Stem Cell Transplant ComplicationsNCT03042715
Psychological Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
An observational study of Stem Cell Transplant Complications, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- Qualitative Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 1 Aug 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts general Hospital
Boston, Massachusetts, 02114
About this study
Official title: Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
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
Read the 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.
- Conditions
- Stem Cell Transplant Complications
- Being tested
- Qualitative Interviews
- Keywords
- Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewsBehavioural
phase 1 of the study entail refining the psychological intervention based on caregivers' feedback
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention refinement | * Eight weekly sessions in-person or via telephone
* Qualitative interviews
* Feedback from 5-10 caregivers to refine the intervention. Receives: Behavioral: Qualitative Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot Qualitative Refinement of the Caregiver Intervention
qualitative data to develop and refine the caregiver intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start6 Mar 2017
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042715
- Sponsor's protocol ID
- 16-522
- Status last verified
- Aug 2021
- First submitted
- 28 Jan 2017
- Last updated
- 1 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
- ClinicalTrials.gov ID
- NCT03042715
- Acronym / sponsor ID
- 16-522
- Conditions
- Stem Cell Transplant Complications
- Keywords
- Supportive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention refinement | – | Behavioral: Qualitative Interviews* Eight weekly sessions in-person or via telephone * Qualitative interviews * Feedback from 5-10 caregivers to refine the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative Interviewsphase 1 of the study entail refining the psychological intervention based on caregivers' feedback | Behavioural | Psychological Intervention refinement |
Primary outcome
Pilot Qualitative Refinement of the Caregiver Intervention
Time frame: 1 year
qualitative data to develop and refine the caregiver intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant Complications, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot Qualitative Refinement of the Caregiver Intervention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.