Long Article

App-Enabled Studies Are Transforming Cancer Clinical Trials

There is now an app for almost every cancer study challenge from recruitment to retention thanks to advancements in digital health technology. And clinical trials are ripe for reinvention given their characteristically time-consuming, arduous, and expensive processes with no guarantee of a successful outcome.

But change is underway with mobile and web-based apps overcoming a variety of difficulties, such as virtual trials that eliminate traditional barriers to recruitment, enrollment, and retention because they can connect to the right participants located anywhere. Additionally, improvements are being seen in the accuracy of side effect tracking courtesy of more closely monitored data from patient-reported outcomes apps, as well as for participants who are readily documenting their quality of life updates digitally. The top scorer, however, might turn out to be gamification of patient-reported outcomes, where both participants and researchers appear to be winning at adherence, engagement, and retention that includes an element of fun.

Digital connectivity enhances participation, compliance, and accessibility for all patients

More than 1.7 million people in the United States are diagnosed with cancer for the first time each year. Despite the more than 10,000 oncology clinical trials seeking participants, less than 5 percent of cancer patients end up enrolling in trials.1,2,3

Inconvenience is a big factor for patients who choose not to enroll in clinical trials at all or end up dropping out.4 Distance to the study site from home or work and multiple visits with appointment scheduling that does not mesh with their regular routine are common barriers to both enrollment and retention.4

Given so much is at stake on both sides, researchers have been transforming their approach to clinical trials with app-based, patient-centered methods for improving enrollment and retention, as well as operational efficiencies, data accuracy, and timeliness.2,5 App-accompanied randomized controlled trials (smartRCTs) and app-based studies are expected to reduce costs, duration, and bias.5

Virtual clinical trials ease recruitment and enrollment

Location, commute times, and time-consuming study site visits are fading into the distant past as barriers to clinical trial participation.6 Big pharmaceutical companies are embracing virtual oncology clinical trials conducted through an app platform that allows for end-to-end, location-independent studies with links directly to study participants.7 By eliminating location and inconvenience, recruitment is faster, patient retention improves, and diversity is increased.7

The virtual clinical trial app is designed to allow researchers a direct connection to patients during every stage of the trial, including screening, recruitment, telemedicine care, data lock, and beyond.7 Options for where and how to collect participant data allow flexibility, which is then securely transferred via the app platform directly to researchers for immediate access.7 Additionally, patient reminders for taking study medications correctly and on time with notifications about adherence provided to researchers can be coordinated and delivered through the app.7

Patient-reported outcomes app improves accuracy

Incorporating patient-reported outcomes (PROs) into clinical data is helping track treatment side effects, such as pain, in ways that improve overall patient management and experience.8 Researchers are finding smart interventions to be feasible and accessible in cancer studies with a wider application for symptom reporting that is more patient-centered and accurate.8

In one prospective study, 101 patients with cancer who had already undergone two cycles of chemotherapy, and would be receiving at least two more, were enrolled to evaluate app-based reporting of adverse effects.8 A smartphone-based app for PROs was downloaded by each patient onto their mobile device which would lead them through the process to enter a description each time they experienced adverse effects.8

Eighty-three percent of patients found the app intervention easy to use, and more than 64 percent reported it as useful according to questionnaires completed at the end of the investigation.8 Adverse effect tracking results showed the number of negative events associated with chemotherapy increased from 0.92 to 2.26 while grading increased from 0.81 to 1.00.8 The pain rating scale rose from 0.20 to 0.99.8

Quality-of-life smart app demonstrates high acceptance

A team of researchers who developed their own health-related quality-of-life (HRQoL) assessment app wanted to evaluate the opinions of 81 oncology patients regarding mobile and app-based assistance during cancer treatment.9 For their assessment, the team used the exact worded questions from the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C3) to conduct a brief 10 query survey via iPad.9

Investigators found their app demonstrated positive outcomes related to acceptance, operability, and understandability.9 A mobile device was owned by 84 percent of patients who were a median age of 55 years old.4 Eighty-four percent of patients responded that they preferred to have a digital, mobile versus paper version of the questionnaire and took a median time of four minutes to complete the 10 questions.9 Adopting use of the app in regular day-to-day life during and after cancer treatment was acceptable to 83 percent of participants with 79 percent agreeing they would transfer their data over the internet during future interactions.9 Patients used the prototype version of the app during the evaluation where their data was stored on the individual device.9

