The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence

Официальное название

The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)

Обзор

A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence.

Подробное описание

The current SMART trial aims to address the following hypotheses:

Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance.

Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, face-to-face ConquerFear than to augment eConquerFear with eHealthMaintenance.

Hypothesis 3: eConquerFear + ConquerFear will lead to the greatest reduction in fear of cancer recurrence.

Hypothesis 4: There would be an indirect effect of stepped-care ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition and cognitive attentional syndrome.

Вмешательства

• Поведенческое eConquerFear
  The key goals of this e-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 eHealthMaintenance
  eHealthMaintenance 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.
• Поведенческое ConquerFear
  ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.
• Поведенческое eConquerFear+eHealthMaintenance
  The combination of eConquerFear and eHealthMaintenance interventions, that consists of 10 weekly online modules.

Первичные конечные точки

• Change of fear of cancer recurrence (FCR) [Срок оценки: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention]

Вторичные конечные точки (2)

• Change of metacognitions [Срок оценки: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention]
• Change of cognitive attentional syndrome [Срок оценки: baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention]

Критерии участия

Критерии включения

• Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score of 13 to 21 indicating subclinical FCR will be included.

Критерии исключения

• Patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.

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 · 1 центр

• QMh department of surgery — Гонконг

Идентификаторы

NCT: NCT06181331 · FCR-SMART

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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