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

NCT ID: NCT02002533

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-03
• Study Completion Date: 2016-12-16

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (BBT intervention)

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.

Group Type: EXPERIMENTAL

Brief Behavioral Therapy

Intervention Type: BEHAVIORAL

Undergo BBT intervention

Telephone-Based Intervention

Intervention Type: BEHAVIORAL

Undergo BBT intervention

Arm II (control)

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.

Group Type: ACTIVE_COMPARATOR

Educational Intervention

Intervention Type: OTHER

Undergo HEAL

Telephone-Based Intervention

Intervention Type: BEHAVIORAL

Undergo HEAL

Interventions

Brief Behavioral Therapy

Undergo BBT intervention

Intervention Type: BEHAVIORAL

Telephone-Based Intervention

Undergo BBT intervention

Intervention Type: BEHAVIORAL

Educational Intervention

Undergo HEAL

Intervention Type: OTHER

Telephone-Based Intervention

Undergo HEAL

Intervention Type: BEHAVIORAL

Other Intervention Names

Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Education for Intervention; Intervention, Educational

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.)

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Gary Morrow

OTHER

Sponsor Role: lead

Responsible Party

Gary Morrow

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oxana Palesh

Role: PRINCIPAL_INVESTIGATOR

University of Rochester NCORP Research Base

Locations

Stanford University Medical Center

Stanford, California, United States

Heartland NCORP

Decatur, Illinois, United States

Wichita NCORP

Wichita, Kansas, United States

Metro-Minnesota NCORP

Minneapolis, Minnesota, United States

University of Rochester

Rochester, New York, United States

Southeast Clinical Oncology Research Program

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2013-01170

Identifier Type: REGISTRY

Identifier Source: secondary_id

URCC12048

Identifier Type: OTHER

Identifier Source: secondary_id

URCC-12048

Identifier Type: OTHER

Identifier Source: secondary_id

URCC12048

Identifier Type: OTHER

Identifier Source: secondary_id

UG1CA189961

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA037420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

URCC12048

Identifier Type: -

Identifier Source: org_study_id