Breast CancerCEASENCT01351844
The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
A study testing Education and exercise intervention and Education and General Exercise in people with Breast Cancer and Arthralgia, run by George Washington University at 1 site in United States.
Trial summary
Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Arthralgia
- What is being tested?
- Education and exercise intervention and Education and General Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2013
- 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
- Post-menopausal stage I-III breast cancer patients
- Starting or about to start aromatase inhibitor
- English speaking with ability to read, write and use a computer to watch and listen to an educational module.
- Able to give informed consent
Who cannot join
- Aromatase inhibitor (AI) use for more than 6 months
- Metastatic breast cancer
- Non-English speaking, or unable to read, write or use a computer to watch and listen to an educational module.
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Victoria Shanmugam
Washington D.C., District of Columbia, 20037
About this study
Official title: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. The purpose of this study is to see whether a computer-based educational module is a feasible intervention to help address these symptoms. If the patients agree to participate, a research coordinator will test their grip strength and give them a computer log-on code. They will be shown how to log-on to complete the educational module and a few simple questionnaires. Patients have the option to do this from home if they wish. In 3 months time, the investigators will ask patients to return to the clinic and have another grip strength evaluation and complete some additional questionnaires. The computer module and the follow up visit will each take about 30 minutes of time.
- Conditions
- Breast Cancer, Arthralgia
- Being tested
- Education and exercise intervention, Education and General Exercise
- Keywords
- Aromatase inhibitor, Arthralgia Syndrome, Exercise
- Medical subject headings
- Breast Neoplasms, Arthralgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and exercise interventionBehavioural
An occupational therapist who has clinical experience in hand therapy for breast cancer patients with arthralgia syndrome, will review 4-5 exercises which improve hand range of motion and reduce hand stiffness.
Education and General ExerciseBehavioural
A physical therapist with experience in treating breast cancer patients with lymphedema will demonstrate a series of 4-5 general stretching and toning exercises.
| Study group | Role | What they receive |
|---|---|---|
| Education and exercise intervention | Active comparator | The "intervention" module will contain a brief series of slides with a voice-over. An occupational therapist will review recommended exercises. Receives: Behavioral: Education and exercise intervention |
| Education and general exercise | Placebo comparator | The "control" module will contain a brief series of slides with a voice-over. A physical therapist with experience in treating breast cancer patients will demonstrate a series of 4-5 general stretching and toning exercises. Receives: Behavioral: Education and General Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
This study is designed as a pilot study to assess feasibility of this educational intervention in a small population of only 40 patients. Patients will be given the option to complete the module from home. The primary endpoint will be patient completion of the educational module and follow-up questionnaires.
Measured: 3 months
Secondary outcomes (1)
Grip Strength
The impact of the exercise education on symptoms will be assessed using grip strength evaluation with dynamometer at the baseline and three month follow-up visits, along with standardized pain and quality of life questionnaires completed at both time points.
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 posted11 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Unable to recruit sufficient patients
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Shanmugam, George Washington University
- Investigators
- Victoria K Shanmugam, MD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351844
- Sponsor's protocol ID
- 2010-548
- Acronym
- CEASE
- Status last verified
- Aug 2017
- First submitted
- 10 May 2011
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT01351844
- Acronym / sponsor ID
- CEASE / 2010-548
- Conditions
- Breast Cancer, Arthralgia
- Keywords
- Aromatase inhibitor, Arthralgia Syndrome, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient patients
- Enrolment
- 12 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 May 2011 (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.
Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. The purpose of this study is to see whether a computer-based educational module is a feasible intervention to help address these symptoms. If the patients agree to participate, a research coordinator will test their grip strength and give them a computer log-on code. They will be shown how to log-on to complete the educational module and a few simple questionnaires. Patients have the option to do this from home if they wish. In 3 months time, the investigators will ask patients to return to the clinic and have another grip strength evaluation and complete some additional questionnaires. The computer module and the follow up visit will each take about 30 minutes of time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and exercise intervention | Active comparator | Behavioral: Education and exercise interventionThe "intervention" module will contain a brief series of slides with a voice-over. An occupational therapist will review recommended exercises. |
| Education and general exercise | Placebo comparator | Behavioral: Education and General ExerciseThe "control" module will contain a brief series of slides with a voice-over. A physical therapist with experience in treating breast cancer patients will demonstrate a series of 4-5 general stretching and toning exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-menopausal stage I-III breast cancer patients
- Starting or about to start aromatase inhibitor
- English speaking with ability to read, write and use a computer to watch and listen to an educational module.
- Able to give informed consent
Key exclusion criteria (4 listed)
- Aromatase inhibitor (AI) use for more than 6 months
- Metastatic breast cancer
- Non-English speaking, or unable to read, write or use a computer to watch and listen to an educational module.
- Unable to give informed consent
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 |
|---|---|---|
| Education and exercise interventionAn occupational therapist who has clinical experience in hand therapy for breast cancer patients with arthralgia syndrome, will review 4-5 exercises which improve hand range of motion and reduce hand stiffness. | Behavioural | Education and exercise intervention |
| Education and General ExerciseA physical therapist with experience in treating breast cancer patients with lymphedema will demonstrate a series of 4-5 general stretching and toning exercises. | Behavioural | Education and general exercise |
Primary outcome
Feasibility
Time frame: 3 months
This study is designed as a pilot study to assess feasibility of this educational intervention in a small population of only 40 patients. Patients will be given the option to complete the module from home. The primary endpoint will be patient completion of the educational module and follow-up questionnaires.
1 secondary outcome
Grip Strength
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
Victoria K Shanmugam, MD principal investigator
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and exercise intervention and Education and General Exercise in people with Breast Cancer and Arthralgia, run by George Washington University 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 4 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: stopped early, as of the sponsor's last update on 30 Aug 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. Some participants in this study may receive a placebo. 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: Unable to recruit sufficient patients). 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?
Feasibility (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 30 Aug 2017.