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NCT02157519

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

Completed NA Results posted Last updated 19 November 2018
What this trial tests

NA trial testing Mobile Application Intervention in Adherence to Medication Regime in 212 participants. Completed in 31 December 2016.

Timeline
18 February 2015
Primary endpoint
31 December 2016
31 December 2016

Quick facts

Lead sponsorMassachusetts General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment212
Start date18 February 2015
Primary completion31 December 2016
Estimated completion31 December 2016
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Adherence to Medication Regime or Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week Primary · 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

GroupValue95% CI
Mobile Application Intervention11
Standard Oncology Care20
Adherence to Oral Chemotherapy Medication Primary · 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.

GroupValue95% CI
Mobile Application Intervention81.50± 2.93
Standard Oncology Care79.16± 2.78
Change in Symptoms and Side Effects Primary · 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

Change in Symptom Severity
GroupValue95% CI
Mobile Application Intervention-0.03± 0.15
Standard Oncology Care0.08± 0.15
Change in Symptom Interference
GroupValue95% CI
Mobile Application Intervention-0.12± 0.23
Standard Oncology Care-0.11± 0.23
Change in Quality of Life Primary · 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, wh

FACT-General
GroupValue95% CI
Mobile Application Intervention0.49± 1.19
Standard Oncology Care-1.93± 1.13
FACT-Physical Well-Being
GroupValue95% CI
Mobile Application Intervention0.81± 0.48
Standard Oncology Care0.11± 0.45
FACT-Social Well-Being
GroupValue95% CI
Mobile Application Intervention-0.55± 0.53
Standard Oncology Care-2.22± 0.50
FACT-Emotional Well-Being
GroupValue95% CI
Mobile Application Intervention0.04± 0.41
Standard Oncology Care0.53± 0.40
FACT-Functional Well-Being
GroupValue95% CI
Mobile Application Intervention0.35± 0.43
Standard Oncology Care-0.40± 0.41
Treatment Satisfaction Secondary · 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), interperso

FACIT-Clinician Explanations
GroupValue95% CI
Mobile Application Intervention0.04± 0.20
Standard Oncology Care-0.34± 0.19
FACIT-Interpersonal Treatment
GroupValue95% CI
Mobile Application Intervention0.07± 0.13
Standard Oncology Care-0.29± 0.13
FACIT-Comprehensive Care
GroupValue95% CI
Mobile Application Intervention0.08± 0.52
Standard Oncology Care-0.89± 0.49
FACIT-Nursing Care
GroupValue95% CI
Mobile Application Intervention-0.45± 0.20
Standard Oncology Care-0.26± 0.19
FACIT-Trust in Clinicians
GroupValue95% CI
Mobile Application Intervention-0.24± 0.13
Standard Oncology Care-0.24± 0.12
Emergency Department Visits Secondary · 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.

GroupValue95% CI
Mobile Application Intervention0.16± 0.04
Standard Oncology Care0.14± 0.04
Hospitalizations Secondary · 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.

GroupValue95% CI
Mobile Application Intervention0.20± 0.07
Standard Oncology Care0.15± 0.07

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected during the active study period (study enrollment through post-assessment completion). As this was a behavioral intervention, adverse events were not assessed at any pre-specified time. Rather, they were recorded as reported by participants at any point during their study participation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mobile Application Intervention
Serious: 0/91 (0%)
Deaths: 3/91
Standard Oncology Care
Serious: 0/90 (0%)
Deaths: 1/90
Other adverse events (1 terms — click to expand)

ReactionSystemMobile Application Interve…Standard Oncology Care
Adherence data of one study participant was lost in the mailProduct Issues

Data from ClinicalTrials.gov NCT02157519 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life.
    Jacobs JM, Ream ME, Pensak N, Nisotel LE, et al · · 2019 · cited 94× · PMID 30865917 · DOI 10.6004/jnccn.2018.7098
  2. Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development.
    Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, et al · · 2017 · cited 66× · PMID 28428158 · DOI 10.2196/resprot.6198
  3. Fatigue in patients on oral targeted or chemotherapy for cancer and associations with anxiety, depression, and quality of life.
    Poort H, Jacobs JM, Pirl WF, Temel JS, et al · · 2020 · cited 29× · PMID 31535613 · DOI 10.1017/s147895151900066x
  4. Multilevel Interventions to Improve Medication Adherence in Older Adults: A Systematic Review and Meta-Analysis of Cognitive, Digital, Behavioral, and Socioeconomic Strategies (2015–2025)
    Mehany O, Artner A, Sebők S, Hankó B, et al · · 2026

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