Insomnia Interventions in Cancer Survivors

Not Applicable

• Conditions: Insomnia
• Interventions: Behavioral: MBSR; Behavioral: CBT

• Registration Number: NCT02783079
• Lead Sponsor: The Cooper Health System

Brief Summary

This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.

Detailed Description

The purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. Moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including African-Americans, Latinos and Caucasians. The results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life.

Study Timeline

• Study First Submitted: 2016-02-12
• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-25
• Last Update Submitted: 2016-05-25
• Study First Posted: 2016-05-26
• Last Update Posted: 2016-05-26
• Primary Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• signed informed consent
• age 18 and over
• diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic
• receiving treatment at one of the outpatient offices of the MD Anderson Cancer Center at Cooper
• Self reported insomnia
• Not currently taking any medications to treat insomnia
• No medical or psychological condition that would prevent successful protocol completion in the opinion of investigator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	MBSR	Mindfulness Based Stress Reduction (MBSR)
Arm 1	CBT	Cognitive Behavioral Therapy (CBT)

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index	Baseline to 6 weeks and 6 weeks to 12 weeks	Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions.

Secondary Outcome Measures

Name	Time	Method
Change in Brief Fatigue Inventory (BFI)	Baseline to 6 weeks and 6 weeks to 12 weeks	Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions.
Change in Depression, Anxiety and Stress Scale 21 (DASS21)	Baseline to 6 weeks and 6 weeks to 12 weeks	Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions
Number of patients who respond to CBT vs MBSR based on Ethnicity	12 weeks	Variations in efficacy outcomes based on ethnicity

Trial Locations

Locations (1)

MD Anderson Cancer Center at Cooper; 🇺🇸 Voorhees, New Jersey, United States