Efficacy of a Parental Support Intervention to Improve Communication of Advanced Cancer Patients With Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Frequency of parental communication with their children about cancer or its consequences
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe neurological disorder
- •Severe psychiatric disorder
- •(Pre-)terminal phase of cancer disease
结局指标
主要结局
Frequency of parental communication with their children about cancer or its consequences
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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).)
- Expectations and Benefits of the intervention(Baseline (T1), week 12 (T2).)
- Perceived usefulness of the interventions(Week 12 (T2).)
研究者
Aurore Liénard
Pr
Université Libre de Bruxelles