Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers

Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05200572

Acronym

DLR Pilot

Enrollment

Registered

2022-01-20

Start date

2022-03-28

Completion date

2024-05-24

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Advanced, Cognitive Impairment, Mild

Brief 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). The study will enroll aim to enroll 20 dyads (pairs) of patients and caregivers (40 total subjects).

Interventions

BEHAVIORALDyadic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Dyads That Complete the Study	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	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	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.

Secondary

Measure	Time frame	Description
Mean Change in Caregiver Reaction Scale for Caregivers	baseline to week 14	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.
Mean Change in Geriatric Depression Scale for Caregivers	baseline to week 14	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.
Mean Change in Distress Thermometer and Problem List for Caregivers	baseline to week 14	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.
Mean Change in Dyadic Adjustment Scale-7 for Caregivers	baseline to week 14	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.
Mean Change in Dyadic Support Questionnaire For Caregivers	baseline to week 14	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.
Mean Change in the Correlation Between Patient and Caregiver Distress	baseline to week 14	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.
Mean Change in the UCLA Loneliness Score for Caregivers	baseline to week 14	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.
Mean Change in PROMIS29 Anxiety Domain For Caregivers	baseline to week 14	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.
Mean Change in PROMIS29 Physical Function Domain For Caregivers	baseline to week 14	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.
Mean Change in PROMIS29 Pain Interference Domain For Caregivers	baseline to week 14	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.
Mean Change in PROMIS29 Fatigue Domain For Caregivers	baseline to week 14	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.
Mean Change in PROMIS29 Sleep Disturbance Domain For Caregivers	baseline to week 14	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.
Mean Change in PROMIS29 Ability to Participate in Social Roles Domain For Caregivers	baseline to week 14	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.
Mean Change in PROMIS29 Depression Domain For Caregivers	baseline to week 14	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.
Mean Change in Unidimensional Relationship Closeness Scale for Caregivers	baseline to week 14	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.
Mean Change in Perceived Stress Scale for Caregivers	baseline to week 14	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.

Countries

United States

Participant flow

Recruitment details

42 patients were approached for consent.

Pre-assignment details

We approached 42 patients for consent. We enrolled 38 individual patients in the DLR Intervention study.

Participants by arm

Arm	Count
Dyadic Life Review Intervention (Patients and Caregivers) 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. Dyadic Life Review (DLR): Dyadic Life Review (DLR) was delivered to both members of each patient-caregiver dyad. Each dyad completed 8 video sessions facilitated by a licensed clinician. 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.	38
Total	38

Arm

Count

Dyadic Life Review Intervention (Patients and Caregivers)

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. Dyadic Life Review (DLR): Dyadic Life Review (DLR) was delivered to both members of each patient-caregiver dyad. Each dyad completed 8 video sessions facilitated by a licensed clinician. 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	14

Baseline characteristics

Characteristic	Dyadic Life Review Intervention (Patients and Caregivers)
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	36 Participants
Age, Categorical Between 18 and 65 years	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants
Race (NIH/OMB) White	32 Participants
Region of Enrollment United States	38 participants
Sex: Female, Male Female	22 Participants
Sex: Female, Male Male	16 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 38
other Total, other adverse events	0 / 38
serious Total, serious adverse events	0 / 38

Outcome results

Primary

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.

Time frame: week 14

Population: Includes all participants who completed the intervention and participated in the qualitative interview. Only 12 out of 38 participants completed the interview.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cancer Patients	Number of Participants Who State the Intervention is Acceptable During a Qualitative Interview	12 Participants

Primary

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.

Time frame: week 14

Arm	Measure	Value (NUMBER)
Cancer Patients	Proportion of Dyads That Complete the Study	12 Dyads

Primary

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).

Time frame: Baseline

Population: Includes all participants approached for study enrollment (N=38).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cancer Patients	Proportion of Participants That Consent Who Are Approached for the Study	38 Participants

Secondary

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.