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| ID | Type | Description | Link |
|---|---|---|---|
| T32CA102618 | U.S. NIH Grant/Contract | View source | |
| P30AG064103 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute on Aging (NIA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dyadic Life Review (DLR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to week 14 |
| Mean Change in Unidimensional Relationship Closeness Scale for Caregivers |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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We approached 42 patients for consent. We enrolled 38 individual patients in the DLR Intervention study.
42 patients were approached for consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | DLR Intervention | 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): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data include both patients and caregivers (total N=38). Characteristics were not separated by participant role.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Dyads | week 14 |
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up to 14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cancer Patients and Caregivers (Dyadic Life Review Group) | The Dyadic Life Review (DLR) intervention included cancer patients and their identified caregivers. Each dyad participated in 8 weekly 60-minute sessions via video conference, facilitated by a licensed clinician. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Kehoe, Ph.D. | University of Rochester | (585) 276-7686 | leekehoephd@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2022 | Sep 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2022 | Sep 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline to week 14 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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). | Includes all participants approached for study enrollment (N=38). | Posted | Count of Participants | Participants | Baseline |
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| 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. | Includes all participants who completed the intervention and participated in the qualitative interview. Only 12 out of 38 participants completed the interview. | Posted | Count of Participants | Participants | week 14 |
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| Secondary | 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. | Includes 12 caregivers who completed both baseline and week 14 assessments. Data from patient participants were not collected for this outcome. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both assessments (N=12). Patients were not assessed for this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both assessments (N=12). Patients were not assessed for this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| 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. | Caregivers who completed both assessments (N=12). Data from patients were not collected. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both assessments (N=12). Patients were not assessed. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both assessments (N=12). Patients were not assessed for this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both assessments (N=12). Patients were not assessed. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Overall Number of Participants Analyzed (N=12) reflects caregiver participants only; data were not collected from patient participants for this outcome. | Posted | Mean | Standard Deviation | change in score pre to post intervention | baseline to week 14 |
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| Secondary | 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. | 11 patient-caregiver dyads with complete data (N=22 participants). We analyzed 11 patient distress scores and 11 caregiver distress scores to determine the mean change in the correlation between the patient and caregiver distress scores. One subject did not complete the distress score of the 12 patient and caregiver dyads (24 total subjects) who completed the study, so we analyzed the 11 patients and 11 caregivers (22 subjects) for this outcome. | Posted | Mean | Standard Deviation | change in correlation coefficient (r) | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both baseline and week 14 assessments (N=12). | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both baseline and week 14 assessments (N=12). | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both baseline and week 14 assessments for this domain (N=11). Participants with missing or incomplete data for this domain were not included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both baseline and week 14 assessments for this domain (N=11). Participants with missing or incomplete data for this domain were not included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both baseline and week 14 assessments (N=12). | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both baseline and week 14 assessments for this domain (N=11). Participants with missing or incomplete data for this domain were not included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| Secondary | 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. | Caregivers who completed both baseline and week 14 assessments for this domain (N=11). Participants with missing or incomplete data for this domain were not included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline to week 14 |
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| 38 |
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| 38 |
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| 38 |
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