Hematologic Cancer, Hematologic Malignancy
Conditions
Keywords
Hematologic Cancer, Hematologic Malignancy, Hematopoietic Stem, HCT, Cognitive Behavioral Therapy, CBT
Brief 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).
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.
Interventions
BEHAVIORALCBT for Fatigue
10, individualized counseling sessions with a behavioral health counselor via Zoom platform.
BEHAVIORALUsual Care
Standard transplant care.
Sponsors
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Satisfaction (Open Pilot only) | 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 | At recruitment | The intervention will be deemed feasible if at least 60% of eligible participants are enrolled in the randomized trial. |
| Rate of Retention | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Fatigue | Baseline (pre-randomization) up to 5 month follow-up | 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). |
| Improvement of Quality of Life | Baseline (pre-randomization) up to 5 month follow-up | 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). |
| Improvement of Mood | Baseline (pre-randomization) up to 5 month follow-up | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAshley Nelson, PhD
Massachusetts General Hospital
Outcome results
None listed