Cancer, AdvancedDLR PilotNCT05200572
Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers
A study testing Dyadic Life Review (DLR) in people with Cancer, Advanced and Cognitive Impairment, Mild, 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 telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with patients and caregivers of older adults with advanced cancer, including those with also Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cancer, Advanced, Cognitive Impairment, Mild
- What is being tested?
- Dyadic Life Review (DLR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 24 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score >14.5 will define ability to independently provide informed consent.
- Eligible patients have Stage III or IV cancer of any type
- Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of <26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.
- Able to read and understand English
Patient Exclusion Criteria:
- Patients scoring <14.5 on the UBACC
- Unable to identify caregiver to participate in study
Caregiver Inclusion Criteria:
- One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.
- Caregivers will be selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
- Age 50 or older
- Ability to provide consent
- Proficient in English
Caregiver Exclusion Criteria
- Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers
The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with patients and caregivers of older adults with advanced cancer, including those with also Mild Cognitive Impairment (MCI). The study will enroll aim to enroll 20 dyads (pairs) of patients and caregivers (40 total subjects).
- Conditions
- Cancer, Advanced, Cognitive Impairment, Mild
- Being tested
- Dyadic Life Review (DLR)
- Medical subject headings
- Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Life Review (DLR)Behavioural
DLR will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Each session will facilitate a recall of each phase of life: childhood, adolescence, young adulthood, mid-life, earlier later life, and later life. While together, the patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life.
| Study group | Role | What they receive |
|---|---|---|
| Total subjects | Experimental | We will enroll dyads (defined as a pair of two people). The dyads are made up of a patient with cancer and their caregiver. The patient and caregiver dyad will go through the Dyadic Life Review intervention together. Dyadic Life Review will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Both patients and caregivers will each complete their own measures before and after completing the Dyadic Life Review intervention. Receives: Behavioral: Dyadic Life Review (DLR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Dyads That Complete the Study
The number of participants that complete the entire study procedures out of the number of participants enrolled in the study. The study consisted of one patient and one caregiver (defined as a dyad) that completed the study procedures together), therefore there were 19 dyads enrolled in the study or 38 participants. The proportion of participants that completed the study was determined out of the 19 dyads enrolled.
Measured: week 14
Proportion of Participants That Consent Who Are Approached for the Study
The number of participants who consented for the study out of the number of eligible participants who were approached and asked if they would like to be in the study. This outcome measures the proportion of potential participants approached who provided informed consent to participate in the Dyadic Life Review (DLR) study. A total of 42 patients were approached, and 38 provided informed consent to participate.The proportion was calculated as the number who consented divided by the total number approached (38 ÷ 42 × 100 = 90.5 percent).
Measured: Baseline
Number of Participants Who State the Intervention is Acceptable During a Qualitative Interview
The proportion of participants who completed the full study intervention and indicated that the intervention was acceptable during post-intervention qualitative interviews. Acceptability was assessed only among participants who completed all study sessions.
Measured: week 14
Secondary outcomes (16)
Mean Change in the UCLA Loneliness Score for Caregivers
UCLA Loneliness Scale assesses perceived loneliness on a 0-10 scale, with higher scores indicating greater loneliness. Mean change was calculated as week 14 score minus baseline score for caregivers who completed the measure.
Measured: baseline to week 14
Mean Change in Unidimensional Relationship Closeness Scale for Caregivers
This measures the quality of the relationship with the 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. The scale of this instrument ranges from 1 to 7 with higher scores indicating more closeness. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Mean Change in Perceived Stress Scale for Caregivers
Measures perceived stress, scale 0-40, higher scores indicate greater stress. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.
Measured: baseline to week 14
Mean Change in Caregiver Reaction Scale for Caregivers
Items assess both positive and negative aspects of caregiving. Subscales: role captivity, overload, relational deprivation, competence, personal gain, family beliefs, family conflict, job conflict. The scale ranges from 0 to 24 with higher scores indicating a more negative caregiver experience. Preliminary evidence for the validity and reliability of the Caregiver Reaction Scale. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.
Measured: baseline to week 14
Mean Change in Geriatric Depression Scale for Caregivers
The purpose of this scale is to identify the clinical threshold of depression in older adults. The scale ranges from 0 to 15 with higher scores indicating worse depression. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.
Measured: baseline to week 14
Mean Change in Distress Thermometer and Problem List for Caregivers
This tool is a 10-point self-report measure to capture distress and identify a list of sources of that distress. The scale ranges from 0-10 with higher scores indicating more distress. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.
Measured: baseline to week 14
Mean Change in Dyadic Adjustment Scale-7 for Caregivers
This is a 7-item measure to assess relationship quality that ranges from 0-36 with higher scores indicating positive relationship quality. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Mean Change in Dyadic Support Questionnaire For Caregivers
18-item measure assessing perceived received and provided support. Scale 0-145, higher scores indicate better dyadic coping. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.
Measured: baseline to week 14
Mean Change in the Correlation Between Patient and Caregiver Distress
Distress measured using Distress Thermometer (0-10, higher = more distress). Pearson correlation coefficient between patient and caregiver distress scores calculated at baseline and week 14; mean change = week 14 minus baseline.
Measured: baseline to week 14
Mean Change in PROMIS29 Depression Domain For Caregivers
Patient-Reported Outcomes Measurement Information System 29-item profile (PROMIS29) - Depression Domain. Scores range from 0-10, with higher scores indicating worse depression. Mean change was calculated as week 14 minus baseline. Mean change calculated as week 14 minus baseline for caregivers who completed both assessments.
