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CARE App for Caregivers of Stem Cell Transplant Patients
N/A
Recruiting
Led By Areej El-Jawahri, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days post-hct
Awards & highlights
Study Summary
This trial studies if an app helps caregivers of stem cell transplant patients improve their quality of life.
Who is the study for?
This trial is for adult caregivers of cancer patients undergoing stem cell transplants. Participants must understand and speak English, as the CARE app is English-only. They should be closely involved with the patient, either living together or designated as a caregiver during transplant.Check my eligibility
What is being tested?
The study tests if a mobile application called CARE can help improve life quality for caregivers by providing psychosocial support. Caregivers will use this app alongside usual care methods to see if there's any benefit over standard practices alone.See study design
What are the potential side effects?
Since this intervention involves using an application for emotional and psychological support, no direct medical side effects are expected. However, users may experience stress or emotional discomfort when engaging with the content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 days post hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days post hct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety)
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA)
+2 moreOther outcome measures
Coping as measured by the Measure of Current Status (MOCS)
Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale
Usability of the CARE app using the System Usability Scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CARE AppExperimental Treatment1 Intervention
Participants randomized to the CARE app + usual care will complete the following:
Questionnaires at baseline, Day 10, Day 60, and Day 100 post-HCT
use the CARE app from enrollment up to 60 days post-HCT: the CARE app includes 5 contains 5 modules and a 6th optional module
receive usual care as per HCT practice which entails meeting with a transplant social worker prior to HCT and as needed for extra visits
Group II: Usual CareActive Control1 Intervention
Participants randomized to usual care will complete the following:
Questionnaires at baseline, Day 10, Day 60, and Day 100.
receive usual care as per HCT practice, which entails meeting with a transplant social worker prior to HCT and as needed for extra visits.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,521 Total Patients Enrolled
1 Trials studying Blood Cancers
90 Patients Enrolled for Blood Cancers
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,011 Total Patients Enrolled
Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital
18 Previous Clinical Trials
4,392 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am caring for someone undergoing a stem cell transplant for cancer.I am an adult caregiver for the patient, either living with them or officially designated.
Research Study Groups:
This trial has the following groups:- Group 1: CARE App
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators accepting new participants for this trial at present?
"As per the clinicaltrials.gov listing, this study is no longer enrolling participants; its posting from July 1st 2023 and last update in February of that year confirm this fact. Nevertheless, there are 2500 other medical trials actively looking for patients at present."
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