Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02157519
Recruitment Status : Completed
First Posted : June 6, 2014
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph A. Greer, Ph.D., Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Adherence to Medication Regime Cancer Other: Mobile Application Intervention Not Applicable

Detailed Description:

Background: Over the last decade, novel targeted agents have revolutionized the delivery of cancer care and improved survival rates, especially in those with metastatic disease. While oral chemotherapies possess significant advantages with respect to ease of administration, patients and caregivers receive less support for adherence and monitoring of side effects. Therefore, novel interventions are essential to help patients communicate in a more open and timely manner with their oncology clinicians to support adherence. As part of Phase 1 for this Patient-Centered Outcomes Research Institute (PCORI) grant, we conducted qualitative interviews with patients, clinicians and relevant stakeholders to inform the development of the proposed mobile app intervention. For the randomized-controlled trial, the investigators will recruit and randomly assign 180 adult patients prescribed oral chemotherapy to receive either the intervention (completed smartphone mobile app) or standard care.

Objective/Hypothesis: The goals of this study are to assess the feasibility and efficacy of a mobile application to help improve adherence to oral chemotherapy and symptom to patients with cancer. We will administer the intervention at three cancer centers, hypothesizing that patients with who use the mobile app will report better adherence to their oral chemotherapy and better management of symptoms than those patients who were not assigned to the intervention.

Specific Aims: The primary aims of this study are 1) to implement a patient-centered mobile application to assess symptoms, side effects, and adherence to oral chemotherapy that is feasible for use in oncology patients, and 2) to evaluate the efficacy of the mobile application in improving patient-reported clinical outcomes.

Study Design: We will recruit and randomly assign 180 patients from the three cancer care sites who have recently been prescribed oral chemotherapy to receive either the mobile app intervention or standard care. Participants will be stratified by study site (i.e. Massachusetts General Hospital (MGH), North Shore, MGH West, and Emerson Cancer Centers), cancer type, and line of chemotherapy. This will ensure relatively equal percentages of patients from each study site, diagnosis, and line of chemotherapy will be represented in the treatment and control groups. The mobile app intervention which will consist of completing an initial chemotherapy treatment plan with their oncology clinicians, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses each week for 12 weeks. Medication adherence, symptom severity, and quality of life will serve as primary outcomes, and we will collect measures of quality cancer care as secondary targets. We will also explore whether particular patient characteristics (i.e. cancer type, demographics) affect patient response to the mobile app intervention.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer
Actual Study Start Date : February 18, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Experimental: Mobile Application Intervention
Participants 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.
Other: Mobile Application Intervention
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.

No Intervention: Standard Oncology Care
Participants in the control group will receive standard oncology care only.



Primary Outcome Measures :
  1. Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week [ Time Frame: Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment ]
    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.

  2. Adherence to Oral Chemotherapy Medication [ Time Frame: Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline) ]
    Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened.

  3. Change in Symptoms and Side Effects [ Time Frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline) ]
    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.

  4. Change in Quality of Life [ Time Frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline) ]
    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.


Secondary Outcome Measures :
  1. Treatment Satisfaction [ Time Frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline) ]
    Description: Functional Assessment of Chronic Illness Treatment-Treatment Satisfaction-Patient Satisfaction (FACIT-TS-PS), 21-items that assesses patient satisfaction with doctor and staff competence, communication, and confidence and trust in providers, as well as overall satisfaction of care (self-report). The FACIT-TS-PS uses a 0-3 numerical rating scale to assess satisfaction with healthcare, with 0 representing the lowest level of satisfaction and 3 representing the highest level of satisfaction. Four subscales are computed by taking the sum: explanations (4 items; range 0-12), interpersonal (3 items, range 0-9), comprehensive care (7 items; range 0-21), nurses (3 items; range 0-9), and trust (4 items; range 0-12). A higher score indicates greater satisfaction with care, while a lower score represents lower satisfaction with care.

  2. Emergency Department Visits [ Time Frame: Post-Assessment (12-14 weeks after baseline) ]
    Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have gone to the emergency room in the past three months on a numerical scale ranging from 0 to "5 or more". Scores ranged from 0-5. A higher score represents more frequent emergency department visits, indicating higher resource utilization.

  3. Hospitalizations [ Time Frame: Post-Assessment (12-14 weeks after baseline) ]
    Description: Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have been admitted to the hospital in the past three months on a numerical scale ranging from 0 to "5 or more". Scores ranged from 0-5. A higher score represents more frequent hospital admissions, indicating higher resource utilization.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patient Participant Inclusion Criteria

  • 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)

Clinician Participant Inclusion Criteria - Clinician participants must be oncology clinicians (i.e. physicians and nurse practitioners) who maintain at least 25% clinical practice at the Massachusetts General Hospital Cancer Center or one of its community affiliates at the North Shore or Emerson Hospital.

Stakeholder Participant Inclusion Criteria - Four groups of stakeholders will provide ongoing feedback about the study design, methods, and results. To be eligible as a stakeholder, the participant must be able to represent the interests and perspective of at least one of the following stakeholder groups:

  • Oncology Patient or Family Member
  • Oncology Clinician (e.g., Physician or Nurse Practitioner)
  • Cancer Practice Setting Administrator Health System, Community, and Society.

Exclusion Criteria:

Patient Participant Exclusion Criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157519


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital/North Shore Cancer Center
Boston, Massachusetts, United States, 01923
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital At Emerson Hospital-Bethke
Concord, Massachusetts, United States, 01742
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Joseph Greer, Ph.D Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Joseph A. Greer, Ph.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02157519     History of Changes
Other Study ID Numbers: 14-055
First Posted: June 6, 2014    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: April 2018

Keywords provided by Joseph A. Greer, Ph.D., Massachusetts General Hospital:
Oral Chemotherapy
Cancer