Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological Intervention refinement |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualitative Interviews | Behavioral | phase 1 of the study entail refining the psychological intervention based on caregivers' feedback |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pilot Qualitative Refinement of the Caregiver Intervention | qualitative data to develop and refine the caregiver intervention | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Caregivers will be recruited during the patient transplant consent visit, which typically occurs 2-4 weeks prior to admission for HCT. Caregivers are required to attend the HCT consent visit with the patient.
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Qualitative Refinement | this clinical trials.gov report is focused on the qualitative refinement phase of the project. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Psychological Intervention Refinement |
Qualitative Interviews: phase 1 of the study entail refining the psychological intervention based on caregivers' feedback |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pilot Qualitative Refinement of the Caregiver Intervention | qualitative data to develop and refine the caregiver intervention | Posted | Count of Participants | Participants | 1 year |
|
|
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
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Qualitative Refinement | this clinical trials.gov report is focused on the qualitative refinement phase of the project. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Areej El-Jawahri | Massachusetts General Hospital | 617-724-4000 | ael-jawahri@partners.org |
Not provided
| 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 | Aug 29, 2018 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
Not provided
Not provided