Breast CancerNCT02712437
Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer
A study testing PROSPECT in people with Breast Cancer and Insomnia, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Women with early stage breast cancer may experience difficulty falling asleep or staying asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Insomnia
- What is being tested?
- PROSPECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2016to 9 Mar 2017
- 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
- Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score >14
- Insomnia present for > 30 days per patient report
- Female gender
- Histologically proven stage 0-III invasive carcinoma of the breast
- Patient's must have completed primary surgical resection at least 2 weeks prior to enrollment, radiation at least 2 weeks prior to enrollment and/or cytotoxic chemotherapy at least 6 weeks prior to enrollment in the study
- ECOG performance status 0-2
- Ability to operate the accelerometer (Actiwatch Spectrum Pro)
- The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent document
Who cannot join
- Subjects who do not have access to the internet to use the internet-based module, PROSPECT
- Initiation of hormone therapy <4 weeks prior to enrollment in the study
- Initiation of sleep aids, including over-the-counter or prescription medications taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for < 4 weeks prior to enrollment in the study
- Use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy
- History of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (Rheumatoid Arthritis, Systemic Lupus Spondyloarthropathy, Psoriatic Arthritis, Polymyalgia Rheumatica), Parkinson's disease and cancer involving the bone
- Second or third shift workers or others with non-traditional sleep schedules
- Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Unvisterity of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Prospective Study Evaluating the Use of PROSPECT, a Cognitive Behavioral Therapy-based Internet Module, to Reduce Insomnia in Patients With Early Stage Breast Cancer
Women with early stage breast cancer may experience difficulty falling asleep or staying asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia. Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of medications for sleep and an overall decrease in quality of life.
The investigators have developed an internet-based website that is designed to help people manage symptoms typically experienced by breast cancer survivors, including insomnia, fatigue, pain and overall poor quality of life. The investigators want to learn whether this type of treatment can reduce chronic insomnia and improve the way subjects feel using both questionnaires and a special form of a wrist watch. This information may help the investigators better manage sleep difficulties in subjects who experience these symptoms after diagnosis of their breast cancer.
- Conditions
- Breast Cancer, Insomnia
- Being tested
- PROSPECT
- Keywords
- Insomnia, Quality of Life, Cognitive behavioral therapy
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSPECTBehavioural
PROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms, including insomnia, through non-pharmacologic approaches.
| Study group | Role | What they receive |
|---|---|---|
| PROSPECT | Experimental | Participants who have received treatment for early stage breast cancer and who experience chronic insomnia as assessed by difficulty sleeping for >30 days with an insomnia severity index score of >14. Participants will complete baseline symptom questionnaires and actigraphy, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 6 weeks. Participants will then repeat questionnaires and actigraphy at 6 weeks and questionnaires at 12 weeks. Receives: Behavioral: PROSPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index
Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index
Measured: 6 weeks
Secondary outcomes (1)
Change in Sleep Disturbance as measured by Actigraphy
Sleep disturbance will be measured through the use of actigraphy watches to be worn for 7 days at baseline and 7 days after 6 weeks of the intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start16 Mar 2016
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
Why it stopped: The study was terminated because of low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel F Hayes, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712437
- Sponsor's protocol ID
- UMCC 2015.168
- Status last verified
- Sep 2017
- First submitted
- 15 Mar 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Use of PROSPECT, a Cognitive Behavioral Therapy-based Internet Module, to Reduce Insomnia in Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02712437
- Acronym / sponsor ID
- UMCC 2015.168
- Conditions
- Breast Cancer, Insomnia
- Keywords
- Insomnia, Quality of Life, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of low accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 18 Mar 2016 (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.
Women with early stage breast cancer may experience difficulty falling asleep or staying asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia. Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of medications for sleep and an overall decrease in quality of life.
The investigators have developed an internet-based website that is designed to help people manage symptoms typically experienced by breast cancer survivors, including insomnia, fatigue, pain and overall poor quality of life. The investigators want to learn whether this type of treatment can reduce chronic insomnia and improve the way subjects feel using both questionnaires and a special form of a wrist watch. This information may help the investigators better manage sleep difficulties in subjects who experience these symptoms after diagnosis of their breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROSPECT | Experimental | Behavioral: PROSPECTParticipants who have received treatment for early stage breast cancer and who experience chronic insomnia as assessed by difficulty sleeping for >30 days with an insomnia severity index score of >14. Participants will complete baseline symptom questionnaires and actigraphy, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 6 weeks. Participants will then repeat questionnaires and actigraphy at 6 weeks and questionnaires at 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score >14
- Insomnia present for > 30 days per patient report
- Female gender
- Histologically proven stage 0-III invasive carcinoma of the breast
- ECOG performance status 0-2
Key exclusion criteria (7 listed)
- Subjects who do not have access to the internet to use the internet-based module, PROSPECT
- Initiation of hormone therapy <4 weeks prior to enrollment in the study
- Initiation of sleep aids, including over-the-counter or prescription medications taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for < 4 weeks prior to enrollment in the study
- Use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy
- History of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (Rheumatoid Arthritis, Systemic Lupus Spondyloarthropathy, Psoriatic Arthritis, Polymyalgia Rheumatica), Parkinson's disease and cancer involving the bone
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 |
|---|---|---|
| PROSPECTPROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms, including insomnia, through non-pharmacologic approaches. | Behavioural | PROSPECT |
Primary outcome
Change in Insomnia Severity Index
Time frame: 6 weeks
Insomnia will be measured through the use of a validated survey called the Insomnia Severity Index
1 secondary outcome
Change in Sleep Disturbance as measured by Actigraphy
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: The study was terminated because of low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Daniel F Hayes, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROSPECT in people with Breast Cancer and Insomnia, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: The study was terminated because of low accrual.). Results are not available in the source record.
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?
Change in Insomnia Severity Index (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 8 Sep 2017.