Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment 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.
Detailed description
PRIMARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index (ISI) at post-intervention. SECONDARY OBJECTIVE: I. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at post-intervention. MECHANISTIC OBJECTIVE: I. Examine the efficacy of BBT-CI compared to HEAL for regulating circadian rhythms as measured via actigraphy (i.e., Mesor, Acrophase, Amplitude, I\<O dichotomy index). EXPLORATORY OBJECTIVES: I. Examine potential moderators of BBT-CI effects on insomnia (ISI). II. Examine potential mediators of BBT-CI effects on insomnia (ISI). III. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index at the 6-month follow-up. IV. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at the 6-month follow-up. 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. Patients also complete phone sessions. GROUP II (HEAL): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. After completion of study, patients are followed for up to 6 months.
Interventions
BEHAVIORALBehavioral Intervention
Receive BBT-CI
OTHERElectronic Health Record Review
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
After completion of all baseline assessments, the coordinator will tell the study participant which group they are in but will not reveal which intervention is hypothesized to have a greater effect on insomnia. Both interventions will be presented with equipoise. The investigator and the statistical team will be blinded to the intervention group. The rest of the study staff will not be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age * Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months * Be currently receiving any cancer treatment (surgery alone is excluded) * Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems" * 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
* Have a clinical 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 sleep medications are allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | post intervention | Will evaluate the mean between arm difference in ISI score change from time point baseline to post-intervention. To assess this, will use analysis of covariance model with ISI at post-intervention as the outcome, study arm (group) as a fixed effect and baseline ISI as a covariate. Will test baseline group interaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | post intervention | Will be measured via actigraphy. |
| Circadian phenomena | Up to 6 months post intervention | Circadian phenomena will be measured via actigraphy (Mesor, Acrophase, Amplitude, I \< O dichotomy index). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROxana Palesh, PhD
Massey Cancer Center
Outcome results
None listed