Results Summary
What was the research about?
Patients with cancer must often take chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. Many patients prefer taking the medicines at home and by mouth, called oral chemotherapy, rather than getting infusions at a medical center. Patients taking oral chemotherapy must remember to take the medicines on time. They must also deal with side effects or symptoms at home.
The research team wanted to learn if a smartphone app could help patients follow oral chemotherapy treatment plans at home. The smartphone app included reminders of when to take the medicines. It also provided information on cancer care and coping with side effects. Patients could use the app to send weekly reports of their side effects or symptoms to their doctors.
What were the results?
The research team found no differences between patients who did and didn’t use the smartphone app in
- Taking oral chemotherapy as planned
- Having symptoms or side effects from the chemotherapy
- Improving their quality of life
Who was in the study?
The study included 181 adult patients receiving oral chemotherapy. The patients received care from a hospital in Boston, Massachusetts. All the patients owned a smartphone.
Of these patients, 54 percent were women, 88 percent were white, and 12 percent were other races. The average age was 53. Patients had different types of cancer, including cancers of the blood (33 percent), lung (18 percent), breast (14 percent), and brain (11 percent).
What did the research team do?
To develop and test the smartphone app, the research team worked with patients, cancer doctors, and health system workers. Then, the team assigned patients to one of two groups by chance. Patients in the first group received chemotherapy and used the app. Patients in the second group received chemotherapy but didn’t use the app. All patients used medicine bottles with special caps that recorded the date and time they opened their pill bottles to take medicine. Patients also took a survey before the study and again about 12 weeks later.
The research team compared the results for patients who did and who didn’t use the smartphone app. In addition, the team looked at whether the smartphone app might work better for certain types of patients. The study found that patients who had high anxiety, had a history of problems taking oral chemotherapy as planned, or were older than 55 appeared to benefit from the smartphone app. However, researchers need to do more studies to confirm these results.
What were the limits of the study?
The study took place in one hospital system. Most of the patients were white. Results may have been different for other hospital systems or groups of people. Using the special bottle caps that recorded when the patients opened their pill bottles may have made patients more likely to take their medicine, which may have changed the results of the study.
Future research could focus on patients who have a history of problems taking oral chemotherapy as planned, have high anxiety, or are older than 55.
How can people use the results?
Researchers can use these results to further study ways to help support patients who are taking oral chemotherapy.
Professional Abstract
Objective
To evaluate the effectiveness of a smartphone app in improving adherence to oral chemotherapy and patient-reported clinical outcomes
Study Design
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 181 adult patients with a prescription for oral chemotherapy who owned a smartphone |
Interventions/ Comparators |
|
Outcomes |
Primary: oral chemotherapy adherence, symptoms and side effects, quality of life Secondary: treatment satisfaction, urgent care visits |
Timeframe | 12-week follow-up for primary outcomes |
The research team conducted a randomized controlled trial to determine the effectiveness of a smartphone app for patients with cancer taking oral chemotherapy. The smartphone app included a medication treatment plan, reminder features, and a symptom-reporting module that sent weekly reports to patients’ oncologists. The app also included educational resources on cancer care and coping with side effects. To develop and test the app, the research team worked with patients, oncologists, cancer center administrators, and health system representatives.
The study included 181 adult patients with a prescription for oral chemotherapy. Patients received care at Massachusetts General Hospital in Boston or one of its three community affiliates. All patients owned a smartphone. Of these patients, 54% were women, 88% were white, and 12% were other races. The average age was 53. Patients had hematologic malignancies (33%), non-small cell lung cancer (18%), breast cancer (14%), high-grade gliomas (12%), and other solid tumors (23%).
The research team randomly assigned patients to one of two groups. In the first group, patients received usual care from their oncologists plus the smartphone app. Patients in the second group received only usual care from their oncologists. All patients used medication bottles with Medication Event Monitoring System (MEMS) caps, which recorded the date and time they opened their pill bottles to take their oral chemotherapy. Patients completed the same assessment survey prior to randomization and approximately 12 weeks later. To determine whether the smartphone app was more effective for certain types of patients than others, the team also conducted exploratory subgroup analyses.
Results
For oral chemotherapy adherence, symptoms and side effects, quality of life, treatment satisfaction, and urgent care visits, the study found no statistically significant differences between patients who used the smartphone app and those who did not use the app.
Exploratory subgroup analyses suggested that for patients who reported poor medication adherence and high anxiety at baseline, those in the smartphone app group showed greater improvement in MEMS cap adherence rates than those in the usual care group (both p<0.05). In addition, for patients who were older than 55, patients in the smartphone app group reported improved quality of life compared to those in the usual care group (p<0.05).
Limitations
The study took place in a single hospital system with a homogenous patient population, which may limit generalizability to other settings and patient populations. Only 22% of patients reported adherence problems at the start of the study, which may have affected the outcomes. Use of MEMS cap monitoring for all participants may have increased medication adherence in the usual care group, which could have weakened the intervention effect.
Conclusions and Relevance
Overall, the smartphone app did not improve adherence to oral chemotherapy or patient-reported outcomes compared with usual care. However, exploratory analyses showed that patients who self-reported poor medication adherence, had high anxiety, or were older than 55 may benefit from using the smartphone app.
Future Research Needs
Future research could explore the smartphone app’s effectiveness in different study settings or patient samples that are more diverse. To confirm findings from this study’s exploratory analyses, future studies could focus solely on patients who have a history of poor adherence, have high anxiety, or are older than 55 to confirm findings from this study’s exploratory analyses.
Final Research Report
View this project's final research report.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, the PI made changes including
- Expanding on the qualitative methods used in the research, and clarifying that the research should not be considered mixed methods since the qualitative work was done as part of engagement activities with study partners rather than as research with study participants.
- Revising the abstract, results, and discussion to acknowledge clearly that there was no significant difference between the intervention and comparison groups on the primary outcomes of adherence or self-reported symptoms, as well as overall quality of life or quality of care. Reviewers were concerned this was not clear because of the large number of subgroup and other analyses described in the report.
- Indicating that a small number of patients were recruited from community sites rather than from the academic medical center. Therefore, it was not possible to test for differences between sites.