Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
Study Details
Study Description
Brief Summary
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-III cancer who are receiving chemotherapy. Chemotherapy can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Behavioral Intervention
Receive BBT-CI
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Active Comparator: 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. |
Behavioral: Behavioral Intervention
Receive HEAL
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Mean change in the Insomnia Severity Index (ISI) total score [Baseline to day 42]
The Insomnia Severity Index (ISI) is a validated self-report measure of insomnia. A 5-point Likert Scale of seven questions is used to rate each item (0=no problem; 4=very severe problem), yielding a total score ranging from 0-28 with higher scores indicating higher severity of insomnia. A linear mixed effects analysis of covariance model (ANCOVA) will be used to assess the statistical significance of the differences in mean change between BBT-CI and HEAL.
Secondary Outcome Measures
- Mean change in Sleep Efficiency assessed via Actigraphy [Baseline to day 42]
Actigraphy will assess sleep efficiency, calculated as the percent of total sleep time to time in bed. Higher percentage indicates better sleep efficiency. A linear mixed effects analysis of covariance model (ANCOVA) will be used to assess the statistical significance of the differences in mean change between BBT-CI and HEAL.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be diagnosed with cancer stage I, II or III
-
Be currently receiving any cytotoxic chemotherapy (can be cytotoxic chemotherapy alone or in combination with biologics and/or antibodies)
-
Report sleep disturbance of 10 or greater (sum total of all 7 items) on the Insomnia Severity Index
-
Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
-
Be able to speak, understand and read English to participate in the study assessments and interventions
Exclusion Criteria:
-
Be diagnosed with cancer stage IV
-
Have any type of unstable comorbid medical or psychiatric condition that would prohibit completion of study assessments or intervention per physician or physician's designee
-
Be scheduled to receive active radiation prior to the completion of BBT-CI/HEAL interventions
-
Have a documented or physician's diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
-
Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presently or in the past 30 days. Use of psychotropics and sleep medication are allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heartland NCORP | Decatur | Illinois | United States | 62526 |
| 2 | Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
| 3 | Metro-Minnesota Ncorp | Minneapolis | Minnesota | United States | 55426 |
| 4 | University of Rochester NCORP Research Base | Rochester | New York | United States | 14642 |
| 5 | Saint Vincent Hospital | Green Bay | Wisconsin | United States | 54301 |
Sponsors and Collaborators
- University of Rochester NCORP Research Base
- National Cancer Institute (NCI)
- Massey Cancer Center
Investigators
- Principal Investigator: Oxana Palesh, Massey Cancer Center
- Study Chair: Karen Mustian, University of Rochester NCORP Research Base
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- URCC19185
- NCI-2020-07175
- URCC19185
- URCC-19185
- URCC19185
- R01CA214647
- UG1CA189961