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TerminatedNCT06505122DLR RCTUpdated Jun 11, 2026

Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers

An interventional study of Dyadic Life Review in Cancer, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by University of Rochester · Not applicable, Interventional, and Supportive care

Why this study was terminated
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.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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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Conditions studied

  • Cancer

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Keywords

  • Older Adults
  • Geriatric Oncology
  • Caregivers
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patient Inclusion Criteria:

  • Age ≥ 65
  • Patient has a Stage III or IV advanced cancer diagnosis of any type
  • Score of 4 or more on National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT)*
  • Able to read and understand English

Patient Exclusion Criteria:

  • Unable to identify caregiver to participate in study

Caregiver Inclusion Criteria:

  • One caregiver must enroll with each patient for either subject to be eligible.
  • Caregivers will be selected by the patient when asked if there is a "significant other, spouse, romantic partner, or adult child with whom you discuss or can be helpful in health-related matters;"
  • Age 50 or older
  • Able to reach and understand English

Caregiver Exclusion Criteria:

  • Caregivers unable to provide consent
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Dyadic Life Review

    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.

    Behavioral: Dyadic Life Review

  • No intervention
    Case-As-Usual

    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.

Interventions

  • BehavioralDyadic Life Review

    DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers.

    Also known as: DLR

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What researchers measure

Primary outcomes

  1. DLR Intervention Enrollment Rate

    Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate.

    Time frame: 18 weeks

  2. DLR Intervention Retention Rate

    Evaluate the feasibility of DLR in older patients and caregivers based on retention rate.

    Time frame: 18 weeks

Secondary outcomes

  1. 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.

    Time frame: 18 weeks

  2. 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.

    Time frame: 18 weeks

  3. 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.

    Time frame: 18 weeks

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Study locations

1 site
  • University of Rochester
    Rochester, New York 14642, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06505122
Lead sponsor
University of Rochester
Responsible party
Lee Kehoe (PhD, University of Rochester) — Principal investigator
First posted
Jul 17, 2024
Start date
May 23, 2025
Primary completion
Oct 31, 2025
Completion
Jan 22, 2026
Last update
Jun 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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