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This study is closing early to accrual as of 04/10/2026 due to lower than anticipated enrollment, driven by recruitment challenges. The current findings will help develop strategies to improve these processes in future research.
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The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work.
The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work. The study will enroll dyads (pairs) of caregivers and older patients with advanced cancer and dyads of caregivers and patients with advanced cancer. A previous single-arm study was performed testing the feasibility of the adapted DLR intervention in older adults with advanced cancer and their caregivers. The single-arm pilot demonstrated DLR was feasible and acceptable by both patients and caregivers. This innovative pilot study will gather data to test the feasibility of a pilot and examine pre-post intervention changes in caregiver psychological distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyadic Life Review | Experimental | The Dyadic Life Review Arm (DLR) consists of 8 sessions delivered by a trained licensed clinician. Each session facilitates a recall of each phase of life. The patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life. Interventionists are able to use clinical judgment to prompt further or ask follow-up questions or reflections. Additionally, the patient and caregiver will be asked to respond to the other dyad member's memory or reflection. Each session will have flexibility for clinical judgement. |
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| Case-As-Usual | No Intervention | The Care-As-Usual (CAU) arm will follow current practices for responding to patient distress. The CAU for patients involves a supportive follow-up phone call from the social work team to further assess the patient's experience of distress. In some instances, the social worker will use their clinical judgement to further refer the patient to community resources to support distress. The number of phone calls and any subsequent community referrals or appointments related to distress that occur will be tracked. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dyadic Life Review | Behavioral | DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers. |
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| Measure | Description | Time Frame |
|---|---|---|
| DLR Intervention Enrollment Rate | Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate. | 18 weeks |
| DLR Intervention Retention Rate | Evaluate the feasibility of DLR in older patients and caregivers based on retention rate. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Unidimensional Relationship Closeness Scale | Quality of relationship with care-receiver: assesses quality of relationship between participant and family member and has demonstrated valid scores across several relationship types, including spouses and other family members. This is a 12-item scale, rated from 1-7 (1=strongly agree, 7=strongly disagree), with a possible total of 84; a higher score indicates a higher level of closeness. |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
• Unable to identify caregiver to participate in study
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
• Caregivers unable to provide consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 18 weeks |
| Communication Satisfaction Scale | The observation of each partner's level of satisfaction with various aspects of their communication. This is a 12-item scale, rated from 1-5 (1=not at all satisfied, 5=extremely satisfied), with a possible total of 60; a higher score indicates greater satisfaction with communication. | 18 weeks |
| Distress Thermometer | A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress. | 18 weeks |