Trial Outcomes & Findings for Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant (NCT NCT03328663)
NCT ID: NCT03328663
Last Updated: 2026-03-20
Results Overview
Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
15 months
Results posted on
2026-03-20
Participant Flow
8 caregivers who were enrolled were never randomized as they became ineligible prior to randomization with the transplant aborted.
Participant milestones
| Measure |
CARE Intervention
* Six psychological intervention sessions in-person or via video conferencing conducted by a trained psychologist
* The CARE intervention contain 3 component
* a psychoeducational component to address preparednessmanage expectations, and develop caregiving skills
* a psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertainty
* a self-care component to promote caregiver health and well-being
CARE: Promote effective coping and reduce caregiving burden.
|
Standard Transplant Care
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
COMPLETED
|
42
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Standard Transplant Care
n=47 Participants
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
Total
n=92 Participants
Total of all reporting groups
|
CARE Intervention
n=45 Participants
* Six psychological intervention sessions in-person or via video conferencing conducted by a trained psychologist
* The CARE intervention contain 3 component
* a psychoeducational component to address preparednessmanage expectations, and develop caregiving skills
* a psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertainty
* a self-care component to promote caregiver health and well-being
CARE: Promote effective coping and reduce caregiving burden.
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=151 Participants
|
61 years
n=305 Participants
|
58 years
n=154 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=151 Participants
|
64 Participants
n=305 Participants
|
31 Participants
n=154 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=151 Participants
|
28 Participants
n=305 Participants
|
14 Participants
n=154 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
0 Participants
n=154 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
0 Participants
n=154 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
0 Participants
n=154 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=151 Participants
|
3 Participants
n=305 Participants
|
2 Participants
n=154 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=151 Participants
|
85 Participants
n=305 Participants
|
42 Participants
n=154 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=151 Participants
|
2 Participants
n=305 Participants
|
1 Participants
n=154 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
0 Participants
n=154 Participants
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: Participants randomized to the CARE intervention
Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits
Outcome measures
| Measure |
CARE Interventions
n=45 Participants
Feasibility measure only applies to Care intervention participants receiving the psychological intervention
|
Standard Transplant Care
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
|---|---|---|
|
Feasibility of the Intervention (Feasibility Description Below)
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: day 60we will compare caregiver QOL as measured by CarGOQOL between study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
Outcome measures
| Measure |
CARE Interventions
n=42 Participants
Feasibility measure only applies to Care intervention participants receiving the psychological intervention
|
Standard Transplant Care
n=45 Participants
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
|---|---|---|
|
Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms
|
81.22 score on a scale
Interval 77.69 to 84.74
|
70.96 score on a scale
Interval 67.56 to 74.36
|
SECONDARY outcome
Timeframe: day 60we 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
Outcome measures
| Measure |
CARE Interventions
n=42 Participants
Feasibility measure only applies to Care intervention participants receiving the psychological intervention
|
Standard Transplant Care
n=45 Participants
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
|---|---|---|
|
Compare Caregiving Burden (CRA) Between the Study Arms
|
46.95 score on a scale
Interval 43.62 to 50.29
|
55.06 score on a scale
Interval 51.81 to 58.31
|
SECONDARY outcome
Timeframe: day 60We 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.
Outcome measures
| Measure |
CARE Interventions
n=42 Participants
Feasibility measure only applies to Care intervention participants receiving the psychological intervention
|
Standard Transplant Care
n=45 Participants
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
|---|---|---|
|
Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms
|
3.62 score on a scale
Interval 2.47 to 4.77
|
7.22 score on a scale
Interval 6.11 to 8.33
|
SECONDARY outcome
Timeframe: day 60We 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.
Outcome measures
| Measure |
CARE Interventions
n=42 Participants
Feasibility measure only applies to Care intervention participants receiving the psychological intervention
|
Standard Transplant Care
n=45 Participants
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
|---|---|---|
|
Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms
|
156.20 score on a scale
Interval 150.69 to 161.71
|
147.06 score on a scale
Interval 141.56 to 152.57
|
SECONDARY outcome
Timeframe: day 60Compare 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
Outcome measures
| Measure |
CARE Interventions
n=42 Participants
Feasibility measure only applies to Care intervention participants receiving the psychological intervention
|
Standard Transplant Care
n=45 Participants
* Standard Transplant Care
* Social work consults to help caregivers only upon request
CARE: Promote effective coping and reduce caregiving burden.
Standard Transplant Care: Standard cared administered by the hospital.
|
|---|---|---|
|
Compare Perceived Coping Skills (MOCS) Between the Study Arms
|
36.54 score on a scale
Interval 33.88 to 39.19
|
28.02 score on a scale
Interval 25.41 to 30.64
|
Adverse Events
CARE Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Transplant Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place