Evaluating an Internet-based Intervention for Insomnia in... | NCT01141868

Studies
Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors

NCT01141868

Sponsor

Milton S. Hershey Medical Center

Status

Withdrawn

Last Update Posted

May 17, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Insomnia
Breast Cancer

Interventions

Internet Intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study never opened due to technical upgrades that were needed for the SHUTi computer system.

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jun 9, 2010

First Submission Date that Met QC Criteria

Jun 10, 2010

First Posted Date

Jun 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2013

Last Update Posted Date

May 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be assigned to either gain access to the 6-week treatment program immediately (experimental group) or following study participation (control group).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Internet Intervention	Experimental		Behavioral: Internet Intervention
Delayed Intervention	Experimental	Receive access to the online Internet intervention after completing post-assessments.	Behavioral: Internet Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Internet Intervention	Behavioral	online treatment for insomnia	Delayed Intervention Internet Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sleep efficiency	sleep-onset latency, wake after sleep onset, and number of awakenings	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
total sleep time	total hours of sleep per 24 hour period	6 wks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Female
Diagnosed with breast cancer
Age 18 and older
Completed primary treatment at least one month prior to enrollment
Diagnosis of insomnia

Exclusion criteria:

Experiencing a sleep disorder other than insomnia (e.g., sleep apnea)
Experiencing a major depressive episode or other serious psychiatric disturbance
Modification of psychotropic medications within the previous month
Undergoing current psychotherapy treatment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jane Schubart, PhD	Penn State	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072638	Patient Portals

Ancestor Terms

ID	Term
D055991	Health Records, Personal
D008499	Medical Records
D011996	Records
D003625	Data Collection

Browse Leaves

Not provided

Browse Branches

Not provided