## Protocol Section
### Identification Module
**NCT ID:** NCT02783079

**Brief Title:** Insomnia Interventions in Cancer Survivors

**Official Title:** Insomnia Interventions in Cancer Survivors

#### Organization Study ID Info
**ID:** 15-146EX
#### Organization
**Class:** OTHER
**Full Name:** The Cooper Health System
### Status Module
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2016-05-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-25

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-05

**Status Verified Date:** 2016-05

#### Study First Post Date
**Date:** 2016-05-26
**Type:** ESTIMATED
**Study First Submit Date:** 2016-02-12
**Study First Submit QC Date:** 2016-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Cooper Health System

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Insomnia

**Keywords:**

- Breast Cancer

- Prostate Cancer

- Colon Cancer

- Lung Cancer

- Gynecologic Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 210

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cognitive Behavioral Therapy (CBT)

**Intervention Names:**

- Behavioral: CBT

**Label:** Arm 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Mindfulness Based Stress Reduction (MBSR)

**Intervention Names:**

- Behavioral: MBSR

**Label:** Arm 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1

**Name:** CBT

**Other Names:**

- cognitive behavioral therapy

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Arm 2

**Name:** MBSR

**Other Names:**

- mindfulness based stress reduction

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions.

**Measure:** Change in Insomnia Severity Index

**Time Frame:** Baseline to 6 weeks and 6 weeks to 12 weeks

#### Secondary Outcomes

**Description:** Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions.

**Measure:** Change in Brief Fatigue Inventory (BFI)

**Time Frame:** Baseline to 6 weeks and 6 weeks to 12 weeks

**Description:** Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions

**Measure:** Change in Depression, Anxiety and Stress Scale 21 (DASS21)

**Time Frame:** Baseline to 6 weeks and 6 weeks to 12 weeks

**Description:** Variations in efficacy outcomes based on ethnicity

**Measure:** Number of patients who respond to CBT vs MBSR based on Ethnicity

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Camden

**Contacts:**

***Contact 1:***

- **Phone:** 856-735-6100

- **Role:** CONTACT

**Country:** United States

**Facility:** MD Anderson Cancer Center at Cooper

**State:** New Jersey

**Zip:** 08103

**Location 2:**

**City:** Voorhees

**Contacts:**

***Contact 1:***

- **Phone:** 856-325-6750

- **Role:** CONTACT

**Country:** United States

**Facility:** MD Anderson Cancer Center at Cooper

**State:** New Jersey

**Zip:** 08043

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10356

- Name: Sleep Initiation and Maintenance Disorders

- Relevance: HIGH

- As Found: Insomnia

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007319

- Term: Sleep Initiation and Maintenance Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
