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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01141868
• Other study ID #: 31944EP
• Status: Withdrawn
• Phase: N/A
• First received: June 9, 2010
• Last updated: May 16, 2013
• Start date: July 2010
• Est. completion date: July 2010

Study information

• Verified date: June 2010
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Insomnia

Intervention

Behavioral:
• Internet Intervention
online treatment for insomnia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep efficiency	sleep-onset latency, wake after sleep onset, and number of awakenings	6 weeks	No
Secondary	total sleep time	total hours of sleep per 24 hour period	6 wks	No