Clinical trial NCT02375776: Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Multi-modal Mobile Health Intervention
Official title: Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Multi-modal mHealth Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Cancer
Prostate Cancer
Effects of Chemotherapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: McKesson Foundation
name: Dana-Farber Cancer Institute
First posted: 2015-03-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Adherence to Oral Anti-Cancer Medications in patients with Renal Cell Cancer or Prostate Cancer on Oral Anti-Cancer Medications.
timeFrame: From randomization to end of study 12 weeks
Secondary outcomes:
measure: Severity of symptoms in patients on Oral AntiCancer Medications. (OAMs)
timeFrame: From randomization to end of study 12 weeks
measure: Hospital utilization in patients on OAMs.
timeFrame: From randomization to end of study 12 weeks
measure: Quality of life metrics in patients on OAMs.
timeFrame: From randomization to end of study 12 weeks
measure: patient engagement with the mobile-based intervention in patients on OAMs.
timeFrame: From randomization to end of study 12 weeks
measure: Severity of anxiety in patients on OAMS.
timeFrame: From randomization to end of study 12 weeks
measure: Severity of fatigue in patients on OAMs.
timeFrame: From randomization to end of study 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners HealthCare Connected Health
state: Massachusetts
Study officials:
affiliation: Center for Connected Health, Partners HealthCare
name: Kamal Jethwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: