Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

NCT ID: NCT03328169

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2018-06-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Female Insomnia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT-I

Cognitive Behavioral Therapy for Insomnia

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia

Intervention Type 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.

Mindfulness

Mindfulness-Based Therapy

Group Type EXPERIMENTAL

Mindfulness-Based Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Hannah Arem

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GW Center for Integrative Medicine

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

Site Status

Countries

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United States

Other Identifiers

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121635

Identifier Type: -

Identifier Source: org_study_id

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