InsomniaNCT01141868
Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
A study testing Internet Intervention in people with Insomnia and Breast Cancer, run by Milton S. Hershey Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia, Breast Cancer
- What is being tested?
- Internet Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Diagnosed with breast cancer
- Age 18 and older
- Completed primary treatment at least one month prior to enrollment
- Diagnosis of insomnia
Who cannot join
- 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
About this study
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).
- Conditions
- Insomnia, Breast Cancer
- Being tested
- Internet Intervention
- Keywords
- insomnia, breast cancer survivor, Internet intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet InterventionBehavioural
Also called Internet
online treatment for insomnia
| Study group | Role | What they receive |
|---|---|---|
| Internet Intervention | Experimental | Not described Receives: Behavioral: Internet Intervention |
| Delayed Intervention | Experimental | Receive access to the online Internet intervention after completing post-assessments. Receives: Behavioral: Internet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep efficiency
sleep-onset latency, wake after sleep onset, and number of awakenings
Measured: 6 weeks
Secondary outcomes (1)
total sleep time
total hours of sleep per 24 hour period
Measured: 6 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: The study never opened due to technical upgrades that were needed for the SHUTi computer system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jane Schubart, PhD, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141868
- Sponsor's protocol ID
- 31944EP
- Status last verified
- Jun 2010
- First submitted
- 9 Jun 2010
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01141868
- Acronym / sponsor ID
- 31944EP
- Conditions
- Insomnia, Breast Cancer
- Keywords
- insomnia, breast cancer survivor, Internet intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never opened due to technical upgrades that were needed for the SHUTi computer system.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Intervention | Experimental | Behavioral: Internet Intervention |
| Delayed Intervention | Experimental | Behavioral: Internet InterventionReceive access to the online Internet intervention after completing post-assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Diagnosed with breast cancer
- Age 18 and older
- Completed primary treatment at least one month prior to enrollment
- Diagnosis of insomnia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet InterventionAlso: Internetonline treatment for insomnia | Behavioural | Delayed Intervention, Internet Intervention |
Primary outcome
sleep efficiency
Time frame: 6 weeks
sleep-onset latency, wake after sleep onset, and number of awakenings
1 secondary outcome
total sleep time
Time frame: 6 wks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Schubart, PhD principal investigator
Penn State
Questions about this trial
What is this clinical trial studying?
A study testing Internet Intervention in people with Insomnia and Breast Cancer, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep efficiency (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.