NCT02783079

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

February 12, 2016

Last Update Submit

May 25, 2016

Conditions

Insomnia

Keywords

Breast CancerProstate CancerColon CancerLung CancerGynecologic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in Brief Fatigue Inventory (BFI)

    Baseline to 6 weeks and 6 weeks to 12 weeks

  • Change in Depression, Anxiety and Stress Scale 21 (DASS21)

    Baseline to 6 weeks and 6 weeks to 12 weeks

  • Number of patients who respond to CBT vs MBSR based on Ethnicity

    12 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT)

Behavioral: CBT

Arm 2

ACTIVE COMPARATOR

Mindfulness Based Stress Reduction (MBSR)

Behavioral: MBSR

Interventions

CBTBEHAVIORAL
Also known as: cognitive behavioral therapy
Arm 1
MBSRBEHAVIORAL
Also known as: mindfulness based stress reduction
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States

Location

MD Anderson Cancer Center at Cooper

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersBreast NeoplasmsProstatic NeoplasmsColonic NeoplasmsLung Neoplasms

Interventions

Cognitive Behavioral TherapyMindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMindfulness

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

May 26, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

US(2)