Boston, Massachusetts 02114


Purpose:

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 summary:

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.


Criteria:

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.


NCT ID:

NCT02375776


Primary Contact:

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

Stephen Agboola, MD, MPH
Phone: 617-643-0291
Email: sagboola@partners.org


Backup Contact:

Email: acenti@partners.org
Amanda J Centi, PhD
Phone: 617-724-2158


Location Contact:

Boston, Massachusetts 02114
United States

Stephen Agboola, MD, MPH
Phone: 617-643-0291
Email: sagboola@partners.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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