Patient-caregiver Communication Intervention for Prognostic Understanding

NCT03833817 | Completed Results

• 2 other identifiers: 1803019107R21CA224874
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

advance care planning; prognostic understanding; communication

Outcome Measures

Primary Outcomes (1)

• Change in Prognostic Understanding

  Change in prognostic understanding is assessed at baseline and post-intervention with two items on prognostic understanding: (1) Terminal illness acknowledgement with the item "How would you describe your current health status?" Answer choices include: 1) Relatively healthy, 2) relatively healthy but terminally ill, 3) seriously ill but not terminally ill, and 4) seriously ill and terminally ill, and (5) I don't know\]. Responses 2 and 4 are coded as accurate and responses 1, 3, and 5 are coded as inaccurate. (2) Life-expectancy \[Months, Years, and "I don't know"\]. Months are coded as accurate and years and I don't know are coded as inaccurate. Each variable is coded as 0=inaccurate or 1=accurate, for a total summary score range of 0 to 2. Differences between baseline and post-intervention assessments are calculated (possible range, -2 to +2) to determine changes in prognostic understanding.

  Baseline, post-intervention (within 30 days)

Secondary Outcomes (10)

• Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention

  Baseline, post-intervention (within 30 days)

• Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up

  Baseline, follow-up (3 months)

• Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention

  Baseline, post-intervention (within 30 days)

• Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up

  Baseline, follow-up (3 months)

• Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to Post-Intervention

  Baseline, post-intervention (within 30 days)

Study Arms (2)

Patient intervention arm

EXPERIMENTAL

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).

Behavioral: Talking about Cancer (TAC)

Caregiver (of patient) intervention arm

EXPERIMENTAL

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).

Behavioral: Talking about Cancer (TAC)

Interventions

Talking about Cancer (TAC) 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; Patient intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The statistical analysis plan (and associated statistical power) was based on an expected sample size of 30 evaluable dyads. Due to COVID-19 and restrictions around data collection, only 14 dyads were consented and 8 dyads were evaluable (with n=9 patients, n=8 caregivers). This reduced sample size was not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics for the response proportions can be presented for the study.

Results Point of Contact

• Title: Megan Shen
• Organization: Fred Hutchinson Cancer Center

mshen2@fredhutch.org

206-667-4172

Study Officials

• Megan J Shen, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: September 20, 2020
• Primary Completion: June 17, 2021
• Study Completion: January 18, 2022
• Last Updated: January 31, 2023
• Results First Posted: August 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)