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

Gary Morrow

Status: Completed

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Sleep Disorder; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer

Treatments: Behavioral: Telephone-Based Intervention; Behavioral: Brief Behavioral Therapy; Other: Educational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02002533

URCC12048 (Other Identifier)

UG1CA189961 (U.S. NIH Grant/Contract)

NCI-2013-01170 (Registry Identifier)

U10CA037420 (U.S. NIH Grant/Contract)

URCC-12048 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Arm I (BBT intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Based Intervention

Behavioral: Brief Behavioral Therapy

Behavioral: Telephone-Based Intervention

Arm II (control)

Active Comparator group

Description:

Patients undergo HEAL comprising nutritional education and suggestions for symptom management 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.

Treatment:

Behavioral: Telephone-Based Intervention

Other: Educational Intervention

Behavioral: Telephone-Based Intervention