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



Status:Active, not recruiting
Conditions:Prostate Cancer, Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:March 2015
End Date:December 2018

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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.

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.

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.
We found this trial at
1
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Boston, Massachusetts 02114
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Boston, MA
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