Clinical trial · Interventional
Patient-caregiver Communication Intervention for Prognostic Understanding
A Communication-based Intervention for Advanced Cancer Patient-caregiver Dyads to Increase Engagement in Advance Care Planning and Reduce Caregiver Burden
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Talking about Cancer (TAC) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient intervention arm
- 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).
- interventionNames
- Behavioral: Talking about Cancer (TAC)
- type
- EXPERIMENTAL
- label
- Caregiver (of patient) intervention arm
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available