Gamification wins adherence, engagement

Seventy-five percent of U.S. adults are reported to be non-adherent when it comes to physician-prescribed treatment regimens, which is often a risk factor for patient drop-outs in clinical trials.4 While not taking medication as prescribed is one way for patients to be non-adherent, trial participants often have additional responsibilities such as follow-up phone calls, nutritional restrictions, and journal entries to complete as well.4 Historically, researchers have relied on proactive patient education to convey the importance of completing all elements of a clinical protocol.4

Given the drop rate, a more engaging patient-centered strategy is gaining awareness and showing success. A mobile application that gamifies pain journaling is helping children with cancer report their pain patterns throughout the day by using a law-enforcement theme where patients play the role of officers.4 The compliance rate using gamification incentives was 90 percent compared to 70 percent with monetary rewards.10 Paper-based journal compliance rates have been as low as 11 percent.11

Construct validity, reliability, and feasibility were evaluated by using two descriptive studies with repeated measures.10 For construct validity and reliability assessment of the pain reports, 92 oncology patients between the ages of eight and 18 undergoing cancer treatment from four different cancer centers were enrolled.10 They were instructed to use the gamification app to self-report their level of pain two times each day over two weeks.10

App responsiveness to change in pain was evaluated with 14 patients in the second study who recorded their pain level twice a day for one week before cancer-related surgery and then again for two weeks after surgical intervention.10 Feasibility was evaluated through multiple measures in both studies.10

Correlations between average weekly pain ratings on the app, as well as the recalled least, average, and worst weekly pain ratings were moderate to high.10 Health-related, quality-of-life and pain coping correlations were low as expected.10

REFERENCES:

  1. The Future Of Clinical Trials: How AI & Big Tech Could Make Drug Development Cheaper, Faster, & More Effective. CB Insights https://www.cbinsights.com/research/clinical-trials-ai-tech-disruption/ Accessed 3/31/2019
  2. A Patient-Centered Approach in Clinical Trials: Impact on Patient Retention and Costs. Center for Healthcare Innovation https://www.chisite.org/blog/2018/3/28/a-patient-centered-approach-in-clinical-trials-impact-on-patient-retention-and-costs Accessed 3/31/2019
  3. Clinical Trials in Oncology. Centerwatch https://www.centerwatch.com/clinical-trials/listings/therapeutic-area/12/oncology/ Accessed 3/31/2019
  4. CenterWatch https://www.centerwatch.com/news-online/2016/06/27/issue-patient-retention-clinical-trials/ Accessed 3/31/2019
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  6. Novartis becomes deeper Science 37 partner, as pair aim for 10-trial launch. FierceBiotech https://www.fiercebiotech.com/biotech/novartis-becomes-deeper-science-37-partner-as-pair-aim-for-10-trial-launch Accessed 3/31/2019
  7. Science 37 https://www.science37.com/science-37-boehringer-ingelheim-initiate-collaborative-partnership-accelerate-patient-centricity-development-novel-therapies/ Accessed 3/31/2019
  8. Can a Smartphone App Track Patient Symptoms During Clinical Trials? Oncology Nurse Advisor https://www.oncologynurseadvisor.com/home/oncology-nursing/can-a-smartphone-app-track-patient-symptoms-during-clinical-trials/ Accessed 3/31/2019
  9. Mobile App Delivery of the EORTC QLQ-C30 Questionnaire to Assess Health-Related Quality of Life in Oncological Patients: Usability Study. Journal of Medical Internet Research https://mhealth.jmir.org/2018/2/e45/ Accessed 3/31/2019
  10. Pain Squad Cancer Pain Study. Body In Mind https://bodyinmind.org/pain-squad-app/ Accessed 3/31/2019
  11. Clinical Trials Need a Gamified Touch. Journal of mHealth https://thejournalofmhealth.com/clinical-trials-need-a-gamified-touch/ Accessed 3/31/2019