Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program

Официальное название

Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program for Chinese Cancer Survivors: a Stepped Wedge and Cluster Randomized Trial

Обзор

The purpose of this study is to evaluate the process and outcomes of an implementation program designed to implement fear of cancer screening, referral and management into routine cancer care clinics, using a stepped-wedge cluster randomized controlled trial.

Подробное описание

This study aims to test if a systematic fear of cancer screening program that employs implementation strategies including training, reflecting, evaluating, facilitating and adapting, increases the proportion of eligible patients screened and referred compared to usual control with no implantation strategies used. This study hypothesize that the implementation program will increase (i) the proportion of eligible patients screened and (ii) the proportion of patients with high fear of cancer referred for psychosocial support. For process evaluation, this study aims to use qualitative methods to assess the patients' and service providers' experience of the implementation program, and identify contextual factors (e.g., potential barriers and facilitators) likely to influence its adoption, implementation, and sustainability.

Вмешательства

• Поведенческое FCR screening and referral program
  Five implementation strategies will be conducted individually for each of the study unit at the timepoint when the study unit is being randomly allocated to the implementation condition. For each study unit, all nurses will first receive a half-day training. Each study unit under the implementation condition will receive weekly audit and feedback reports to summarize the proportion of eligible patients, proportion of eligible patients being screened, proportion of patients appropriately referred

Первичные конечные точки

• Change in the number of eligible patient screened [Срок оценки: Pre- and post-implementation phase, up to 24 months]
• Change in the number of eligible patient referred [Срок оценки: Pre- and post-implementation phase, up to 24 months]

Вторичные конечные точки (7)

• Change in referral uptake [Срок оценки: Pre- and post-implementation phase, up to 24 months]
• Process evaluation in providers by conducting qualitative interviews [Срок оценки: Pre- and post-implementation phase, up to 24 months]
• Process evaluation in patients by conducting qualitative interviews [Срок оценки: Pre- and post-implementation phase, up to 24 months]
• Number of staff receiving training [Срок оценки: Pre- and post-implementation phase, up to 24 months]
• Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales [Срок оценки: Pre- and post-implementation phase, up to 24 months]
• Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales [Срок оценки: Pre- and post-implementation phase, up to 24 months]
• Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales [Срок оценки: Pre- and post-implementation phase, up to 24 months]

Критерии участия

Критерии включения

• All patients diagnosed with non-metastatic breast, gynecological, or colorectal cancer, and who have completed primary and adjuvant treatment within the past two years will be eligible for the proposed screening program.

Критерии исключения

• All cancer patients beyond two years post-treatment; and diagnosed with metastatic cancer or non-breast, non-gynecological, and non-colorectal cancer.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Гонконг · 2 центра

• KWH Breast clinic — Гонконг
• QMH department of Surgery — Гонконг

Идентификаторы

NCT: NCT06181344 · UW23-458

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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