Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer Female; Insomnia
• Interventions: Behavioral: Mindfulness-Based Therapy; Behavioral: Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT03328169
• Lead Sponsor: George Washington University

Brief Summary

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

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 Timeline

• Study Start: 2017-04-15
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Primary Completion: 2018-06-28
• Study Completion: 2018-06-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness-Based Therapy	Mindfulness-Based Therapy
CBT-I	Cognitive Behavioral Therapy for Insomnia	Cognitive Behavioral Therapy for Insomnia

Primary Outcome Measures

Name	Time	Method
Change in Insomnia	Nine weeks	Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function	Nine weeks	Measured via the Montreal Cognitive Assessment (MOCA)
Change in Fatigue	Nine weeks	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)
Change in Insomnia	Nine weeks	Measured using an actigraph

Trial Locations

Locations (1)

GW Center for Integrative Medicine; 🇺🇸 Washington, District of Columbia, United States