Breast CancerNCT01983995
Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients
An observational study of Breast Cancer, run by University of Michigan at 1 site in United States.
Trial summary
Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2016
- Phase
- Observational
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: University of Michigan Cancer Center
Who may be able to join
- Female, aged 50 years or older, postmenopausal.
- Patients with histologically proven stage 0-III invasive carcinoma of the breast that is estrogen receptor and/or progesterone receptor positive by immunohistochemical staining, who are planning to start treatment with a standard dose of aromatase inhibitor (AI) therapy.
- Subjects must have undergone surgical resection of their primary tumor, as indicated. The most recent surgery must have been performed at least 4 weeks before the baseline evaluation and no additional surgeries (including reconstructive procedures) should be planned during study participation.
- Cytoxic chemotherapy, if applicable, must have been completed at least 4 weeks before the baseline evaluation.
- Radiation therapy, if applicable, must have been completed at least 2 weeks before baseline evaluation.
- Eastern Cooperative Oncology Group performance status 0-2.
- Ability to operate the accelerometer
Who cannot join
- Diagnosis of sleep apnea or restless leg syndrome.
- Use of a wheelchair for ambulation most of the time.
- Second or third shift workers or other non-traditional sleep schedules.
- History of medical arthritic disease that could confound or interfere with evaluation of pain or 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.
- 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
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Prospective Pilot Study Evaluating the Inter-relationships Between Sleep Disturbance, Fatigue, Pain, and Daytime Activity in Breast Cancer Patients Starting Aromatase Inhibitor Therapy
Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In particular, we are interested in pain and difficulty sleeping. This study is designed to assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the interplay of these side effects and their subsequent impact on daily activity. Each participant will fill out a series of questionnaires about pain, sleep quality, and fatigue and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these symptoms so we can better manage medication toxicity in the future.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Aromatase Inhibitors, Actigraphy, Pain, Fatigue, Sleep quality
- Medical subject headings
- Breast Neoplasms, Pain, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Actigraphy | Postmenopausal women starting aromatase inhibitor therapy will undergo assessment with questionnaires and actigraphy before starting AI therapy and after 3 months of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting an actigraphy study with breast cancer patients
Feasibility will be measured by the proportion of breast cancer patients who are starting aromatase inhibitor therapy who complete baseline and 3 month assessment questionnaires and also enter actigraphy data correctly at least 85% of the time.
Measured: 3 months
Secondary outcomes (2)
Association between patient-reported sleep quality, fatigue, and pain and objective actigraphy measurements.
We will evaluate patterns of symptoms reported by subjects and the apparent impact of these symptoms on both daytime function and sleep quality.
Measured: 3 months
Change in pain, fatigue, sleep disturbance, and daytime activity with 3 months of aromatase inhibitor therapy
We will analyze the change in sleep, pain, fatigue, and symptom severity index between baseline and 12 weeks. We will correlate changes in symptoms from baseline to 12 weeks with actigraphy activity.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2016
- Study completionSep 2016
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 MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Responsible party
- Principal investigator, N. Lynn Henry, University of Michigan
- Investigators
- Norah L Henry, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983995
- Sponsor's protocol ID
- HUM00078882
- Other IDs
- UMCC 2013.098
- Status last verified
- Oct 2016
- First submitted
- 7 Nov 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study Evaluating the Inter-relationships Between Sleep Disturbance, Fatigue, Pain, and Daytime Activity in Breast Cancer Patients Starting Aromatase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT01983995
- Acronym / sponsor ID
- HUM00078882
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Aromatase Inhibitors, Actigraphy, Pain, Fatigue, Sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Study start
- Nov 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Nov 2013 (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.
Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In particular, we are interested in pain and difficulty sleeping. This study is designed to assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the interplay of these side effects and their subsequent impact on daily activity. Each participant will fill out a series of questionnaires about pain, sleep quality, and fatigue and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these symptoms so we can better manage medication toxicity in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actigraphy | – | –Postmenopausal women starting aromatase inhibitor therapy will undergo assessment with questionnaires and actigraphy before starting AI therapy and after 3 months of treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University of Michigan Cancer Center
Key inclusion criteria (7 listed)
- Female, aged 50 years or older, postmenopausal.
- Patients with histologically proven stage 0-III invasive carcinoma of the breast that is estrogen receptor and/or progesterone receptor positive by immunohistochemical staining, who are planning to start treatment with a standard dose of aromatase inhibitor (AI) therapy.
- Subjects must have undergone surgical resection of their primary tumor, as indicated. The most recent surgery must have been performed at least 4 weeks before the baseline evaluation and no additional surgeries (including reconstructive procedures) should be planned during study participation.
- Cytoxic chemotherapy, if applicable, must have been completed at least 4 weeks before the baseline evaluation.
- Radiation therapy, if applicable, must have been completed at least 2 weeks before baseline evaluation.
Key exclusion criteria (5 listed)
- Diagnosis of sleep apnea or restless leg syndrome.
- Use of a wheelchair for ambulation most of the time.
- Second or third shift workers or other non-traditional sleep schedules.
- History of medical arthritic disease that could confound or interfere with evaluation of pain or 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.
- Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of conducting an actigraphy study with breast cancer patients
Time frame: 3 months
Feasibility will be measured by the proportion of breast cancer patients who are starting aromatase inhibitor therapy who complete baseline and 3 month assessment questionnaires and also enter actigraphy data correctly at least 85% of the time.
2 secondary outcomes
Association between patient-reported sleep quality, fatigue, and pain and objective actigraphy measurements.
Time frame: 3 months
Change in pain, fatigue, sleep disturbance, and daytime activity with 3 months of aromatase inhibitor therapy
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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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.
Norah L Henry, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Michigan 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 25 Oct 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of conducting an actigraphy study with breast cancer patients (time frame: 3 months). 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 25 Oct 2016.