Stem Cell Transplant Complications
Conditions
Keywords
Supportive Care
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
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.
Interventions
BEHAVIORALQualitative Interviews
phase 1 of the study entail refining the psychological intervention based on caregivers' feedback
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pilot Qualitative Refinement of the Caregiver Intervention | 1 year | qualitative data to develop and refine the caregiver intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psychological Intervention Refinement * 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 | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Psychological Intervention Refinement |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
| Sex/Gender, Customized female | 4 Participants |
| Sex/Gender, Customized male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Pilot Qualitative Refinement of the Caregiver Intervention
qualitative data to develop and refine the caregiver intervention
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Qualitative Refinement | Pilot Qualitative Refinement of the Caregiver Intervention | intervention length is feasible | 5 Participants |
| Qualitative Refinement | Pilot Qualitative Refinement of the Caregiver Intervention | session length is appropriate | 5 Participants |
| Qualitative Refinement | Pilot Qualitative Refinement of the Caregiver Intervention | preferred fewer visits | 3 Participants |
| Qualitative Refinement | Pilot Qualitative Refinement of the Caregiver Intervention | focus on mindfulness is appropriate | 5 Participants |