E-intervention on Subclinical Fear of Cancer Recurrence

Официальное название

Conquering Fear Online: a Pilot Randomised Controlled Trial Assessing the Efficacy and Feasibility of an Internet-based Self-management Intervention on Subclinical Fear of Cancer Recurrence

Обзор

The present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based self-management intervention, namely eConquerFear-HK and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local Chinese cancer survivors with subclinical fear of cancer recurrence.

Подробное описание

A pilot randomised controlled feasibility trial will used to test the feasibility, utility, and potential effectiveness of an internet-based self-management intervention for fear of cancer recurrence among local Chinese cancer survivors with subclinical fear of cancer recurrence.

The following hypotheses will be tested:

1. There will be a greater FCR improvement in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group. 2. There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group. 3. There will be greater improvements in secondary outcomes (psychological distress and quality of life) in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group. 4. Cancer survivors receiving eConquerFear-HK intervention will perceive the intervention useful for managing their FCR and be satisfied with the intervention. 5. Cancer survivors receiving eConquerFear-HK intervention will show high completion rates.

Вмешательства

• Поведенческое eConquerFear-HK
  The key goals of the intervention are to: (i) teach strategies for controlling worry and excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry; (iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and encourage engagement in values-based goal setting.
• Поведенческое Basic Cancer Care
  Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 videos about relaxation, generic dietary and exercise knowledge.

Первичные конечные точки

• Rate of subject recruitment [Срок оценки: baseline]
• Rate of subject retention [Срок оценки: baseline,3-months post-intervention and 6-months post-intervention]
• Adherence rate to intervention [Срок оценки: the immediate post-intervention]
• Intervention utility [Срок оценки: the immediate post-intervention]
• Acceptability of the intervention [Срок оценки: the immediate post-intervention]
• Change of fear of cancer recurrence [Срок оценки: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]

Вторичные конечные точки (5)

• Change of quality of life [Срок оценки: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
• Change of general psychological distress [Срок оценки: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
• Attitude towards internet assessed using categorical Likert scales [Срок оценки: the immediate post-intervention]
• Treatment satisfaction [Срок оценки: the immediate post-intervention]
• Change of metacognition [Срок оценки: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]

Критерии участия

Критерии включения

• Cantonese- or Mandarin-speaking Chinese cancer survivors
• recently diagnosed with potentially curable (stage 0 to III) colorectal or breast cancer
• had recently completed surgery as primary treatment
• have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past six months
• scored 13 to 21 on the fear of cancer recurrence-short form will be recruited.

Критерии исключения

• non-Chinese ethnicity
• metastatic cancer
• with current diagnosis of depression or psychosis or are currently receiving psychological treatments
• language or intellectual difficulties that prevent them from understanding the intervention content
• having limited or no Internet access.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Queen Mary Hospital-Department of Surgery — Гонконг

Идентификаторы

NCT: NCT06207006 · UW22-602

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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