Measured: baseline to week 14
Mean Change in PROMIS29 Anxiety Domain For Caregivers
PROMIS29 - Anxiety Domain. Scores range from 0-10, with higher scores indicating worse anxiety. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Mean Change in PROMIS29 Physical Function Domain For Caregivers
PROMIS29 - Physical Function Domain. Scores range from 0-10, with higher scores indicating worse physical function. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Mean Change in PROMIS29 Pain Interference Domain For Caregivers
PROMIS29 - Pain Interference Domain. Scores range from 0-10, with higher scores indicating more pain interference. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Mean Change in PROMIS29 Fatigue Domain For Caregivers
PROMIS29 - Fatigue Domain. Scores range from 0-10, with higher scores indicating worse fatigue. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Mean Change in PROMIS29 Sleep Disturbance Domain For Caregivers
PROMIS29 - Sleep Disturbance Domain. Scores range from 0-10, with higher scores indicating worse sleep disturbance. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Mean Change in PROMIS29 Ability to Participate in Social Roles Domain For Caregivers
PROMIS29 - Ability to Participate in Social Roles Domain. Scores range from 0-10, with higher scores indicating worse social role participation. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.
Measured: baseline to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start28 Mar 2022
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer, AdvancedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lee Kehoe, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200572
- Sponsor's protocol ID
- STUDY00006662
- Other IDs
- T32CA102618, P30AG064103
- Acronym
- DLR Pilot
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2022
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers
- ClinicalTrials.gov ID
- NCT05200572
- Acronym / sponsor ID
- DLR Pilot / STUDY00006662
- Conditions
- Cancer, Advanced, Cognitive Impairment, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Aging (NIA)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 25 Nov 2025
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 telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with patients and caregivers of older adults with advanced cancer, including those with also Mild Cognitive Impairment (MCI). The study will enroll aim to enroll 20 dyads (pairs) of patients and caregivers (40 total subjects).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total subjects | Experimental | Behavioral: Dyadic Life Review (DLR)We will enroll dyads (defined as a pair of two people). The dyads are made up of a patient with cancer and their caregiver. The patient and caregiver dyad will go through the Dyadic Life Review intervention together. Dyadic Life Review will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Both patients and caregivers will each complete their own measures before and after completing the Dyadic Life Review intervention. |
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 Review (DLR)DLR will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Each session will facilitate a recall of each phase of life: childhood, adolescence, young adulthood, mid-life, earlier later life, and later life. While together, the patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life. | Behavioural | Total subjects |
Primary outcome
Proportion of Dyads That Complete the Study
Time frame: week 14
The number of participants that complete the entire study procedures out of the number of participants enrolled in the study. The study consisted of one patient and one caregiver (defined as a dyad) that completed the study procedures together), therefore there were 19 dyads enrolled in the study or 38 participants. The proportion of participants that completed the study was determined out of the 19 dyads enrolled.
Proportion of Participants That Consent Who Are Approached for the Study
Time frame: Baseline
The number of participants who consented for the study out of the number of eligible participants who were approached and asked if they would like to be in the study. This outcome measures the proportion of potential participants approached who provided informed consent to participate in the Dyadic Life Review (DLR) study. A total of 42 patients were approached, and 38 provided informed consent to participate.The proportion was calculated as the number who consented divided by the total number approached (38 ÷ 42 × 100 = 90.5 percent).
Number of Participants Who State the Intervention is Acceptable During a Qualitative Interview
Time frame: week 14
The proportion of participants who completed the full study intervention and indicated that the intervention was acceptable during post-intervention qualitative interviews. Acceptability was assessed only among participants who completed all study sessions.
16 secondary outcomes
Mean Change in the UCLA Loneliness Score for Caregivers
Time frame: baseline to week 14
Mean Change in Unidimensional Relationship Closeness Scale for Caregivers
Time frame: baseline to week 14
Mean Change in Perceived Stress Scale for Caregivers
Time frame: baseline to week 14
Mean Change in Caregiver Reaction Scale for Caregivers
Time frame: baseline to week 14
Mean Change in Geriatric Depression Scale for Caregivers
Time frame: baseline to week 14
Mean Change in Distress Thermometer and Problem List for Caregivers
Time frame: baseline to week 14
Mean Change in Dyadic Adjustment Scale-7 for Caregivers
Time frame: baseline to week 14
Mean Change in Dyadic Support Questionnaire For Caregivers
Time frame: baseline to week 14
Mean Change in the Correlation Between Patient and Caregiver Distress
Time frame: baseline to week 14
Mean Change in PROMIS29 Depression Domain For Caregivers
Time frame: baseline to week 14
Mean Change in PROMIS29 Anxiety Domain For Caregivers
Time frame: baseline to week 14
Mean Change in PROMIS29 Physical Function Domain For Caregivers
Time frame: baseline to week 14
Mean Change in PROMIS29 Pain Interference Domain For Caregivers
Time frame: baseline to week 14
Mean Change in PROMIS29 Fatigue Domain For Caregivers
Time frame: baseline to week 14
Mean Change in PROMIS29 Sleep Disturbance Domain For Caregivers
Time frame: baseline to week 14
Mean Change in PROMIS29 Ability to Participate in Social Roles Domain For Caregivers
Time frame: baseline to week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 (DLR) in people with Cancer, Advanced and Cognitive Impairment, Mild, 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Dyads That Complete the Study (time frame: week 14). 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 25 Nov 2025.