Hematologic CancerNCT05715047
Intervention for Fatigue in HCT Recipients
A study testing CBT for Fatigue in people with Hematologic Cancer and Hematologic Malignancy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Cancer, Hematologic Malignancy
- What is being tested?
- CBT for Fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (≥ 18 years)
- have the ability to speak and read English
- have undergone autologous or allogeneic transplant > 6 months prior to enrollment
- no evidence of disease relapse requiring therapy
- no new other malignancy requiring therapy after transplant
- report moderate to severe fatigue in the past week (FSI average severity item rating ≥ 4 of 0-10)
- are currently receiving their care at the MGH Blood and Marrow Transplant Clinic
Who cannot join
- Patients with active cognitive impairment or uncontrolled psychiatric illness such as schizophrenia that the treating clinician believes prohibits informed consent or participation in the intervention
- Patients already receiving CBT care
- Patients living with untreated sleep apnea
- Patients with hypoxemia requiring oxygen supplementation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
About this study
Official title: Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
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).
Read the detailed description
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.
- Conditions
- Hematologic Cancer, Hematologic Malignancy
- Being tested
- CBT for Fatigue, Usual Care
- Keywords
- Hematologic Cancer, Hematologic Malignancy, Hematopoietic Stem, HCT, Cognitive Behavioral Therapy, CBT
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for FatigueBehavioural
10, individualized counseling sessions with a behavioral health counselor via Zoom platform.
Usual CareBehavioural
Standard transplant care.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* Baseline questionnaires.
* 10 intervention sessions.
* Questionnaires and surveys 3 and 5 months after enrollment. Receives: Behavioral: CBT for Fatigue |
| 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:
* Baseline questionnaires.
* Receive adapted material from the MGH Bone Marrow Transplant Survivorship program outlining common contributors to fatigue after transplant and recommendations for management.
* Questionnaires and surveys 3 and 5 months after enrollment. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-randomization) up to 3 month follow-up
Secondary outcomes (3)
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).
Measured: Baseline (pre-randomization) up to 5 month follow-up
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).
Measured: 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).
Measured: Baseline (pre-randomization) up to 5 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start29 Nov 2023
- Primary completion24 Sep 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ashley M. Nelson, PhD, Massachusetts General Hospital
- Investigators
- Ashley Nelson, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715047
- Sponsor's protocol ID
- 22-513
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05715047
- Acronym / sponsor ID
- 22-513
- Conditions
- Hematologic Cancer, Hematologic Malignancy
- Keywords
- Hematologic Cancer, Hematologic Malignancy, Hematopoietic Stem, HCT, Cognitive Behavioral Therapy, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for Fatigue Program | Experimental | Behavioral: CBT for FatigueScreening 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: * Baseline questionnaires. * 10 intervention sessions. * Questionnaires and surveys 3 and 5 months after enrollment. |
| Usual Care | Active comparator | Behavioral: Usual CareScreening 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: * Baseline questionnaires. * Receive adapted material from the MGH Bone Marrow Transplant Survivorship program outlining common contributors to fatigue after transplant and recommendations for management. * Questionnaires and surveys 3 and 5 months after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult patients (≥ 18 years)
- have the ability to speak and read English
- have undergone autologous or allogeneic transplant > 6 months prior to enrollment
- no evidence of disease relapse requiring therapy
- no new other malignancy requiring therapy after transplant
Key exclusion criteria (4 listed)
- Patients with active cognitive impairment or uncontrolled psychiatric illness such as schizophrenia that the treating clinician believes prohibits informed consent or participation in the intervention
- Patients already receiving CBT care
- Patients living with untreated sleep apnea
- Patients with hypoxemia requiring oxygen supplementation
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 |
|---|---|---|
| CBT for Fatigue10, individualized counseling sessions with a behavioral health counselor via Zoom platform. | Behavioural | CBT for Fatigue Program |
| Usual CareStandard transplant care. | Behavioural | Usual Care |
Primary outcome
Rate of Satisfaction (Open Pilot only)
Time frame: 3 month follow-up
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).
Rate of Enrollment
Time frame: At recruitment
The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial.
Rate of Retention
Time frame: Baseline (pre-randomization) up to 5 month follow-up
The intervention will be deemed feasible if at least 70% of participants are retained in both arms of the randomized trial.
Rate of Intervention Completion
Time frame: Baseline (pre-randomization) up to 3 month follow-up
The intervention will be deemed feasible if at least 70% of participants enrolled complete at least 70% of intervention sessions of the randomized trial.
3 secondary outcomes
Improvement of Fatigue
Time frame: Baseline (pre-randomization) up to 5 month follow-up
Improvement of Quality of Life
Time frame: Baseline (pre-randomization) up to 5 month follow-up
Improvement of Mood
Time frame: Baseline (pre-randomization) up to 5 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Ashley Nelson, PhD 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 CBT for Fatigue in people with Hematologic Cancer and Hematologic Malignancy, 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 7 inclusion and 4 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 5 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Satisfaction (Open Pilot only) (time frame: 3 month follow-up). The study lists 4 primary outcomes in all. 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 5 Jun 2026.