Insomnia Interventions in Cancer Survivors

Insomnia Clinical Trial

Official title:

Insomnia Interventions in Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02783079
• Other study ID #: 15-146EX
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2016
• Last updated: May 25, 2016
• Start date: May 2016

Study information

• Verified date: May 2016
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• CBT

• MBSR

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center at Cooper	Camden	New Jersey
United States	MD Anderson Cancer Center at Cooper	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index	Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions.	Baseline to 6 weeks and 6 weeks to 12 weeks	No
Secondary	Change in Brief Fatigue Inventory (BFI)	Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions.	Baseline to 6 weeks and 6 weeks to 12 weeks	No
Secondary	Change in Depression, Anxiety and Stress Scale 21 (DASS21)	Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions	Baseline to 6 weeks and 6 weeks to 12 weeks	No
Secondary	Number of patients who respond to CBT vs MBSR based on Ethnicity	Variations in efficacy outcomes based on ethnicity	12 weeks	No