NCT01141868

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).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Status
withdrawn

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

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 17, 2013

Status Verified

June 1, 2010

Enrollment Period

Same day

First QC Date

June 9, 2010

Last Update Submit

May 16, 2013

Conditions

InsomniaBreast Cancer

Keywords

insomniabreast cancer survivorInternet intervention

Outcome Measures

Primary Outcomes (1)

  • sleep efficiency

    sleep-onset latency, wake after sleep onset, and number of awakenings

    6 weeks

Secondary Outcomes (1)

  • total sleep time

    6 wks

Study Arms (2)

Internet Intervention

EXPERIMENTAL
Behavioral: Internet Intervention

Delayed Intervention

EXPERIMENTAL

Receive access to the online Internet intervention after completing post-assessments.

Behavioral: Internet Intervention

Interventions

Internet InterventionBEHAVIORAL

online treatment for insomnia

Also known as: Internet
Delayed InterventionInternet Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersBreast Neoplasms

Interventions

Patient Portals

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Records, PersonalMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Jane Schubart, PhD

    Penn State

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 11, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 17, 2013

Record last verified: 2010-06