Breast NeoplasmsNCT02876848
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
A study testing OPTIMUM e-health tool in people with Breast Neoplasms and Medication Adherence, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Medication Adherence
- What is being tested?
- OPTIMUM e-health tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Sep 2018
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Must be ≥ 65 years old,
- Have been diagnosed with incident (non-metastatic) breast cancer,
- Have a histologically-confirmed breast adenocarcinoma,
- Have undergone breast surgery for stages I-III disease,
- Have medical insurance with the Régie de l'Assurance Maladie du Québec (RAMQ) for at least 1 year prior to surgery,
- Have HR positive disease,
Show all 9Show fewer
- Have no history of AET use prior to the diagnosis of breast cancer,
- Expected to initiate AET or have only recently initiated AET (<6 months) but are free of previous discontinuation events,
- Have the ability to consent for herself.
Who cannot join
- male gender
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Ari N Meguerditchian, MD, (514) 934-1934 ext. 32999, ari.meguerditchian@mcgill.ca
About this study
Official title: Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel e-health tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians.
Read the detailed description
Objectives: 1) To determine the effectiveness of a patient-specific, real-time e-health alerts delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation. 2) To assess integration of e-health alerts regarding deviations from best practices in administration of AET by cancer care teams.
Methods: A prospective, two group controlled comparison pilot study will be conducted at two urban, McGill University-affiliated hospitals, the Royal Victoria Hospital and St. Mary's Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Healthcare professionals at the intervention site will have access to the e-health tool which will report to them in real-time: medical events with known associations to AET discontinuation, AET adherence monitor, and a discontinuation alert.
- Conditions
- Breast Neoplasms, Medication Adherence
- Being tested
- OPTIMUM e-health tool
- Keywords
- Administrative Claims, Healthcare, Aromatase Inhibitors, Breast Neoplasms, Health Services for the Aged, Medical Informatics Applications, Medication Adherence, Outcome and Process Assessment (Health Care), Selective Estrogen Receptor Modulators, Telemedicine
- Medical subject headings
- Breast Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMUM e-health toolOther
If you are treated in a hospital that is using the OPTIMUM e-health tool ("intervention" group), once your care team receives any alerts, they may choose to:
- Contact you over the phone or in person to provide medical advice on how to better take your pills,
- Contact your pharmacist(s) and other doctors about your anti-cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Site | Experimental | The hospital that will be the intervention site will have access to the OPTIMUM e-health tool. The intervention site cancer care team will receive the following OPTIMUM e-health alerts:
1. An electronic alert of increased Adjuvant Endocrine Therapy discontinuation risk.
2. An adherence to Adjuvant Endocrine Therapy monitor.
3. An electronic discontinuation occurrence alert Receives: Other: OPTIMUM e-health tool |
| Control Site | No intervention | The hospital that will be the control site will not have access to the OPTIMUM e-health tool. The cancer care team will continue to deliver care according to standard processes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients discontinuing adjuvant endocrine therapy treatment
In each trial arm, the proportion of patients discontinuing AET treatment will be calculated as the number of patients discontinuing AET treatment divided by the total number of patients in that trial arm.
Measured: 1.5 years
Secondary outcomes (13)
Primary Non-adherence
In each trial arm, the proportion of patients who are prescribed AET treatment but do not fill any prescriptions will be calculated as the number of patients with primary non-adherence divided by the total number of patients in that trial arm.
Measured: 1.5 years
Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment
In each trial arm, the proportion of patients re-initiating after a discontinuation of AET treatment will be calculated as the number of patients who start taking AET after a period of stopping divided by the total number of patients that discontinued in that trial arm.
Measured: 1.5 years
Mean time to adjuvant endocrine therapy treatment re-initiation.
In each trial arm, mean time to AET treatment re-initiation will be calculated as the average number of days for a patient who has stopped taking AET treatment to start again, among those who start again (re-initiate).
Measured: 1.5 years
Medical Possession Ratio ≥80%
In each trial arm, the proportion of patients that maintain a Medical Possession Ratio ≥80% will be calculated as the proportion patients whose proportion of number of days covered by medication supply in the treatment period is ≥80%.
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with patient
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team called the patient will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the patient was called).
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with community pharmacist
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team called the patient's pharmacist will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the patient's pharmacist was called).
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with doctor
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team arranged for the patient to return to the clinic to see the doctor will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team arranged a return to clinic with doctor).
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with nurse
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team arranged for the patient to return to the clinic to see the nurse will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team arranged a return to clinic with nurse).
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - referral to doctor for closer follow-up
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team referred the patient to a doctor will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team referred the patient to a doctor). Note that this action is different than the outcome "arrange for return to clinic with doctor" because this outcome occurs when a nurse directly schedules a patient to see a specific doctor without discussing with a doctor first.
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - referral to cancer nurse for closer follow-up
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team referred the patient to a cancer nurse will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team referred the patient to a cancer nurse).
