CancerDLR RCTNCT06505122
Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
A study testing Dyadic Life Review in people with Cancer, run by University of Rochester at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Dyadic Life Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
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.
- Conditions
- Cancer
- Being tested
- Dyadic Life Review
- Keywords
- Older Adults, Geriatric Oncology, Caregivers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Life ReviewBehavioural
Also called DLR
DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dyadic Life Review |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLR Intervention Enrollment Rate
Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate.
Measured: 18 weeks
DLR Intervention Retention Rate
Evaluate the feasibility of DLR in older patients and caregivers based on retention rate.
Measured: 18 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start23 May 2025
- Primary completion31 Oct 2025
- Study completion22 Jan 2026
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kehoe, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505122
- Sponsor's protocol ID
- UOCPC24051
- Acronym
- DLR RCT
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
- ClinicalTrials.gov ID
- NCT06505122
- Acronym / sponsor ID
- DLR RCT / UOCPC24051
- Conditions
- Cancer
- Keywords
- Older Adults, Geriatric Oncology, Caregivers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic Life Review | Experimental | Behavioral: Dyadic Life ReviewThe 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. |
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic Life ReviewAlso: DLRDLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers. | Behavioural | Dyadic Life Review |
Primary outcome
DLR Intervention Enrollment Rate
Time frame: 18 weeks
Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate.
DLR Intervention Retention Rate
Time frame: 18 weeks
Evaluate the feasibility of DLR in older patients and caregivers based on retention rate.
3 secondary outcomes
Unidimensional Relationship Closeness Scale
Time frame: 18 weeks
Communication Satisfaction Scale
Time frame: 18 weeks
Distress Thermometer
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Life Review in people with Cancer, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLR Intervention Enrollment Rate (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.