Patient-caregiver Communication Intervention for Prognostic Understanding

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Advanced Cancer

Treatments: Behavioral: Talking about Cancer (TAC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03833817

1803019107

R21CA224874 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to: (1) develop a communication-based intervention to improve advanced cancer patients' and caregivers' prognostic understanding using communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention among advanced cancer patients and their caregivers; and (3) test the preliminary efficacy of the intervention on patients' and caregivers' prognostic understanding (primary outcome); completion of DNR order, living will, and health care proxy; psychological distress; communication quality; caregiver burden; and healthcare utilization (secondary outcomes).

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

• Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy.
• Ability to provide informed consent
• Identification of an informal caregiver
• Oncologist reported discussion of prognosis with the patient and/or caregiver.

Patient Exclusion Criteria:

• Not fluent in English
• Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)
• Too ill or weak to complete the interviews (as judged by the interviewer)
• Currently receiving palliative care/hospice at the time of enrollment
• Children and young adults under age 18
• Deemed inappropriate for the study by their treating oncologist.
• In addition, patient-caregiver dyads in which both members have an accurate understanding of prognosis (terminal status and life-expectancy) will be excluded due to the lack of need for an intervention.

Caregiver inclusion criteria:

• The person (family member or friend) whom the patient indicates provides their informal (unpaid) care
• English speaking
• Able to provide informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Patient intervention arm

Experimental group

Description:

This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6).

Treatment:

Behavioral: Talking about Cancer (TAC)

Caregiver (of patient) intervention arm

Experimental group

Description:

This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6).

Treatment:

Behavioral: Talking about Cancer (TAC)