Clinical trial NCT03833817: Patient-caregiver Communication Intervention for Prognostic Understanding
Official title: A Communication-based Intervention for Advanced Cancer Patient-caregiver Dyads to Increase Engagement in Advance Care Planning and Reduce Caregiver Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: advance care planning
prognostic understanding
communication
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility 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

Primary outcomes:
measure: Change in Prognostic Understanding
timeFrame: Baseline, post-intervention (within 30 days)
Secondary outcomes:
measure: 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
timeFrame: Baseline, post-intervention (within 30 days)
measure: 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
timeFrame: Baseline, follow-up (3 months)
measure: 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
timeFrame: Baseline, post-intervention (within 30 days)
measure: 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
timeFrame: Baseline, follow-up (3 months)
measure: 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
timeFrame: Baseline, post-intervention (within 30 days)
measure: 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 3-month Follow-up
timeFrame: Baseline, follow-up (3 months)
measure: Change in the Number of Advance Directives Completed
timeFrame: Baseline, post-intervention (within 30 days)
measure: Change in Psychological Distress, as Measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, post-intervention (within 30 days)
measure: Change in Communication Quality, as Measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF)
timeFrame: Baseline, post-intervention (within 30 days)
measure: Change in Caregiver Burden (Caregivers Only), as Measured by the Zarit Burden Interview
timeFrame: Baseline, post-intervention (within 30 days)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Megan J Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: