Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Multi-modal Mobile Health Intervention (CORA)

August 29, 2020 updated by: Joseph C. Kvedar, Massachusetts General Hospital

Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Multi-modal mHealth Intervention

This study evaluates a smart phone based mobile application designed for patients with Renal Cell and Prostate Cancer taking oral anti-cancer medications. (OAMs) All participants will be patients at the Dana Farber Cancer Institute in Boston, Massachusetts. Half of the participants will use the mobile application for a 3 month period along with their usual care. Half of the participants will just receive usual care.

The investigators hope to show that cancer patients taking OAMs who use the mobile application will be better connected to their care team and will develop increased competency for self-care which will primarily increase medication adherence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The widespread and increasing use of oral anti-cancer medications (OAMs) has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, OAMs' popular ease of administration and potential cost savings has highlighted their central position in the healthcare system as a whole. Importantly, these facts have heightened appreciation of the unique challenges associated with OAMs use, especially in relation to prescribing, dispensing, reimbursement, education, adherence, and comprehensive quality and safety assurance. In this regard, the investigators goal is to improve medication adherence and clinical outcomes for cancer patients using OAMs through a mobile-enabled, multi-modal self-management and educational intervention .

The intervention seeks to enable patients' self-efficacy to adhere to their medications through directed education and coaching, anticipation of symptoms and associated adverse events, and closer monitoring with accurate assessment of self-reported outcomes. This innovative approach necessarily includes personalizing feedback and management based on patients' own treatment regimen, baseline knowledge and elucidated barriers to adherence, and holds great promise in improving overall adherence, safety, and clinical outcomes in these patients.

The investigators hypothesize that cancer patients on OAMs who use a mobile-based, multi-modal health self-management (M health) intervention designed for extensive patient education and symptom management will be better connected to their care team and will develop increased competency for self-care which will primarily increase medication adherence and improve secondary outcomes measured in this study compared to cancer patients on OAMs who do not use the mobile-based intervention.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Partners HealthCare Connected Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:.

  • Adult (≥18 years) patients being treated at the Dana Farber Cancer Institute for Renal Cell Cancer or Prostate Cancer commencing a new course cycle of OAMs. . - -Participants must be ambulatory and able to consent for self.
  • Participants must have an Apple or Android smart phone and be willing to download the mobile application on their smartphones so they can utilize the intervention.
  • Patients must be able to read/speak English.

Exclusion Criteria:

  • Life expectancy less than 3 months as determined by the managing oncologist.
  • Significant psychiatric co-morbidities and memory or cognitive impairments. A significant psychiatric condition includes any condition which creates major distress for a patient or which markedly impairs the patient's daily functioning. It includes, but not limited to, acute psychoses, major depressive disorder, dementia, etc
  • Patients currently on similar interventional studies geared to improve medication adherence or in investigational drug trials in which adverse effects have not been fully elucidated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Download and use mobile health application - CORA- Device:smartphones for 12 weeks.
Other: CORA- Device:smartphones"
Participants will download and use Multi - modal mobile smartphone application (CORA -Device:smarthpones) designed for renal cell and prostate cancer patients taking anti-cancer medications
No Intervention: Control
Usual Care - The control group will not use the study's mobile health application during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adherence to Oral Anti-Cancer Medications in patients with Renal Cell Cancer or Prostate Cancer on Oral Anti-Cancer Medications.
Time Frame: From randomization to end of study 12 weeks
Medication adherence will be measured throughout the course of the study by the Medication Event Monitoring System. (Continuous data regarding medication adherence will be measured through this device and recorded in real time throughout the study - a period of 3 months.)
From randomization to end of study 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of symptoms in patients on Oral AntiCancer Medications. (OAMs)
Time Frame: From randomization to end of study 12 weeks
Symptom severity will be measured using the MD Anderson Symptom Severity Inventory.
From randomization to end of study 12 weeks
Hospital utilization in patients on OAMs.
Time Frame: From randomization to end of study 12 weeks
Hospital utilization to include number of visits to Emergency Department visits, urgent clinic visits and in-patient admissions.
From randomization to end of study 12 weeks
Quality of life metrics in patients on OAMs.
Time Frame: From randomization to end of study 12 weeks
The Functional Assessment of Cancer Therapy-General (FACT-G) is an instrument used to measure health-related quality of life. been used extensively worldwide. The FACT-G has four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB).
From randomization to end of study 12 weeks
patient engagement with the mobile-based intervention in patients on OAMs.
Time Frame: From randomization to end of study 12 weeks
Data will be collected for the 12 week duration of the study from the mobile application on participants' patterns of use of application. Additionally, Closeout Survey will asses user experience using the study mobile application and will collect user feedback.
From randomization to end of study 12 weeks
Severity of anxiety in patients on OAMS.
Time Frame: From randomization to end of study 12 weeks
The Generalized Anxiety Disorder 7 Item Scale GAD-7 will be used to screen for and assess severity of generalized anxiety disorder in patients using OAMS. The GAD-7 is a self-administered 7 question instrument. It is a valid and efficient tool to screen for and asses the severity of generalized anxiety disorder. It is used in both clinical practice and research.
From randomization to end of study 12 weeks
Severity of fatigue in patients on OAMs.
Time Frame: From randomization to end of study 12 weeks
The Functional Assessment of Chronic Illness Therapy - Fatigue Version (FACIT-F) will be used to assess patient fatigue. It is a self administered 13 question instrument validated for use in chronic illness and frequently used with cancer patients.
From randomization to end of study 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute
McKesson Foundation

Investigators

  • Principal Investigator: Kamal Jethwani, MD, MPH, Center for Connected Health, Partners HealthCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 24, 2014

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-560.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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