Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

August 14, 2018 updated by: Hannah Arem, George Washington University
Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20052
        • GW Center for Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer
  • completed active treatment (surgery, radiation, chemotherapy) at least three months prior
  • within 5 years of treatment or still on adjuvant therapy
  • Completes informed consent to participate

Exclusion Criteria:

  • sleep apnea or restless leg syndrome
  • practicing mindfulness techniques >1/wk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT-I
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
A licensed psychologist is delivering Cognitive Behavioral Therapy for Insomnia to women for 90-120 minutes weekly for nine weeks. The Cognitive Behavioral Therapy for Insomnia protocol is well documented in published literature.
Experimental: Mindfulness
Mindfulness-Based Therapy
Behavioral: Mindfulness-Based Therapy
Participants are taught relaxation and mindfulness techniques to practice. They also learn about various alternative medicine modalities to which they can apply mindfulness with the target of reducing insomnia. The group meets weekly for 2 hours for a duration of 9 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insomnia
Time Frame: Nine weeks
Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)
Nine weeks
Change in Insomnia
Time Frame: Nine weeks
Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)
Nine weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function
Time Frame: Nine weeks
Measured via the FACT-Cog (Scale 0-132; higher is better)
Nine weeks
Change in cognitive function
Time Frame: Nine weeks
Measured via the Montreal Cognitive Assessment (MOCA)
Nine weeks
Change in Fatigue
Time Frame: Nine weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)
Nine weeks
Change in Insomnia
Time Frame: Nine weeks
Measured using an actigraph
Nine weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2017

Primary Completion (Actual)

June 28, 2018

Study Completion (Actual)

June 28, 2018

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121635

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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