CancerNCT03328663
Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant
A study testing CARE and Standard Transplant Care in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is evaluating the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- CARE and Standard Transplant Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 30 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adult caregivers (≥18 years) of patients undergoing autologous or allogeneic HCT at MGH, and they must attend the HCT consent visit with the patient.
- 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 or other co-morbid disease, which the primary oncologist 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: Randomized Trial of a Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
This research study is evaluating the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant.
Read the detailed description
The purpose of this study is to find out whether a psychological intervention can make the experience of being a caregiver more manageable by improving the participant's quality of life, mood, and caregiving burden during the participant's loved one's transplant process.
The psychological intervention will entail six visits with a trained clinician and will take place during the first three months of the participant's loved ones' transplant process. A trained behavioral psychologist or social worker will meet with the participant or talk with the participant over the telephone or video conference for 45 minutes at a time to discuss the participant's caregiver experience and to help the participant develop effective skills to support the participant's loved one as well as participant over the course of the transplant.
The study will use a series of questionnaires to measure the participant's quality of life, mood, and overall caregiving burden. Study questionnaires will be completed in the hospital or clinic. The participant will also have the option of completing these questionnaires remotely through a secure web link, over the telephone, or in a mailed paper copy.
- Conditions
- Cancer
- Being tested
- CARE, Standard Transplant Care
- Keywords
- Cancer Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREOther
Promote effective coping and reduce caregiving burden.
Standard Transplant CareOther
Standard cared administered by the hospital.
| Study group | Role | What they receive |
|---|---|---|
| CARE intervention | Experimental | * 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 Receives: Other: CARE |
| Standard transplant care | Active comparator | * Standard Transplant Care
* Social work consults to help caregivers only upon request Receives: Other: CARE; Other: Standard Transplant Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention (Feasibility Description Below)
Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits
Measured: 15 months
Secondary outcomes (5)
Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms
we will compare caregiver QOL as measured by CarGOQOL between study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
Measured: day 60
Compare Caregiving Burden (CRA) Between the Study Arms
we 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
Measured: day 60
Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms
We 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.
Measured: day 60
Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms
We 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.
Measured: day 60
Compare Perceived Coping Skills (MOCS) Between the Study Arms
Compare 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
Measured: day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Jan 2018
- Primary completion1 Apr 2019
- Study completion30 Dec 2024
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 CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- 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
- NCT03328663
- Sponsor's protocol ID
- 17-476
- Other IDs
- CA087723
- Status last verified
- Mar 2026
- First submitted
- 29 Oct 2017
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
- ClinicalTrials.gov ID
- NCT03328663
- Acronym / sponsor ID
- 17-476
- Conditions
- Cancer
- Keywords
- Cancer Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 20 Mar 2026
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 the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant.
Detailed description
The purpose of this study is to find out whether a psychological intervention can make the experience of being a caregiver more manageable by improving the participant's quality of life, mood, and caregiving burden during the participant's loved one's transplant process.
The psychological intervention will entail six visits with a trained clinician and will take place during the first three months of the participant's loved ones' transplant process. A trained behavioral psychologist or social worker will meet with the participant or talk with the participant over the telephone or video conference for 45 minutes at a time to discuss the participant's caregiver experience and to help the participant develop effective skills to support the participant's loved one as well as participant over the course of the transplant.
The study will use a series of questionnaires to measure the participant's quality of life, mood, and overall caregiving burden. Study questionnaires will be completed in the hospital or clinic. The participant will also have the option of completing these questionnaires remotely through a secure web link, over the telephone, or in a mailed paper copy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARE intervention | Experimental | Other: CARE* 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 |
| Standard transplant care | Active comparator | Other: CARE, Other: Standard Transplant Care* Standard Transplant Care * Social work consults to help caregivers only upon request |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult caregivers (≥18 years) of patients undergoing autologous or allogeneic HCT at MGH, and they must attend the HCT consent visit with the patient.
- 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 (1 listed)
- Significant uncontrolled psychiatric or other co-morbid disease, which the primary oncologist 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 |
|---|---|---|
| CAREPromote effective coping and reduce caregiving burden. | Other | CARE intervention, Standard transplant care |
| Standard Transplant CareStandard cared administered by the hospital. | Other | Standard transplant care |
Primary outcome
Feasibility of the Intervention (Feasibility Description Below)
Time frame: 15 months
Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits
5 secondary outcomes
Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms
Time frame: day 60
Compare Caregiving Burden (CRA) Between the Study Arms
Time frame: day 60
Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms
Time frame: day 60
Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms
Time frame: day 60
Compare Perceived Coping Skills (MOCS) Between the Study Arms
Time frame: day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- 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?
A study testing CARE and Standard Transplant Care in people with Cancer, 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 1 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 20 Mar 2026. 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 20 Mar 2026). 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?
Feasibility of the Intervention (Feasibility Description Below) (time frame: 15 months). 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 20 Mar 2026.