Patient-caregiver Communication Intervention for Prognostic Understanding

NCT ID: NCT03833817

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-20
• Study Completion Date: 2022-01-18

Brief Summary

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).

Conditions

Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient intervention arm

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).

Group Type: EXPERIMENTAL

Talking about Cancer (TAC)

Intervention Type: BEHAVIORAL

The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.

Caregiver (of patient) intervention arm

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).

Group Type: EXPERIMENTAL

Talking about Cancer (TAC)

Intervention Type: BEHAVIORAL

The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.

Interventions

Talking about Cancer (TAC)

The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan J Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21CA224874

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1803019107

Identifier Type: -

Identifier Source: org_study_id