A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

Официальное название

How to Prevent Lost in Transition? - Adaptive Randomised Controlled Trial of a Self-management Based Survivorship Intervention for Chinese Cancer Survivors

Обзор

This study, using a sequential multiple assessment randomized controlled trial (SMART) approach, will evaluate a cancer survivorship care intervention on physical symptom distress, weight management, self-efficacy in managing cancer and health-related quality of life among Chinese patients recently completed curative cancer treatment.

Подробное описание

This study, using this SMART approach, will assess the effect of a cancer survivorship care intervention on physical symptom distress, self-efficacy in managing cancer, weight management and health-related quality of life among Chinese patients recently completing curative cancer treatment. First, the investigators will test the effect of a one-off, multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic) with personalized advice on symptom management, lifestyle modification and anxiety management in reducing the case prevalence of symptom distress, increasing the proportion meeting the weight management criteria, and improving self-efficacy and health-related quality of life among cancer survivors in post-treatment survivorship, in comparison to those receiving skills-based pamphlets for symptom management and lifestyle recommendations. Secondly, this study aims to explore if a step-up targeted personalized intervention is more effective for patients who continue to have symptom distress and/or not to meet the weight management criteria if patients have attended cancer survivorship clinic (i.e. the embedded adaptive intervention) in comparison to those receiving skills-based pamphlets.

Вмешательства

• Поведенческое Cancer survivorship care intervention
  A one-off face-to-face assessment and personal advice by members of a multidisciplinary team
• Поведенческое Step-up targeted personalized intervention
  To provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.
• Поведенческое First stage control intervention
  A set of skill-based pamphlets will be given.
• Поведенческое Second stage control intervention
  Those in the survivorship clinic arm will be asked to follow the advice given by the multidisciplinary team in the initial visit and for those in the control arm will be asked to follow the advices printed in the skill-based self-management pamphlet

Первичные конечные точки

• Proportion of symptom distress caseness (distress prevalence) [Срок оценки: 4-months post-baseline]
• Proportion of patients with suboptimal weight control [Срок оценки: 4-months post-baseline]
• Change in total score of health-related quality of life [Срок оценки: Baseline and 4-months post-baseline]

Вторичные конечные точки (6)

• Change in total scores of self-efficacy [Срок оценки: Baseline, 4-months post-baseline, and 12 months post-baseline]
• Fear of cancer recurrence [Срок оценки: Baseline, 4-months post-baseline, and 12 months post-baseline]
• Illness perception [Срок оценки: Baseline, 4-months post-baseline, and 12 months post-baseline]
• Proportion of symptom distress caseness (distress prevalence) [Срок оценки: 12-months post-baseline]
• Proportion of patients with suboptimal weight control [Срок оценки: 12-months post-baseline]
• Health state [Срок оценки: Baseline, 4-months post-baseline, and 12 months post-baseline]

Критерии участия

Критерии включения

• Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
• have completed primary and adjuvant treatment within the past six months

Критерии исключения

• Patients diagnosed with metastatic cancer

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 7 центров

• Kwong Wah Hospital-Breast Center — Гонконг
• Pamela Youde Nethersole Eastern Hospital-Department of oncology — Гонконг
• Prince of Wales Hospital-Department of Surgery — Гонконг
• Queen Mary Hospital-Department of Obstetrics & Gynaecology — Гонконг
• Queen Mary Hospital-Department of Oncology — Гонконг
• Queen Mary Hospital-Department of Surgery — Гонконг
• Tung Wah Hospital-Department of Surgery — Гонконг

Идентификаторы

NCT: NCT05534386 · UW20-100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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