Feasibility of CALM in Patients With Ovarian Cancer

Официальное название

A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer

Обзор

The goal of this feasibility trial is to determine the feasibility and acceptability of implementing a brief evidence-based psychotherapeutic intervention, Managing Cancer And Living Meaningfully (CALM), at the time of a new diagnosis and recurrence of ovarian cancer (OC). The main questions are: 1. Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC 2. What are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced OC Participants will be asked to complete questionnaires at baseline and at 3 and 6 months following a diagnosis or recurrence of stage III or IV OC. Participants will also be invited to participate in 3-6 sessions of CALM therapy.

Подробное описание

While CALM has demonstrated effectiveness in reducing depression, death anxiety and increasing preparation for end of life among patients with advanced cancer later in the illness trajectory, its feasibility and effectiveness in addressing traumatic stress symptoms (TSS) soon after a diagnosis of advanced cancer has not previously been established. Findings of this study could inform the potential development of a larger randomized effectiveness trial. This study will involve a multi-method, single-arm, feasibility trial, approaching a total of 100 OC patients (50 newly diagnosed and 50 recently recurred) at Princess Margaret Cancer Centre (PM). Measurements will be administered at baseline, 3 months and 6 months. Participants who declined to participate in the intervention will be invited to share their reasons for opting out, contributing valuable insights to our records. A subset of purposefully sampled participants will also complete qualitative interviews following the completion of outcome measures at 6 months.

Вмешательства

• Другое Managing Cancer And Living Meaningfully (CALM)
  Our team has developed a brief, manualized, individual and couple-based psychotherapeutic intervention for patients living with advanced cancer and their primary caregivers called Managing Cancer and Living Meaningfully (CALM). CALM is a brief supportive-expressive therapy consisting of 3-6 sessions of 30-60 minutes delivered over the course of 3-6 months. This tailored therapy is focused on the most common challenges and concerns facing individuals living with advanced cancer. These four broad

Первичные конечные точки

• Stanford Acute Stress Reaction Questionnaire (SASRQ) [Срок оценки: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)]
• Clinical Evaluation Questionnaire (CEQ)-CALM [Срок оценки: This questionnaire will be administered at 3 months and 6 months only.]

Вторичные конечные точки (4)

• Modified Experiences in Close Relationships (ECR-M-16) [Срок оценки: This questionnaire will be administered at baseline.]
• Condensed Memorial Symptom Assessment Scale (CMSAS) [Срок оценки: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).]
• Patient Health Questionnaire (PHQ-9) [Срок оценки: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).]
• Death and Dying Distress Scale (DADDS) [Срок оценки: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).]

Критерии участия

Критерии включения

• new diagnosis or recurrence of stage III or stage IV OC;
• age ≥18 years
• able to complete outcome measures and engage in CALM in English.

Критерии исключения

• evidence of cognitive impairment indicated in the medical record, communicated by the OC clinic team, or determined by research staff at recruitment;
• receiving psychological or psychiatric counseling from the Department of Supportive Care at PM at the time of recruitment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT06459271 · 23-5885

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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