N/A
N=28
Patient-caregiver Communication Intervention for Prognostic Understanding
Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03833817 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Change in Prognostic Understanding — 0.00; 0.25 Change in scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Talking about Cancer (TAC) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Prognostic Understanding |
0.00; 0.25 | — |
| SECONDARY 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 |
0.44 | — |
| SECONDARY 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 |
1.14 | — |
| SECONDARY 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 |
0.78 | — |
| SECONDARY 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 |
0.57 | — |
| SECONDARY 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 |
-0.50 | — |
| SECONDARY 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 |
.14 | — |
| SECONDARY Change in the Number of Advance Directives Completed |
0.56 | — |
| SECONDARY Change in Psychological Distress, as Measured by the Hospital Anxiety and Depression Scale (HADS) |
0.33; -2.12 | — |
| SECONDARY Change in Communication Quality, as Measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) |
-1.33; 0.50 | — |
| SECONDARY Change in Caregiver Burden (Caregivers Only), as Measured by the Zarit Burden Interview |
-4.13 | — |
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
Data sourced from ClinicalTrials.gov (NCT03833817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.