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - ignore the alert
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment, for that patient, if no action by the cancer care team was taken will be assessed qualitatively (yes/no) and quantitatively (how many alerts per patient were ignored). Note that "ignore the alert" is an explicit option that care teams can specify. They will be trained to understand that the "ignore the alert" option represents that the patient has not discontinued AET treatment and that they are of the opinion that the patient is not at risk of discontinuing AET treatment despite reading the alert.
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - no changes in usual treatment despite new information provided
Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if no changes by the cancer care team were taken will be assessed qualitatively (yes/no) and quantitatively (how many alerts per patient were ignored). Note that this "no changes" is an explicit option that care teams can specify. They will be trained to understand that the "no changes" option represents that the patient requires other considerations beyond adhering to AET such as is stopping AET for upcoming surgery or no longer is indicated for AET based on disease progression (for e.g., brain metastases).
Measured: 1.5 years
Cancer Care Team Actions in the intervention arm - Other
Any care team action that cannot be described by the predefined actions will be described by the care team in a free-text field for subsequent qualitative analysis. An overall theme or logical grouping of these qualitative outcomes will be explored and reported upon.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Meguerditchian, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Ari N Meguerditchian, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreLiane Feldman, MD, Study director, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876848
- Sponsor's protocol ID
- MP-37-2017-2535
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
- ClinicalTrials.gov ID
- NCT02876848
- Acronym / sponsor ID
- MP-37-2017-2535
- Conditions
- Breast Neoplasms, Medication Adherence
- Keywords
- Administrative Claims, Healthcare, Aromatase Inhibitors, Breast Neoplasms, Health Services for the Aged, Medical Informatics Applications, Medication Adherence, Outcome and Process Assessment (Health Care), Selective Estrogen Receptor Modulators
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 24 Aug 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.
Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel e-health tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians.
Detailed description
Objectives: 1) To determine the effectiveness of a patient-specific, real-time e-health alerts delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation. 2) To assess integration of e-health alerts regarding deviations from best practices in administration of AET by cancer care teams.
Methods: A prospective, two group controlled comparison pilot study will be conducted at two urban, McGill University-affiliated hospitals, the Royal Victoria Hospital and St. Mary's Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Healthcare professionals at the intervention site will have access to the e-health tool which will report to them in real-time: medical events with known associations to AET discontinuation, AET adherence monitor, and a discontinuation alert.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Site | Experimental | Other: OPTIMUM e-health toolThe hospital that will be the intervention site will have access to the OPTIMUM e-health tool. The intervention site cancer care team will receive the following OPTIMUM e-health alerts: 1. An electronic alert of increased Adjuvant Endocrine Therapy discontinuation risk. 2. An adherence to Adjuvant Endocrine Therapy monitor. 3. An electronic discontinuation occurrence alert |
| Control Site | No intervention | –The hospital that will be the control site will not have access to the OPTIMUM e-health tool. The cancer care team will continue to deliver care according to standard processes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Must be ≥ 65 years old,
- Have been diagnosed with incident (non-metastatic) breast cancer,
- Have a histologically-confirmed breast adenocarcinoma,
- Have undergone breast surgery for stages I-III disease,
- Have medical insurance with the Régie de l'Assurance Maladie du Québec (RAMQ) for at least 1 year prior to surgery,
Key exclusion criteria (1 listed)
- male gender
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 |
|---|---|---|
| OPTIMUM e-health toolIf you are treated in a hospital that is using the OPTIMUM e-health tool ("intervention" group), once your care team receives any alerts, they may choose to: * Contact you over the phone or in person to provide medical advice on how to better take your pills, * Contact your pharmacist(s) and other doctors about your anti-cancer treatment. | Other | Intervention Site |
Primary outcome
Proportion of patients discontinuing adjuvant endocrine therapy treatment
Time frame: 1.5 years
In each trial arm, the proportion of patients discontinuing AET treatment will be calculated as the number of patients discontinuing AET treatment divided by the total number of patients in that trial arm.
13 secondary outcomes
Primary Non-adherence
Time frame: 1.5 years
Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment
Time frame: 1.5 years
Mean time to adjuvant endocrine therapy treatment re-initiation.
Time frame: 1.5 years
Medical Possession Ratio ≥80%
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with patient
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with community pharmacist
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with doctor
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with nurse
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - referral to doctor for closer follow-up
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - referral to cancer nurse for closer follow-up
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - ignore the alert
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - no changes in usual treatment despite new information provided
Time frame: 1.5 years
Cancer Care Team Actions in the intervention arm - Other
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
Ari N Meguerditchian, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Liane Feldman, MD study director
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMUM e-health tool in people with Breast Neoplasms and Medication Adherence, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ari N Meguerditchian, MD ((514) 934-1934 ext. 32999, ari.meguerditchian@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients discontinuing adjuvant endocrine therapy treatment (time frame: 1.5 years). 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 24 Aug 2016.