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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to assess whether a cognitive-behavioral therapy (CBT) for fatigue intervention is acceptable, feasible, and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant (HCT).
This research is being done to determine whether a cognitive-behavioral therapy (CBT) for fatigue intervention is feasible and effective at managing fatigue and improving quality of life in patients following hematopoietic stem cell transplant.
An open pilot of 6 participants will precede the randomized controlled trial. Study procedures for the open pilot include screening for eligibility, intervention Zoom sessions, questionnaires, and exit interviews with study staff.
Patients participating in the subsequent randomized controlled trial will be randomized into one of two study groups: CBT for fatigue intervention versus usual care.Study procedures include screening for eligibility, intervention Zoom sessions (intervention arm) or receipt of informational materials about fatigue (usual care arm), and completion of study questionnaires (after consent but before randomization and at approximately 3 and 5 months post-randomization).
This research study is expected to last about 3 years. It is expected about 66 people will take part in this research study.
The National Heart, Lung, and Blood Institute of the National Institute of Health is providing funding for this project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for Fatigue Program | Experimental | Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined:
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| Usual Care | Active Comparator | Screening for eligibility will use the Fatigue Symptoms Inventory (FSI) average severity item over the prior week. Scores of ≥4 of 0-10 will be invited to participate. 30 participants will be enrolled and will complete study procedures as outlined:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT for Fatigue | Behavioral | 10, individualized counseling sessions with a behavioral health counselor via Zoom platform. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Satisfaction (Open Pilot only) | Acceptability is defined by at least 80% of participants reporting satisfaction on the Client Satisfaction Questionnaire (range 8-32, with higher scores representing higher satisfaction). | 3 month follow-up |
| Rate of Enrollment | The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial. | At recruitment |
| Rate of Retention | The intervention will be deemed feasible if at least 70% of participants are retained in both arms of the randomized trial. | Baseline (pre-randomization) up to 5 month follow-up |
| Rate of Intervention Completion | The intervention will be deemed feasible if at least 70% of participants enrolled complete at least 70% of intervention sessions of the randomized trial. | Baseline (pre-randomization) up to 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Fatigue | Fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F). Longitudinal differences in fatigue will be investigated between study groups (FACIT-F score range 0-52, with lower scores indicating greater fatigue). | Baseline (pre-randomization) up to 5 month follow-up |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Nelson, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02215 | United States |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2025 | Jun 3, 2026 | ICF_000.pdf |
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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 | Standard transplant care. |
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| Improvement of Quality of Life |
Quality of life will be assessed with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT). Longitudinal differences in quality of life will be assessed between study groups (FACT-BMT score range 0-164, with higher scores indicating better quality of life). |
| Baseline (pre-randomization) up to 5 month follow-up |
| Improvement of Mood | Improvement in anxiety and depression symptoms will be assessed with the PROMIS Anxiety and Depression Scales. Longitudinal differences in anxiety and depression symptoms will be assessed between study groups (PROMIS anxiety and depression scale scores range 8-40, with higher scores indicating worse anxiety and depression symptoms). | Baseline (pre-randomization) up to 5 month follow-up |