Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

Официальное название

Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial

Обзор

The present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

Подробное описание

A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

The aims are to test:

1. the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and 2. the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Primary hypothesis:

1. Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression. 2. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression. 3. Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Вмешательства

• Поведенческое ConquerFear intervention
  ConquerFear is a manualized intervention, consists of six individual sessions over 10 weeks. The key goals of this intervention are the following: (1) teach strategies for controlling worry and excessive threat monitoring, (2) modify underlying unhelpful beliefs about worry, (3) develop appropriate monitoring and screening behaviours, (4) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (5) clarify values and encourage engagement in values-based goal setting (19).
• Поведенческое CALM intervention
  CALM is a semi-structured, manualized, individual psychotherapy intervention designed for patients with advanced cancer. It includes 3-6 individual therapy sessions, with each approximately lasts 45-60 minutes, delivered over 3-6 months. The sessions cover 4 domains: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) sense of meaning and purpose; and 4) the future and mortality. All modules will be addressed with each patien
• Поведенческое Basic Cancer Care
  Basic Cancer Care intervention for the control arm was developed to help cancer survivors with health maintenance in long-term through providing comprehensive lifestyle guidance. The intervention incorporates relaxation training, dietary and physical fitness consultations with the key goals to (1) teach relaxation techniques, (2) offer personalized diet and physical activity advice, and (3) enhance survivors' perceived control over illness, thereby leading to better adjustment to cancer. Similar

Первичные конечные точки

• Fear of Progression [Срок оценки: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]

Вторичные конечные точки (3)

• Metacognitions [Срок оценки: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
• Depression [Срок оценки: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention]
• Death anxiety [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 patients recently diagnosed with advanced or metastatic (i.e. stage III or IV) cancer
• are the age of 18 years or above

Критерии исключения

• Patients with major communication difficulties
• are being unwilling or unable to commit 6 psychotherapy sessions

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 · 4 центра

• 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: NCT05679518 · UW22-036

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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