Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

George Washington University26 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Female Insomnia

Interventions

Mindfulness-Based TherapyBEHAVIORAL

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 InsomniaBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

GW Center for Integrative Medicine

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

Outcomes

Primary Outcomes

Change in Insomnia

Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)

Time frame: Nine weeks

Change in Insomnia

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

Time frame: Nine weeks

Secondary Outcomes

Change in cognitive function

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

Time frame: Nine weeks

Change in cognitive function

Measured via the Montreal Cognitive Assessment (MOCA)

Time frame: Nine weeks

Change in Fatigue

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

Time frame: Nine weeks

Change in Insomnia

Measured using an actigraph

Time frame: Nine weeks

Data from ClinicalTrials.gov

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