This group will be contacted to make an appointment for outpatient Occupational and Physical therapy. The therapist will determine the type, frequency and length of treatment. Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed.

Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program. The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired.

OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.

Occupational and Physical Therapy

Mackenzi Pergolotti, PhD

The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.

This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer. Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility. Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers. Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only). Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups. We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.

The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults

Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.

As measured by the Possibilities for Activity Scale (PActS)

As measured by the Blessed Memory Orientation Concentration test

To describe the feasibility of the CARE program by reporting enrollment and retention as defined by (1) percent eligible who agree to participate (2) percent in each group that completed follow-up measures at 2 and 3 months and (3) percent of patients in CARE program who go to 70% of appointments.

Intervention Group Only: As measured by the Berg Balance Scale

Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale

Intervention Group Only: As measured by the Montreal Cognitive Assessment

Intervention Group Only: As measured by the Dynamic Gait Index

To evaluate the program a short interview will be completed with CARE team to determine what worked well, what didn't and suggested changes/improvements for CARE program after completion of project.

UNC Lineberger Comprehensive Cancer Center

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Estrogens

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Aromatase Inhibitors

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

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.

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.

OPTIMUM e-health tool

Ari N Meguerditchian, MD

Liane Feldman, MD

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.

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.

A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)

Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)

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.

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.

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.

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).

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%.

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).

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).

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).

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).

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.

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).

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.

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The CARE Program: CAncer REhabilitation Pilot Study for Older Adults	NCT02306252	Cancer	Occupational an...	65 Years -	UNC Lineberger Comprehensive Cancer Center
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)	NCT02876848	Breast Neoplasm... Medication Adhe...	OPTIMUM e-healt...	65 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for health services for the aged