Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer
1 other identifier
interventional
212
1 country
3
Brief Summary
Many people treated for cancer receive oral chemotherapy medications for their illness. This means that much of their cancer care occurs at home, away from a traditional oncology care setting. The purpose of this study is to explore how a Smartphone mobile application ("mobile app") can help improve the cancer treatment process in people who are prescribed oral chemotherapy medication. The investigators will explore how well the mobile app helps patients stay connected with their oncology care team, take their oral medications as prescribed, and manage their cancer-related symptoms from home. This study will be done in two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention, and 2) a randomized-controlled trial to test the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedStudy Start
First participant enrolled
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedResults Posted
Study results publicly available
November 19, 2018
CompletedNovember 19, 2018
April 1, 2018
1.9 years
June 4, 2014
March 31, 2017
April 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week
The Morisky Medication Adherence Questionnaire (MMAS-4) - a 4-item questionnaire that assesses medication adherence in the past week by asking patients to indicate "yes" or "no" to each item (self-report). The four items ask patients to self-report whether they forgot to take their oral chemotherapy (OC) medication in the past week, whether they had any problems remembering to take their OC medication in the last week, whether they stopped taking their OC medication when they felt better in the past week, and whether they stopped taking their OC medication when they felt worse in the past week. Participants who answered "yes" to any of the four items were coded as having adherence problems, while those who indicated "no" to all four items were coded as having no adherence problems. Therefore, the count of participants is the number of participants who reported any difficulties with adherence on any of the four items in the past week.
Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment
Adherence to Oral Chemotherapy Medication
Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened.
Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline)
Change in Symptoms and Side Effects
M.D. Anderson Symptom Inventory (MDASI): a 19-item instrument that assesses the most common symptoms and side effects related to cancer and its treatment (self-report). The MDASI uses a 0-10 numerical rating scale for all items to assess the severity and interference of symptoms patients have experienced in the past 24 hours, with 0 being "not present" or "did not interfere" and 10 being "as bad as you can imagine" or "interfered completely". The ratings in the MDASI are averaged into two subscale scores: mean symptom severity (13 symptom items) and mean interference (6 interference items only), with possible scores on both subscales ranging from 0-10. Higher scores indicate worse symptom severity and interference, while lower scores indicate less symptom severity and interference.
Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Change in Quality of Life
Functional Assessment of Cancer Treatment - General (FACT-G): a 27-item questionnaire that assesses physical, social, emotional, and functional well-being (self-report). The FACT-G utilizes a five-point scale from 0 (not at all) to 4 (very much). Four subscales are computed by taking the sum: physical well-being (7 items; range 0-28), social/family well-being (7 items; range 0-28), emotional well-being (7 items; range 0-24), and functional well-being (7 items; range 0-28). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate greater quality of life, while lower scores indicate a worse quality of life.
Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Secondary Outcomes (3)
Treatment Satisfaction
Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Emergency Department Visits
Post-Assessment (12-14 weeks after baseline)
Hospitalizations
Post-Assessment (12-14 weeks after baseline)
Study Arms (2)
Mobile Application Intervention
EXPERIMENTALParticipants in the intervention group will receive the mobile application for improving symptoms and adherence to oral chemotherapy along with their standard oncology care. The proposed elements of the mobile application include the following: 1) specification of an oral chemotherapy treatment plan; 2) weekly collection of patient-reported symptoms and medication adherence; and 3) delivery of real-time, tailored feedback to patients as well as immediate transmission of survey results to oncology clinicians.
Standard Oncology Care
NO INTERVENTIONParticipants in the control group will receive standard oncology care only.
Interventions
Participants assigned to the intervention group will receive the mobile application intervention for approximately three months after enrollment. The mobile app intervention will consist of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app will also be transmitted in real-time to the participants' oncology clinicians via a HIPAA-compliant, secure email.
Eligibility Criteria
You may qualify if:
- Age greater than 18 years
- Diagnosis of cancer with a new or existing prescription for oral chemotherapy
- Receiving cancer care at either Massachusetts General Hospital Cancer Center or community affiliates (North Shore or Emerson Hospitals)
- Eastern Cooperative Oncology Group (ECOG) ranging from 0 (asymptomatic) to 2 (symptomatic and in bed \>50% of the day)
- Able to read and respond to questions in English
- Uses smart mobile phone (either operating system (iOS) \[iPhone\] or Android device)
- Oncology Patient or Family Member
- Oncology Clinician (e.g., Physician or Nurse Practitioner)
- Cancer Practice Setting Administrator Health System, Community, and Society.
You may not qualify if:
- Individuals with co-morbid acute or untreated psychiatric symptoms (e.g., psychosis) or neurologic dysfunction will be excluded given that such symptoms would interfere with consent and participation.
- Individuals who own Windows or Blackberry smart mobile phones will not be eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Massachusetts General Hospital/North Shore Cancer Center
Boston, Massachusetts, 01923, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital At Emerson Hospital-Bethke
Concord, Massachusetts, 01742, United States
Related Publications (1)
Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, Jacobs JM, Flanagan C, Jethwani K, Greer JA. Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development. JMIR Res Protoc. 2017 Apr 20;6(4):e62. doi: 10.2196/resprot.6198.
PMID: 28428158DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to a clerical error, the M.D. Anderson Symptom Inventory (MDASI) was not administered to 31 participants at baseline, which led to fewer cases available for analysis of change in this outcome.
Results Point of Contact
- Title
- Joseph Greer, PhD
- Organization
- Massachusetts General Hospital Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Greer, Ph.D
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2014
First Posted
June 6, 2014
Study Start
February 18, 2015
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
November 19, 2018
Results First Posted
November 19, 2018
Record last verified: 2018-04