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| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
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The goal of this research study is to determine whether a self-administered, psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT).
This is a randomized clinical trial to determine whether a psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT). The CARE app was developed with the goal of addressing the needs of caregivers of HCT recipients.
Participants will be randomized into one of two study groups: CARE app plus Usual Care versus Usual Care.
Participation in this study is expected to last up to 100 days after HCT.
It is expected that about 120 people will take part in this research study.
The Leukemia and Lymphoma Society is supporting this research by providing funding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARE App | Experimental | Participants randomized to the CARE app + usual care will complete the following:
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| Usual Care | Active Comparator | Participants randomized to usual care will complete the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARE Application | Behavioral | Self-administered, psychosocial mobile application comprised of 5 learning modules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | Compare caregiver QOL as measured by the CARGOQOL between the two study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL | up to 60 days post-HCT |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | Compare caregiver QOL as measured by the CARGOQOL between the two study groups longitudinally. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL | up to 100 days post HCT |
| Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) |
| Measure | Description | Time Frame |
|---|---|---|
| Coping as measured by the Measure of Current Status (MOCS) | Comparing caregiver coping as measured by the MOCS between the two study groups. The scale ranges from 0-52 with higher scores indicating higher coping skills | Up to 100 days post-HCT |
| Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale |
Caregiver Inclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40204300 | Derived | Willis KD, Barata A, Freese M, Applebaum AJ, Nelson A, Traeger LN, Horick NK, Rabideau DJ, Temel JS, Greer JA, Jacobs JM, El-Jawahri A. Randomised controlled trial of a psychosocial digital health application to promote coping for caregivers of patients undergoing haematopoietic stem cell transplantation: a study protocol for the BMT-CARE app. BMJ Open. 2025 Apr 8;15(4):e092371. doi: 10.1136/bmjopen-2024-092371. |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Usual Care | Behavioral | Meeting with transplant social worker prior to HCT, consistent with standard-of-care. |
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Compare caregiving burden as measured by the CRA between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden |
| Up to 100 days post HCT |
| Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety) | Compare anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse anxiety symptoms | Up to 100 days post HCT |
| Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) | Compare depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms | Up to 100 days post HCT |
| Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist | Compare post-traumatic stress symptoms as measured by the Post-Traumatic Stress Checklist-Civilian Version between the two groups. The checklist ranges from 17-85 with higher scores indicating worse PTSD Symptoms | Up to 100 days post HCT |
Compare caregiver self-efficacy as measured by the CASE-t between the two study groups. The scale ranges from 0-170 with higher scores indicating better self-efficacy |
| Up to 100 days post-HCT |
| Usability of the CARE app using the System Usability Scale | Assess the usability of the care app (in those receiving the intervention) using the System Usability Scale, which ranges 0-100 with higher scores indicating better usability | up to 60 days post-HCT |