligible to participate in this exploratory part, AYAs must have a strong command of French, and be aware that their parent has a disease (whether or not called "cancer") and that their parent receive or has received a treatment for that disease. AYAs are excluded if they are living completely independently, if they have severe neurological or psychiatric disorders, or if they are in special-needs education. In order to participate, AYAs must sign a consent document. If they are minors, an additional consent document must be signed by their ill parent, and the co-parent must give an oral consent.A non-participation of the AYA to the study does not affect the inclusion of their parent in the study.

Exploratory outcomes are: (1) communication about cancer or its consequences in the family from the AYA's perspective, (2) AYA's communication wishes, (3) future expectations of parental disease and treatments and (4) global quality of life. Questionnaires are completed three times, at most 48 hours apart from the T1, T2, and T3 of their parent.

Conditions

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Metastatic Cancer Cancer Recurrence Hematological Cancer Parent-Child Relations Parenting Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a two-armed randomized trial with two groups receiving different interventions.

In the "SOURCE - educational", patients benefit from a psycho-educational intervention based on an informational booklet. In the "SOURCE - experiential", the patients benefit from an intervention composed of a psycho-educational part (based on the same informational booklet) and a psycho-experiential intervention (role playing, relaxation exercises, etc.).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Participants are informed of the two existing intervention groups as soon as they are recruited. The participant and the assessor are blind during the first research interview (T1), since randomization is only given after the welcoming session.

Study Groups

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SOURCE - educational

Participants receive an informational brochure created for the study and take part in five or six intervention sessions lasting around 15 minutes each. These sessions focus on the informational content of the brochure, which is summarized in a PowerPoint presentation presented by the psycho-oncologist.

Group Type ACTIVE_COMPARATOR

Psycho-Education

Intervention Type DEVICE

Supporting parents by providing useful informations and recommendations regarding communication with their children.

SOURCE - experiential

Participants receive the same informational brochure and benefit from the same summary presentation in PowerPoint format as in the other arm. In addition, there is an experiential component, meaning that participants raise their specific questions/concerns related to the topics and work on them in a practical way with the psycho- oncologist.

Group Type EXPERIMENTAL

Psycho-Education

Intervention Type DEVICE

Supporting parents by providing useful informations and recommendations regarding communication with their children.

Psycho-Experiential

Intervention Type BEHAVIORAL

(1) Continuous support of parental self-efficacy about parental competence to communicate ; (2) Exercises about improving parental competence to communicate with their children (role-plays, transfer in the daily life).

Interventions

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Psycho-Education

Supporting parents by providing useful informations and recommendations regarding communication with their children.

Intervention Type DEVICE

Psycho-Experiential

(1) Continuous support of parental self-efficacy about parental competence to communicate ; (2) Exercises about improving parental competence to communicate with their children (role-plays, transfer in the daily life).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Metastatic cancer, recurrence of cancer or certain types of hematological cancer (chronic disease, acute leukemia, multiple myeloma or lymphoma recurrence)
* Have at least one child aged between 10 and 25 years
* Wish to benefit from a psychological intervention about communication with their children about cancer or its consequences
* Able to read and speak French
* Accept to give their written informed consent