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| ID | Type | Description | Link |
|---|---|---|---|
| CA087723 | Other Grant/Funding Number | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research study is evaluating the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant.
The purpose of this study is to find out whether a psychological intervention can make the experience of being a caregiver more manageable by improving the participant's quality of life, mood, and caregiving burden during the participant's loved one's transplant process.
The psychological intervention will entail six visits with a trained clinician and will take place during the first three months of the participant's loved ones' transplant process. A trained behavioral psychologist or social worker will meet with the participant or talk with the participant over the telephone or video conference for 45 minutes at a time to discuss the participant's caregiver experience and to help the participant develop effective skills to support the participant's loved one as well as participant over the course of the transplant.
The study will use a series of questionnaires to measure the participant's quality of life, mood, and overall caregiving burden. Study questionnaires will be completed in the hospital or clinic. The participant will also have the option of completing these questionnaires remotely through a secure web link, over the telephone, or in a mailed paper copy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARE intervention | Experimental |
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| Standard transplant care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARE | Other | Promote effective coping and reduce caregiving burden. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention (Feasibility Description Below) | Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms | we will compare caregiver QOL as measured by CarGOQOL between study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL | day 60 |
| Compare Caregiving Burden (CRA) Between the Study Arms |
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Inclusion Criteria:
Exclusion Criteria:
• Significant uncontrolled psychiatric or other co-morbid disease, which the primary oncologist believes prohibits the ability to participate in study procedures
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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8 caregivers who were enrolled were never randomized as they became ineligible prior to randomization with the transplant aborted.
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| ID | Title | Description |
|---|---|---|
| FG000 | CARE Intervention |
CARE: Promote effective coping and reduce caregiving burden. |
| FG001 | Standard Transplant Care |
CARE: Promote effective coping and reduce caregiving burden. Standard Transplant Care: Standard cared administered by the hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CARE Intervention |
CARE: Promote effective coping and reduce caregiving burden. |
| 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, Continuous | Median |
| 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 | Feasibility of the Intervention (Feasibility Description Below) | Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits | Participants randomized to the CARE intervention | Posted | Count of Participants | Participants | 15 months |
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Adverse events were collected up to 90 days after transplant
This is a supportive care study in a population at high risk of death. Only adverse events that are thought to be related to the study procedures were collected.
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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 | CARE Intervention |
CARE: Promote effective coping and reduce caregiving burden. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Areej El-Jawahri | Massachusetts General Hospital | 617-724-4000 | ael-jawahri@mgb.org |
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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 | Oct 3, 2016 | Mar 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Standard Transplant Care | Other | Standard cared administered by the hospital. |
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we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA). The CRA ranges from 24-120 with higher scores indicating greater caregiving burden |
| day 60 |
| Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms | We will compare caregiver anxiety use the Hospital Anxiety and Depression Scale (HADS) between the two groups. The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress)). Higher scores on HADS-Anxiety subscale indicate worse anxiety symptoms. | day 60 |
| Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms | We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between study groups. The scale ranges from 0 to 170 with higher scores indicate higher self efficacy. | day 60 |
| Compare Perceived Coping Skills (MOCS) Between the Study Arms | Compare caregiver coping skills using the Measure of Current Status (MOCS) between the study arms. Score ranges from 0-52, with higher scores indicating higher coping skills | day 60 |
| BG001 | Standard Transplant Care |
CARE: Promote effective coping and reduce caregiving burden. Standard Transplant Care: Standard cared administered by the hospital. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms | we will compare caregiver QOL as measured by CarGOQOL between study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL | Posted | Mean | 95% Confidence Interval | score on a scale | day 60 |
|
|
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| Secondary | Compare Caregiving Burden (CRA) Between the Study Arms | we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA). The CRA ranges from 24-120 with higher scores indicating greater caregiving burden | Posted | Mean | 95% Confidence Interval | score on a scale | day 60 |
|
|
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| Secondary | Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms | We will compare caregiver anxiety use the Hospital Anxiety and Depression Scale (HADS) between the two groups. The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress)). Higher scores on HADS-Anxiety subscale indicate worse anxiety symptoms. | Posted | Mean | 95% Confidence Interval | score on a scale | day 60 |
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| Secondary | Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms | We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between study groups. The scale ranges from 0 to 170 with higher scores indicate higher self efficacy. | Posted | Mean | 95% Confidence Interval | score on a scale | day 60 |
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| Secondary | Compare Perceived Coping Skills (MOCS) Between the Study Arms | Compare caregiver coping skills using the Measure of Current Status (MOCS) between the study arms. Score ranges from 0-52, with higher scores indicating higher coping skills | Posted | Mean | 95% Confidence Interval | score on a scale | day 60 |
|
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|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Standard Transplant Care |
CARE: Promote effective coping and reduce caregiving burden. Standard Transplant Care: Standard cared administered by the hospital. | 0 | 47 | 0 | 47 | 0 | 47 |
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