Promoting Emotion Regulation in Patients Living With Chronic Cancer : A Pilot Feasibility, Acceptability and Tolerability Study (e-Motion Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Data completeness EMA
研究概览
简要总结
The present study aimed to pilot evaluate two interventions: a Guided Self-Help Intervention alone, and a combined Group and Guided Self-Help Intervention, designed to support individuals living with chronic cancer and recently diagnosed. The primary aim of this pilot study is to assess the feasibility, acceptability and tolerability of the interventions. The secondary aim of the pilot study is to assess the interventions preliminary efficacy and differences on psychological symptoms.
详细描述
The investigators aim to conduct a pilot study to assess feasibility, acceptability and tolerability of two interventions on 30 chronic cancer patients: a Guided Self-Help Intervention and a combined Group and Guided Self-Help Intervention. Both interventions will rely on emotion regulation component, with CBT, hypnosis, and positive psychology techniques.
The first 15 patients that will be recruited will be allocated to the Guided Self-Help Intervention (Arm 1). The recruitment of the 15 other patients will start after the last assessment of the last patient included in the first arm. These 15 other patients will be allocated by group of 5 to the combined Group and Guided Self-Help Intervention (Arm 2). Each participants will be assessed before intervention (T1), during intervention (Ecological weekly assessment, week 1 to week 12) and after the intervention (T2, 15 weeks after T1). T1 and T2 assessments will include self-reported questionnaires about psychological symptoms and a 7-day ecological momentary assessment (EMA) on emotions. In T2, a semi-structured interview will be performed for each participant to collect qualitative information on the tolerability and acceptability of the interventions. Participants will also complete a satisfaction questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Having received a diagnosis of chronic cancer (metastatic breast cancer, metastatic melanoma, metastatic colorectal, metastatic ovarian, metastatic uterine, metastatic endometrial, metastatic prostate, metastatic bladder, metastatic kidney or metastatic testicular cancer, symptomatic multiple myeloma, metastatic non-small cell lung, metastatic mesothelioma or metastatic thymoma) in the past 12 months,
- •Having completed at least one active treatment session (e.g., chemotherapy, surgery, radiotherapy, immunotherapy, target therapy).
排除标准
- •Having less than one year of life expectancy
- •Having more than one treatment line (for triple negative breast cancer, melanoma, gynecological cancer, colorectal cancer, bladder cancer, kidney cancer, non-small cell lung, mesothelioma and thymoma) or two treatment lines (for other breast cancers and testicular cancer) or three treatment lines (for prostate cancer and multiple myeloma),
- •Having a diagnosis of oligometastatic cancer,
- •Age < 18 years,
- •Non-fluency in French,
- •Inability to follow the online intervention,
- •Severe cognitive impairment, and severe and/or acute psychiatric disorder.
结局指标
主要结局
Data completeness EMA
时间窗: Baseline (T1), Weeks 1 to 12 (Ecological weekly assessment), Weekly 15 (T2)
At least 70% of data are collected for the ecological momentary assessments.
Willingness to recommend
时间窗: Week 15 (T2)
At least 80% of patients would recommend the intervention to other patients. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants would recommend this intervention to other patients in their situation. Mean score is ≥ 4 in the satisfaction questionnaire. The questionnaire was developed for this study.
Dropout rate due to intervention-related burden
时间窗: Baseline (T1), Weeks 1 to 12 (Intervention), Weekly 15 (T2)
No more than 10% of patients discontinue participation due to emotional distress or perceived burden linked to the intervention, as assessed by one question of the drop-out questionnaire which is: 'The reasons for this decision are related to: A. The intervention B. The questionnaires C. Both.' The percentage is calculated based on the number of patients who answered A or C.
Retention rate
时间窗: Baseline (T0), Weekly 15 (T2)
At least 80% of patients complete the study to the end. The study completion rate is calculated based on the difference between the number of patients enrolled in T0 and those who completed the study in T2.
Recruitment rate
时间窗: Baseline (T0)
At least 25% of eligible patients agree to participate.
Adherence to between-session practice
时间窗: Weeks 1 to 12 (intervention with weekly call)
At least 70% of patients complete all assigned between-session exercises. The weekly call includes a question asking participants if they have done their exercises throughout the week. Answer with yes or no. The exercise completion rate between sessions is defined as the proportion of patients who reported having completed all weekly exercises among those who responded to the follow-up question.
Adherence to intervention
时间窗: Weeks 1 to 12 (intervention with weekly call)
At least 70% of patients complete all sessions regardless of the intervention arm. The weekly call includes a question asking participants whether they attended the week's session. Answer with Yes or No. If yes: go through all of the following questions. If no: investigate further to see if anything has been done."
Data completeness self-report questionnaire
时间窗: Baseline (T1) and Weekly 15 (T2)
At least 90% of patients complete all data of questionnaires at both time points (T1 and T2).
Satisfaction of the intervention
时间窗: Week 15 (T2)
At least 80% of patients rate the intervention as satisfactory. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates whether, overall, participants were satisfied with the intervention. Mean score is ≥ 4 in the satisfaction questionnaire. Satisfaction will also be assessed through a qualitative analysis (thematic analysis) of the transcript of the exit interview. The questionnaires were developed for this study.
Self-reported emotional impact
时间窗: Week 15 (T2)
At least 80% of patients indicate that the intervention was emotionally manageable and not overly distressing. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants found this intervention emotionally comfortable or bearable. Mean score is ≥ 4 in the satisfaction questionnaire. Self-reported emotion impact will also be based on responses from the exit interviews (which is a semi-structured interview), assessed through a qualitative analysis (thematic analysis). The questionnaires were developed for this study.
次要结局
- The Generalized Anxiety Disorders 7 items (GAD-7)(Baseline (T1), Week 15 (T2))
- The Patient Health Questionnaire 9 items (PHQ-9)(Baseline (T1), Week 15 (T2))
- The Penn State Worry Questionnaire (PSWQ)(Baseline (T1), Week 15 (T2))
- Fear of Cancer Recurrence Inventory (FCRI)(Baseline (T1), Week 15 (T2))
- Self-efficacy(Baseline (T1), Week 15 (T2))
研究者
Prof. Isabelle Merckaert
Professor
Université Libre de Bruxelles