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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
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.
University of Rochester Medical Center
Rochester, New York, United States
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
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
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
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.
Time frame: baseline to week 14
Mean Change in Unidimensional Relationship Closeness Scale for Caregivers
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to week 14