Parental Support Intervention in an Advanced Oncological Context

NCT07341815 | Recruiting

• 1 other identifier: CE3373
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Parental cancer; Parent-child communication; Parenting intervention; Advanced cancer; Adolescent Young Adult (AYA); Uncertainty

Outcome Measures

Primary Outcomes (8)

• Frequency of parental communication with their children about cancer or its consequences

  In the weekly assessment, participants are asked how many moments of communication they had with their child(ren) about cancer, treatments, or their consequences during the past week. This item measures the frequency of communication.

  Weeks 2 to 26 (weekly assessment).

• Quality of parental communication with their children about cancer or its consequences

  A composite communication quality score will be computed for each communication moment reported in the weekly assessments. The score will be based on several dimensions: 1. Initiative, indicating whether the communication was initiated by the parent (yes/no); 2. Duration of the communication moment, reported in minutes; 3. Parental self-efficacy, defined as the perceived ability to inform, listen, answer questions, and reassure, each rated on a 0-10 Likert scale (0 = not at all capable; 10 = completely capable); 4. Comfort during the communication, assessed separately for the parent and the child using a 0-10 Likert scale (0 = not at all comfortable; 10 = extremely comfortable); 5. Disease-related topics discussed (yes/no); 6. Emotional expression, assessed using two yes/no items indicating whether the parent expressed their emotional experience and/or addressed the child's emotional experience related to the disease. Higher scores reflect better communication quality.

  Weeks 2 to 26 (weekly assessment).

• Parental communication difficulties

  The level of perceived difficulties to communicate is assessed through one item 10-point Likert scale (0 = not at all certain; 10 = absolutely certain).

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Parental self-efficacy regarding the communication with their children about cancer or its consequences

  The level of self-efficacy to communicate is assessed through 27 items covering a list of disease-related communication topics (3 subscales of 9 items each : "I know how to communicate", "I am able to communicate" and "I am comfortable to communicate") 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). The total score is obtained by summing the responses to all 27 items (maximum score = 270), and subscale scores are calculated by summing the 9 corresponding items (maximum score = 90).

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Participants' communication behaviors

  The participants' communication behaviors about cancer are assessed through a 13 items 4- point Likert scale (0 = no; 1 = rather no; 2 = rather yes; 3 = yes). Items are phrased as statements such as "I talked about…" and cover a range of disease-related topics. A total score of disease-related communication repertoire is calculated by summing the responses to all items, with higher scores indicating a broader range of topics addressed.

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Theoretical knowledge about the cancer-related concerns of children of different ages

  The level of theoretical knowledge about children's concerns about cancer is assessed through a true-false questionnaire containing 12 items. Correct answers were previously determined by experts in the field. Each correct response is scored as 1 point, and each incorrect response as 0 point. A total knowledge score is obtained by summing the scores across all items, with higher scores reflecting greater theoretical knowledge.

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Under- / Over- communication

  Over- and under-communication are assessed using 10 items, divided into two subscales of 5 items each, rated on a 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). Each subscale score ranges from 0 to 50. For the total score, the under-communication subscale is assigned negative values and the over-communication subscale positive values; the two are then summed, resulting in a possible range from -50 to +50. Higher positive scores indicate a stronger tendency toward over-communication, whereas lower (negative) scores indicate a stronger tendency toward under-communication about cancer.

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Parental perception of their children's experience of cancer

  The parental perception of their children's experience of cancer is assessed through 8 items rated on a 10-point Likert scale (0 = not at all certain; 10 = absolutely certain). A higher item score indicates that the parent feels they have a good understanding of their children's experience regarding the disease-related topic. The total score, which can range from 0 to 80, reflects the parent's overall perception of their children's experience of the disease.

  Baseline (T1), week 12 (T2) and week 26 (T3).

Secondary Outcomes (7)

• Perceived children's communication behaviors

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Parental self-efficacy in general

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Children's academic performance

  Baseline (T1), at the end of the current academic year at the time of week 12 (T4).

• Participant's perception of their AYA's global quality of life (KIDSCREEN)

  Baseline (T1), week 12 (T2) and week 26 (T3).

• Parents' Distress associated with parenting

  Baseline (T1), week 12 (T2) and week 26 (T3).

Other Outcomes (5)

• Communication about cancer or its consequences in the family from the AYA perspective

  Baseline (T1), week 12 (T2) and week 26 (T3).

• AYA's communication wishes

  Baseline (T1), week 12 (T2) and week 26 (T3).

• AYA's future expectations of parental disease and treatments

  Baseline (T1), week 12 (T2) and week 26 (T3).

Study Arms (2)

SOURCE - educational

ACTIVE COMPARATOR

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.

Device: Psycho-Education

SOURCE - experiential

EXPERIMENTAL

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.

Device: Psycho-Education; Behavioral: Psycho-Experiential

Interventions

Psycho-Education DEVICE

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

SOURCE - educational; SOURCE - experiential

Psycho-Experiential 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).

SOURCE - experiential

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe neurological disorder
• Severe psychiatric disorder
• (Pre-)terminal phase of cancer disease

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Centre de Psycho-Oncologie (CPO): collaborator
• Jules Bordet Institute: collaborator
• Erasme University Hospital: collaborator
• Association Jules Bordet: collaborator
• Fonds Thierry Maricq & Véronique Detournay, Fondation Roi Baudouin, Belgium: collaborator

Study Sites (1)

Institut Jules Bordet

Anderlecht, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Communication

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Aurore Liénard, PhD

CONTACT

+32 25417250; aurore.lienard@hubruxelles.be

Isabelle Merckaert, PhD

CONTACT

+32 26504880; isabelle.merckaert@ulb.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr

Model Details: 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.).

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 14, 2026
• Study Start: May 27, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

BE (1)