CancerNCT07796347
Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Alzheimer's Disease and Related Dementias 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 evaluate the efficacy of Dyadic Life Review (DLR) therapy for reducing caregiver distress, measured by caregiver burden to capture the multifaceted experience of distress, among older adults with advanced cancer and cognitive impairment and their caregivers. 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
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 28 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥65
- Stage III or IV cancer diagnosis, of any type
- The Montreal Cognitive Assessment (MoCA) in-person or MoCA-telephone version ≥15
- Katz Activities of Daily Living (ADL) ≥5
- Able to read and understand English
- Be able to provide informed consent (as measured by UBACC) or have a Legally Authorized Representative to provide informed consent, which can include the participating caregiver.
Show all 15Show fewer
- Caregiver Inclusion Criteria:
- Age 50 or older
- Caregivers are defined is a "significant other, spouse, romantic partner, or adult child with whom you discuss or who can be helpful in health-related matters;"
- Modified Caregiver Strain Index ≥ 5
- Able to read and understand English
- Patient Exclusion Criteria:
- No caregiver willing to participate in the study
- Caregiver Exclusion Criteria:
- Caregivers unable to provide consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Alzheimer's Disease and Related Dementias (ADRD) and Their Caregivers
The purpose of this study is to evaluate the efficacy of Dyadic Life Review (DLR) therapy for reducing caregiver distress, measured by caregiver burden to capture the multifaceted experience of distress, among older adults with advanced cancer and cognitive impairment and their caregivers.
Read the detailed description
The purpose of this study is to evaluate the efficacy of Dyadic Life Review (DLR) therapy for reducing caregiver distress, measured by caregiver burden to capture the multifaceted experience of distress, among older adults with advanced cancer and cognitive impairment and their caregivers. This randomized controlled trial will enroll dyads and compare DLR to a waitlist control condition in which participants receive usual care and are offered DLR following completion of study procedures. In addition to examining the effects of DLR on caregiver burden, the study will explore whether DLR improves dyadic coping and relationship quality within the patient-caregiver relationship and identify patient and caregiver characteristics associated with greater intervention benefit. Findings from this study will provide preliminary evidence regarding the efficacy of DLR and inform future intervention development and implementation for older adults with cancer and cognitive impairment and their caregivers.
- 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
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 |
| Care-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.
Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Stress Burden Score at Week 18
The subjective stress burden domain of the Montgomery Borgatta Caregiver Burden Scale assesses stress experienced by the caregiver in relation to caregiving. Scores range from 4 to 20, with higher scores indicating greater burden.
Measured: Baseline and 18 weeks
2. Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Demand Burden Score at Week 18
The subjective demand burden domain of the Montgomery Borgatta Caregiver Burden Scale assesses the caregiver's perceived demands associated with caregiving. Scores range from 4 to 20, with higher scores indicating greater burden.
Measured: Baseline and 18 weeks
Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Objective Burden Score at Week 18
The Montgomery Borgatta Caregiver Burden Scale is a 14 item self report measure of caregiver burden. The objective burden domain assesses the impact of caregiving activities on the caregiver. Scores range from 0 to 30, with higher scores indicating greater burden.
Measured: Baseline and 18 weeks
Secondary outcomes (2)
Change From Baseline in Unidimensional Relationship Closeness Scale Score at Week 18
The Unidimensional Relationship Closeness Scale is a 12 item self report measure assessing relationship closeness between the participant and family member. Each item is rated on a 7 point Likert scale. Total scores range from 12 to 84, with higher scores indicating greater relationship closeness.
Measured: Baseline and 18 weeks
Change From Baseline in Dyadic Adjustment Scale Score at Week 18
The Dyadic Adjustment Scale is a 7 item self report measure assessing dyadic relationship quality and adjustment. Scores range from 0 to 36, with higher scores indicating greater relationship adjustment.
Measured: Baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Jul 2030 (estimated)
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lee Kehoe, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796347
- Sponsor's protocol ID
- UOCPC26064
- Other IDs
- 1K23AG086622-01A1
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Alzheimer's Disease and Related Dementias (ADRD) and Their Caregivers
- ClinicalTrials.gov ID
- NCT07796347
- Acronym / sponsor ID
- UOCPC26064
- Conditions
- Cancer
- Keywords
- Older Adults, Geriatric Oncology, Caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Jul 2030 (estimated)
- First posted
- 1 Sep 2026 (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 evaluate the efficacy of Dyadic Life Review (DLR) therapy for reducing caregiver distress, measured by caregiver burden to capture the multifaceted experience of distress, among older adults with advanced cancer and cognitive impairment and their caregivers.
Detailed description
The purpose of this study is to evaluate the efficacy of Dyadic Life Review (DLR) therapy for reducing caregiver distress, measured by caregiver burden to capture the multifaceted experience of distress, among older adults with advanced cancer and cognitive impairment and their caregivers. This randomized controlled trial will enroll dyads and compare DLR to a waitlist control condition in which participants receive usual care and are offered DLR following completion of study procedures. In addition to examining the effects of DLR on caregiver burden, the study will explore whether DLR improves dyadic coping and relationship quality within the patient-caregiver relationship and identify patient and caregiver characteristics associated with greater intervention benefit. Findings from this study will provide preliminary evidence regarding the efficacy of DLR and inform future intervention development and implementation for older adults with cancer and cognitive impairment and their caregivers.
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. |
| Care-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
Key inclusion criteria (15 listed)
- Age ≥65
- Stage III or IV cancer diagnosis, of any type
- The Montreal Cognitive Assessment (MoCA) in-person or MoCA-telephone version ≥15
- Katz Activities of Daily Living (ADL) ≥5
- Able to read and understand English
Key exclusion criteria (0 listed)
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 ReviewDLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers. | Behavioural | Dyadic Life Review |
Primary outcome
Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Stress Burden Score at Week 18
Time frame: Baseline and 18 weeks
The subjective stress burden domain of the Montgomery Borgatta Caregiver Burden Scale assesses stress experienced by the caregiver in relation to caregiving. Scores range from 4 to 20, with higher scores indicating greater burden.
2. Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Demand Burden Score at Week 18
Time frame: Baseline and 18 weeks
The subjective demand burden domain of the Montgomery Borgatta Caregiver Burden Scale assesses the caregiver's perceived demands associated with caregiving. Scores range from 4 to 20, with higher scores indicating greater burden.
Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Objective Burden Score at Week 18
Time frame: Baseline and 18 weeks
The Montgomery Borgatta Caregiver Burden Scale is a 14 item self report measure of caregiver burden. The objective burden domain assesses the impact of caregiving activities on the caregiver. Scores range from 0 to 30, with higher scores indicating greater burden.
2 secondary outcomes
Change From Baseline in Unidimensional Relationship Closeness Scale Score at Week 18
Time frame: Baseline and 18 weeks
Change From Baseline in Dyadic Adjustment Scale Score at Week 18
Time frame: Baseline and 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
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?
The sponsor lists 15 inclusion and 0 exclusion criteria. 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: opening soon, as of the sponsor's last update on 1 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Kehoe (585-275-4625, Lee_Kehoe@URMC.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Stress Burden Score at Week 18 (time frame: Baseline and 18 weeks). The study lists 3 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 1 Sep 2026.