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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Canada

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.

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 groups in NCT02876848
Study groupRoleWhat they receive
Intervention SiteExperimentalThe 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 SiteNo interventionThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted24 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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)
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

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.

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