Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL as measured by the patient report outcome (PRO) of insomnia (i.e., the Insomnia Severity Index) at post-intervention. SECONDARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL on sleep efficiency as measured via ...
PRIMARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL as measured by the patient report outcome (PRO) of insomnia (i.e., the Insomnia Severity Index) at post-intervention. SECONDARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL on sleep efficiency as measured via actigraphy at post intervention. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (BBT-CI): Patients complete face to face/video sessions with a trained staff member over 60 minutes each on day 0 and day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks). Patients also complete phone sessions over 15 minutes each on day 7, day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks), and days 28 and 35. GROUP II (HEAL): Patients complete face to face/video sessions with a trained staff member over 60 minutes each on day 0 and day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks). Patients also complete phone sessions over 15 minutes each on day 7, day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks), and days 28 and 35. After completion of study, patients are followed for up to 6 months.
Tracking Information
- NCT #
- NCT04829539
- Collaborators
- National Cancer Institute (NCI)
- Stanford University
- Investigators
- Principal Investigator: Oxana Palesh Stanford University Study Chair: Karen Mustian University of Rochester NCORP Research Base