Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer

Обзор

This research is being done to test a new communication tool for people with ovarian cancer, caregivers, and clinicians. The name of the intervention in this research study is: -Collaborative Agenda-Setting Intervention (CASI)

Подробное описание

This two-arm, parallel group-randomized research study is to test a new communication tool (CASI) for people with ovarian cancer, caregivers, and clinicians. This is a pilot feasibility study, which means this is the first time researchers are studying CASI. Clinicians will be randomized into one of the two study groups, Arm 1 or Arm 2, and patients and caregivers will be enrolled in the study arm to which their clinician has been randomized.

The research study procedures include screening for eligibility, audio recorded clinic visits, and questionnaires.

Participation in this research study is expected to last for up to 12 weeks for patients and caregivers, and for up to 52 weeks for clinicians.

It is expected that up to 112 people will take part in this research study, including up to 50 patients, 50 caregivers, and 12 clinicians (six dyads).

The National Institute for Nursing Research is supporting this research by providing funding.

Вмешательства

• Поведенческое Collaborative Agenda-Setting Intervention
  A collaborative agenda-setting intervention (CASI) to promote patient-centered communication, set agendas for discussion at in-clinic visits, increase discussion of psychosocial concerns, and reduce clinician burden. The intervention is integrated into the patient portal and electronic health record. Prior to a clinic visit, the intervention elicits patients' and caregivers' preferences and concerns, then communicates this information to clinicians. Patients, caregivers, and clinicians receive c

Первичные конечные точки

• Enrollment Rate [Срок оценки: Pre-consent]

Вторичные конечные точки (5)

• Acceptability of Intervention [Срок оценки: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment]
• Proportion of Participant-Rated Intervention Helpfulness [Срок оценки: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment]
• Proportion of Participant-Rated Intervention Burden [Срок оценки: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment]
• Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1) [Срок оценки: Baseline and 12 weeks after enrollment]
• Change in FACT-G Score from Baseline to 12 Weeks (Arm 2) [Срок оценки: Baseline and 12 weeks after enrollment]

Критерии участия

Participant Inclusion Criteria:

• At least 18 years old
• Able to speak, understand, and respond to questions written in English
• Willing to be audio recorded
• Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease)
• Be under the care of a participating clinician dyad
• Be scheduled for chemotherapy during the recruitment period
• Be signed up or willing to sign up for Patient Gateway

Caregiver Inclusion Criteria:

• At least 18 years old
• Able to speak, understand, and respond to questions written in English
• Willing to be audio recorded
• Be a family member, partner, or friend of a patient participant with whom the patient participant discusses their cancer care

Clinician Inclusion Criteria:

• Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant
• Take care of at least 4 patients per month with advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) in the outpatient setting

Participant Exclusion Criteria:

• Age of <18 years
• Unable to consent

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

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT06543537 · 24-358 · K23NR020219

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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