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

NCT02375776 | Completed

• 1 other identifier: 13-560.
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Cancer; Prostate Cancer; Effects of Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Severity of symptoms in patients on Oral AntiCancer Medications. (OAMs)

  From randomization to end of study 12 weeks

• Hospital utilization in patients on OAMs.

  From randomization to end of study 12 weeks

• Quality of life metrics in patients on OAMs.

  From randomization to end of study 12 weeks

• patient engagement with the mobile-based intervention in patients on OAMs.

  From randomization to end of study 12 weeks

• Severity of anxiety in patients on OAMS.

  From randomization to end of study 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Download and use mobile health application - CORA- Device:smartphones for 12 weeks.

Other: CORA- Device:smartphones"

Control

NO INTERVENTION

Usual Care - The control group will not use the study's mobile health application during the study.

Interventions

CORA- Device:smartphones" OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• McKesson Foundation: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Partners HealthCare Connected Health

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Study Officials

• Kamal Jethwani, MD, MPH

  Center for Connected Health, Partners HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

US (1)