Clinical trial NCT02002533: Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
Official title: Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Stanford University
First posted: 2013-12-06
Enrollment: 71
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.

Detailed description: PRIMARY OBJECTIVES:

I. Determine recruitment rates to the proposed randomized controlled trial (RCT).

II. Determine the rate of intervention adherence. III. Determine the feasibility of training National Cancer Institute (NCI) Community Oncology Research Program (NCORP) clinical research staff to successfully deliver the Brief Behavioral Therapy (BBT) intervention.

SECONDARY OBJECTIVES:

I. Obtain preliminary estimates for the effect of the intervention (compared with control) on insomnia as measured by the Insomnia Severity Index (ISI).

II. Obtain preliminary estimates for the effect of the intervention (compared with control) on sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI).

III. Obtain preliminary estimates for the effect of the intervention (compared with control) on circadian rhythm as measured by the two-oscillator cosinor parameter estimates based on actigraphy data.

IV. Obtain preliminary estimates for the effect of the intervention (compared with control) on heart rate variability (HRV) as measured by the Firstbeat® ambulatory heart-rate monitor (i.e., 1. respiratory sinus arrhythmia-RSA, 2. standard deviation of all normal R-wave to R-wave intervals--SDNN, 3. root mean square of successive differences between adjacent normal R-wave to R-wave intervals--RMSSD, 4. The ratio of low frequency total spectrum power of all NN intervals between .04 to .15 Hertz to high frequency total spectrum power of all NN intervals between .15 to .40 Hertz--LF/HF ratio, and 5. natural log of low frequency total spectrum power of all NN intervals between 0.04 to 0.15Hz.).

TERTIARY OBJECTIVES:

I. Obtain preliminary estimates for the effect of the intervention (compared with control) on quality of life as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) total score and subscales.

II. Obtain preliminary estimates for the effect of the intervention (compared with control) on general mood as measured by the Profile of Mood States (POMS) total score and subscales.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.

ARM II: Patients undergo Healthy Eating Education (HEAL) comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 2 or 3, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.

After completion of study, patients are followed up at 1 month.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed breast cancer (stage I, II, III)
* Be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (Note: use of biologics \[e.g., Herceptin (trastuzumab)\] is permitted)

  * For patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining
  * For patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining
  * Patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled
* Report sleep disturbance of 8 (sum total of all 7 items) or greater on the Insomnia Severity Index

  * (Note: this measure will be repeated again at baseline assessment)
* Report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
* Be able to speak and read English
* Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded
* Be able and willing to wear an Actiwatch for the entire 24 hours of each day they are scheduled to wear it

Exclusion Criteria:

* Have diagnosis of breast cancer stage IV
* Have sleep problems that began before diagnosis and have not changed since diagnosis
* Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
* Have a clinical diagnosis of sleep apnea or restless leg syndrome
* Be unable or unwilling to discontinue anxiolytic medication within 4 hours of intervention sessions
* Take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted
* Patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., 4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night shifts, or starting work between 4am and 7am)
* Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)

Primary outcomes:
measure: Percentage of Eligible Patients Consented
timeFrame: baseline
measure: Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT
timeFrame: Up to 1 month
measure: Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings
timeFrame: Up to 1 month
Secondary outcomes:
measure: Change in Insomnia as Measured by the Insomnia Severity Index (ISI)
timeFrame: Baseline to up to 1 month
measure: Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to up to 1 month
measure: Change in Mean Circadian Rhythm Mesor
timeFrame: Baseline to up to 1 month
measure: Change in Circadian Rhythm Amplitude Over 24 Hours
timeFrame: baseline to up to 1 month
measure: Change in Circadian Rhythm Amplitude Over 12 Hours
timeFrame: baseline to up to 1 month
measure: Change in Mean Circadian Rhythm Acrophase Over 24 Hours
timeFrame: baseline to up to 1 month
measure: Change in Mean Circadian Rhythm Acrophase Over 12 Hours
timeFrame: baseline to up to 1 month
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Decatur
country: United States
facility: Heartland NCORP
state: Illinois
city: Wichita
country: United States
facility: Wichita NCORP
state: Kansas
city: Minneapolis
country: United States
facility: Metro-Minnesota NCORP
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Program
state: North Carolina
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Oxana Palesh
role: PRINCIPAL_INVESTIGATOR
References: