Recruitment

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