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Completed

NCT Number: NCT03328169

Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Female Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GW Center for Integrative Medicine

Washington D.C., District of Columbia, 20052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Therapy

Behavioral

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.

Cognitive Behavioral Therapy for Insomnia

Behavioral

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.

Primary outcomes

  1. 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)

  2. Change in Insomnia

    Time frame: Nine weeks

    Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)

Secondary outcomes

  1. Change in cognitive function

    Time frame: Nine weeks

    Measured via the FACT-Cog (Scale 0-132; higher is better)

  2. Change in cognitive function

    Time frame: Nine weeks

    Measured via the Montreal Cognitive Assessment (MOCA)

  3. Change in Fatigue

    Time frame: Nine weeks

    Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)

  4. Change in Insomnia

    Time frame: Nine weeks

    Measured using an actigraph

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2017
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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