NCT02165839

Brief Summary

PRIMARY OBJECTIVE(S): To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy. SECONDARY OBJECTIVE(S):

  • To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.
  • To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

4.5 years

First QC Date

June 11, 2014

Results QC Date

July 17, 2020

Last Update Submit

December 1, 2020

Conditions

Breast CancerInsomnia

Outcome Measures

Primary Outcomes (1)

  • Insomnia Severity Index (ISI)

    The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: * 0 to 7 = No clinically significant insomnia * 8 to14 = Sub-threshold insomnia (mild) * 15 to 21 = Clinical insomnia (moderate severity) * 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.

    12 months

Secondary Outcomes (7)

  • Brief Fatigue Inventory (BFI)

    12 months

  • Clinical Assessment of Depression (CAD)

    12 months

  • Comprehensive Trail Making Test (CTMT)

    At baseline, post intervention, 6 months and 12 months

  • Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall

    At baseline, post intervention, 6 months and 12 months

  • Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory

    At baseline, post intervention, 6 months and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Healthy Eating Education Learning (HEAL)

ACTIVE COMPARATOR

Control group.

Behavioral: Healthy Eating Education Learning (HEAL)

Brief Behavioral Therapy for Insomnia (BBT-I)

EXPERIMENTAL
Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)

Interventions

Brief Behavioral Therapy for Insomnia (BBT-I)BEHAVIORAL
Brief Behavioral Therapy for Insomnia (BBT-I)
Healthy Eating Education Learning (HEAL)BEHAVIORAL
Healthy Eating Education Learning (HEAL)

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadult females ≥ 21 years of age
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Diagnosis of Breast Cancer (Stage I-IIIA)
  • Scheduled for planned cancer treatment (eg, chemotherapy or biologic agents), or treatment is continuing
  • Has ≥ 6 weeks of cancer treatment (eg, chemotherapy or biologic agents) remaining
  • ≥ 21 years of age.
  • Able to understand written and spoken English.
  • Sleep disturbance of 8 or greater on the ISI, and insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy (to exclude pre-existing, chronic insomnia).
  • Karnofsky score ≥ 70

You may not qualify if:

  • Have an unstable self-reported medical or psychiatric illness (Axis I - current or within the last 5 years).
  • Be currently pregnant or nursing
  • History of substance abuse or meet criteria for current alcohol abuse or dependence
  • History (self-reported) of sleep apnea or restless leg syndrome (RLS)
  • 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
  • Unable or unwilling to discontinue anxiolytics within 4 hours of education sessions
  • Irregular heartbeat or arrhythmia (self-reported or in the medical record)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94305, United States

Location

Related Publications (2)

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PMID: 41170811DERIVED

  • Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.

    PMID: 34357593DERIVED

MeSH Terms

Conditions

Breast NeoplasmsSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Oxana Palesh, Associate Professor of Psychiatry and Behavioral Sciences
Organization
Stanford University
oxana.palesh@stanford.edu
(650) 725-7011

Study Officials

  • Oxana Palesh, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oxana Palesh PhD, MPH

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 18, 2014

Study Start

January 1, 2015

Primary Completion

June 19, 2019

Study Completion

June 1, 2020

Last Updated

December 3, 2020

Results First Posted

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)