Parental Support Intervention in an Advanced Oncological Context

Condition(s) studied

Investigational drug(s) / intervention(s)

Psycho-Education: Supporting parents by providing useful informations and recommendations regarding communication with their children.

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).

Study 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.

Eligibility

Primary outcome measure(s)

• Frequency of parental communication with their children about cancer or its consequences — Weeks 2 to 26 (weekly assessment).
  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.
• Quality of parental communication with their children about cancer or its consequences — Weeks 2 to 26 (weekly assessment).
  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.
• Parental communication difficulties — Baseline (T1), week 12 (T2) and week 26 (T3).
  The level of perceived difficulties to communicate is assessed through one item 10-point Likert scale (0 = not at all certain; 10 = absolutely certain).
• Parental self-efficacy regarding the communication with their children about cancer or its consequences — Baseline (T1), week 12 (T2) and week 26 (T3).
  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).
• Participants' communication behaviors — Baseline (T1), week 12 (T2) and week 26 (T3).
  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.
• Theoretical knowledge about the cancer-related concerns of children of different ages — Baseline (T1), week 12 (T2) and week 26 (T3).
  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.
• Under- / Over- communication — Baseline (T1), week 12 (T2) and week 26 (T3).
  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.
• Parental perception of their children's experience of cancer — Baseline (T1), week 12 (T2) and week 26 (T3).
  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.

Trial sites (1)

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