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WithdrawnNCT01141868Updated May 17, 2013

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

An interventional study of Internet Intervention in Insomnia and Breast Cancer, sponsored by Milton S. Hershey Medical Center. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-17.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
The study never opened due to technical upgrades that were needed for the SHUTi computer system.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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).

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Conditions studied

  • Insomnia
  • Breast Cancer

Keywords

  • insomnia
  • breast cancer survivor
  • Internet intervention
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Internet Intervention

    Behavioral: Internet Intervention

  • Experimental
    Delayed Intervention

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

    Behavioral: Internet Intervention

Interventions

  • BehavioralInternet Intervention

    online treatment for insomnia

    Also known as: Internet

06

What researchers measure

Primary outcomes

  1. sleep efficiency

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

    Time frame: 6 weeks

Secondary outcomes

  1. total sleep time

    total hours of sleep per 24 hour period

    Time frame: 6 wks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01141868
Lead sponsor
Milton S. Hershey Medical Center
First posted
Jun 11, 2010
Start date
Jul 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
May 17, 2013

Study contacts

Jane Schubart, PhD
principal investigator · Penn State

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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