e-Motion : Promoting Emotion Regulation in Chronic Cancer

Официальное название

Promoting Emotion Regulation in Patients Living With Chronic Cancer : A Pilot Feasibility, Acceptability and Tolerability Study (e-Motion Project)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Guided Self-Help intervention
  This intervention will consist of 8 self-administered modules that patients will complete every week. The sessions integrate an emotion regulation component with breathing exercises, relaxation exercises, hypnosis, etc. Once a week (maximum 15-minute), a trained psychologist will call the patient to help and/or encourage them. Each module will consist of podcasts, a reading assignment (with psycho-educational information) and writing assignments. The intervention will include home exercises and
• Поведенческое Group and Guided Self-Help intervention
  It will consist of the same content described above, but given in 8 group sessions (2-hour) held by videoconference (Zoom) that will take place every week. Patients will also have access to the podcasts, home exercises and reading assignment, but will benefit from increased motivation and support from both the therapist and their peers in the group. Each group will be composed of 5 patients.

Первичные конечные точки

• Recruitment rate [Срок оценки: Baseline (T0)]
• Retention rate [Срок оценки: Baseline (T0), Weekly 15 (T2)]
• Adherence to intervention [Срок оценки: Weeks 1 to 12 (intervention with weekly call)]
• Adherence to between-session practice [Срок оценки: Weeks 1 to 12 (intervention with weekly call)]
• Data completeness self-report questionnaire [Срок оценки: Baseline (T1) and Weekly 15 (T2)]
• Data completeness EMA [Срок оценки: Baseline (T1), Weeks 1 to 12 (Ecological weekly assessment), Weekly 15 (T2)]
• Satisfaction of the intervention [Срок оценки: Week 15 (T2)]
• Willingness to recommend [Срок оценки: Week 15 (T2)]
• Dropout rate due to intervention-related burden [Срок оценки: Baseline (T1), Weeks 1 to 12 (Intervention), Weekly 15 (T2)]
• Self-reported emotional impact [Срок оценки: Week 15 (T2)]

Вторичные конечные точки (5)

• The Generalized Anxiety Disorders 7 items (GAD-7) [Срок оценки: Baseline (T1), Week 15 (T2)]
• The Patient Health Questionnaire 9 items (PHQ-9) [Срок оценки: Baseline (T1), Week 15 (T2)]
• The Penn State Worry Questionnaire (PSWQ) [Срок оценки: Baseline (T1), Week 15 (T2)]
• Fear of Cancer Recurrence Inventory (FCRI) [Срок оценки: Baseline (T1), Week 15 (T2)]
• Self-efficacy [Срок оценки: Baseline (T1), Week 15 (T2)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Бельгия · 2 центра

• Institut Jules Bordet, Hôpital universitaire de Bruxelles — Brussels
• H.U.B Institut Jules Bordet — Brussels

Идентификаторы

NCT: NCT07236021 · PO20250132

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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