Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

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.

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.)