Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and Their Support Person

Официальное название

Community-Engaged Pilot Testing of Talking About Cancer (TAC) to Improve Engagement in Advance Care Planning

Обзор

This clinical trial studies whether telephone-based coaching sessions, Talking About Cancer (TAC), work to improve engagement in advance care planning (ACP) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and their support person. Participation in ACP, which includes having end of life (EOL) care conversations and completing advance directives (e.g., living will, health care proxy, do not resuscitate order), improves quality EOL care. Despite this, less than half of patients with advanced cancer have EOL care conversations or complete advance directives. TAC coaching sessions are delivered by a social worker over the phone. They are designed to help patients and their support person communicate about ACP, manage the distress these conversations can cause, and participate in the process of ACP with a clear action plan of having goals-of-care conversations and completing advance directives. This may be an effective way to improve ACP participation in advanced cancer patients and their support person.

Подробное описание

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants attend Talking About Cancer (TAC) telephone-based coaching sessions (2 sessions) designed to support participants in communicating about advance care planning (ACP), managing distress around ACP conversations, engaging in the process of ACP, and completing advance directives over 45-60 minutes each once a week (QW) for 2 weeks.

ARM II: Participants receive an ACP brochure/handout on study.

After completion of study intervention, participants are followed up at 6- and 12-weeks post-randomization.

Вмешательства

• Другое Supportive Care
  Attend TAC telephone-based coaching sessions
• Поведенческое Telephone-Based Intervention
  Attend TAC telephone-based coaching sessions
• Другое Survey Administration
  Ancillary studies
• Другое Educational Intervention
  Receive an ACP brochure/handout

Первичные конечные точки

• Enrollment rate (Feasibility) [Срок оценки: At 6-weeks post-randomization]
• Intervention session completion rate (Feasibility) [Срок оценки: At 6-weeks post-randomization]
• Acceptability of Intervention Measure (AIM) score (Acceptability) [Срок оценки: At 6-weeks post-randomization]
• Completion rate of study assessments (Feasibility of collecting primary and secondary outcomes) [Срок оценки: At baseline, 6-weeks post- randomization, and 12-weeks post-randomization]

Вторичные конечные точки (11)

• Completion of advance directives [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Completion of do not resuscitate (DNR) order [Срок оценки: At baseline, 6-weeks post-randomization, 12-weeks post-randomization]
• Completion of living will [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks randomization]
• Identification of a health care proxy [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Advance care planning (ACP) conversations [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Level of engagement in ACP [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Readiness to engage in ACP [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Self-efficacy for treatment decision-making [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Psychological distress [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Prognostic understanding [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]
• Support person [caregiver] burden [Срок оценки: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization]

Критерии участия

Критерии включения

• PATIENT: Current diagnosis of stage III or IV cancer
• PATIENT: Able to provide informed consent
• PATIENT: Fluent in English or Spanish
• PATIENT: Have access to a telephone, computer, or mobile device
• CAREGIVER (SUPPORT PERSON): Person patient indicates provides support
• CAREGIVER (SUPPORT PERSON): English or Spanish speaking
• CAREGIVER (SUPPORT PERSON): 18 years of age or older
• CAREGIVER (SUPPORT PERSON): Able to provide informed consent

Критерии исключения

• PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer)
• PATIENT: Receiving hospice at the time of enrollment
• PATIENT: Younger than age 18

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Providence Regional Cancer Partnership — Everett
• Skagit Regional Health Cancer Care Center — Mount Vernon
• Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT07141407 · RG1125666 · NCI-2025-05520 · FHIRB0020936

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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