Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
Study Details
Study Description
Brief Summary
This research study is evaluating a psychological intervention for caregivers of patients undergoing stem cell transplantation.
Phase 1 will include a qualitative phase to refine the intervention to specifically target the needs of caregivers
Phase 2 of the trial will transition to an interventional randomization clinical trial
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The purpose of this study is to find out whether a psychological intervention can help caregivers learn effective coping methods during their loved one's transplant process and make the experience of being a caregiver more manageable.
Phase 1 of the project entails using qualitative interviews with caregivers to further refine the intervention. The psychological intervention will take place over the course of a patient transplant in a series of eight sessions. A trained behavioral psychologist will meet with the participant or talk with them over the telephone for 30-45 minutes at a time to discuss the caregiver experience and to help develop effective skills to support the patient as well as the participant over the course of the transplant.
Upon the completion of the sessions, the investigators will have a short, audio-recorded exit interview to obtain the participant's feedback on the intervention. At the participant's convenience, this interview will be conducted in-person or over the phone. The investigators will use the feedback to improve the intervention before further testing its efficacy in phase 2, a randomized clinical trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Psychological Intervention refinement Eight weekly sessions in-person or via telephone Qualitative interviews Feedback from 5-10 caregivers to refine the intervention. |
Behavioral: Qualitative Interviews
phase 1 of the study entail refining the psychological intervention based on caregivers' feedback
|
Outcome Measures
Primary Outcome Measures
- Pilot Qualitative Refinement of the Caregiver Intervention [1 year]
qualitative data to develop and refine the caregiver intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult caregivers (≥18 years) of patients undergoing HCT at MGH.
-
A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for transplant
-
Ability to speak English or able to complete questionnaires with minimum assistance of an interpreter.
Exclusion Criteria:
-
Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression)
-
Other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts general Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 16-522
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Qualitative Refinement |
|---|---|
| Arm/Group Description | this clinical trials.gov report is focused on the qualitative refinement phase of the project. |
| Period Title: Overall Study | |
| STARTED | 6 |
| COMPLETED | 5 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Psychological Intervention Refinement |
|---|---|
| Arm/Group Description | Eight weekly sessions in-person or via telephone Qualitative interviews Feedback from 5-10 caregivers to refine the intervention. Qualitative Interviews: phase 1 of the study entail refining the psychological intervention based on caregivers' feedback |
| Overall Participants | 6 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
55
(6)
|
| Sex/Gender, Customized (Count of Participants) | |
| female |
4
66.7%
|
| male |
2
33.3%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
66.7%
|
| Male |
2
33.3%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
16.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
4
66.7%
|
| More than one race |
1
16.7%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Pilot Qualitative Refinement of the Caregiver Intervention |
|---|---|
| Description | qualitative data to develop and refine the caregiver intervention |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Qualitative Refinement |
|---|---|
| Arm/Group Description | pilot qualitative refinement of intervention |
| Measure Participants | 6 |
| intervention length is feasible |
5
83.3%
|
| session length is appropriate |
5
83.3%
|
| preferred fewer visits |
3
50%
|
| focus on mindfulness is appropriate |
5
83.3%
|
Adverse Events
| Time Frame | qualitative refinement of an intervention, no adverse events reported during the entire study period (1 year). all caregivers were followed for a total of 3 months during the intervention refinement | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Qualitative Refinement | |
| Arm/Group Description | this clinical trials.gov report is focused on the qualitative refinement phase of the project. | |
All Cause Mortality |
||
| Qualitative Refinement | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | |
Serious Adverse Events |
||
| Qualitative Refinement | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Qualitative Refinement | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Areej El-Jawahri |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617-724-4000 |
| ael-jawahri@partners.org |
- 16-522