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

Prostate Cancer Clinical Trial

— CORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375776
• Other study ID #: 13-560.
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Effects of Chemotherapy
• Prostate Cancer
• Renal Cell Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Partners HealthCare Connected Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute, McKesson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adherence to Oral Anti-Cancer Medications in patients with Renal Cell Cancer or Prostate Cancer on Oral Anti-Cancer Medications.	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	Severity of symptoms in patients on Oral AntiCancer Medications. (OAMs)	Symptom severity will be measured using the MD Anderson Symptom Severity Inventory.	From randomization to end of study 12 weeks
Secondary	Hospital utilization in patients on OAMs.	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
Secondary	Quality of life metrics in patients on OAMs.	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
Secondary	patient engagement with the mobile-based intervention in patients on OAMs.	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
Secondary	Severity of anxiety in patients on OAMS.	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
Secondary	Severity of fatigue in patients on OAMs.	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