Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

Insomnia Clinical Trial

Official title:

Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328169
• Other study ID #: 121635
• Status: Completed
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: June 28, 2018

Study information

• Verified date: August 2018
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	GW Center for Integrative Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia	Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)	Nine weeks
Primary	Change in Insomnia	Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)	Nine weeks
Secondary	Change in cognitive function	Measured via the FACT-Cog (Scale 0-132; higher is better)	Nine weeks
Secondary	Change in cognitive function	Measured via the Montreal Cognitive Assessment (MOCA)	Nine weeks
Secondary	Change in Fatigue	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)	Nine weeks
Secondary	Change in Insomnia	Measured using an actigraph	Nine weeks