2.3. Interventional methods

Upon study enrollment, participants complete baseline self-report measures, after which they are randomly assigned to either the THRIVE mobile app (intervention) with usual oncology care group or the usual oncology care alone group (control).

For patients randomized to the THRIVE intervention, the RA provides them with a study-issued tablet computer from which the participants access the mobile app or assists the patient in downloading the app onto a suitable device already owned by the participant. The mobile app is optimized for the iOS operating system. The RA provides intervention patients with a comprehensive tutorial and detailed instructions regarding how to use the app and is available throughout the study to provide technological support if needed. Intervention patients also receive a handout with application download instructions, an informational video sent securely via email, and a user guide. Patients complete the mobile app intervention modules at their desired pace over approximately 10 weeks. The app prompts patients with reminders to complete their modules and utilizes incentives to enhance patient engagement. Table 1 details the components of the THRIVE mobile app modules. The mobile app electronically collects data on intervention fidelity (e.g., the number of completed modules, proportion of each module completed, time spent on each module, etc.).

Finally, we conduct qualitative interviews with up to 30 patients who are randomized to the intervention group to learn about their experiences with the THRIVE mobile app. We purposively sample patients to ensure adequate representation based on age and gender. The semi-structured interviews are conducted after the 12-week post assessment time point.

Patients assigned to the usual oncology care group receive standard cancer care without the THRIVE mobile app. As part of usual care, we query the electronic health record to track and record participant use of any supportive care services, such as social work, psychology, psychiatry, and palliative care. While we expect the referral and use of these services to be low and balanced between study groups, we will include these variables as covariates in the outcome analyses as needed.

The study staff administers the following validated, self-report questionnaires at baseline prior to randomization and at approximately 12 weeks (+/− 2 weeks) after baseline. Participants are given a four-week time frame surrounding the 12-week time point to complete the measures. This window, which has consistently been used by our research group, allows for greater flexibility for participants to complete these measures given their degree of medical morbidity. These measures can be administered via paper hard-copy or electronically using Research Electronic Data Capture (REDCap), a secure, online HIPAA-compliant survey tool (Harris et al., 2009). The RA asks study participants to complete questionnaires in-person during clinic visits, via email, or over the telephone if necessary.

Study staff collects data from the electronic health record regarding patient age, cancer diagnosis, ECOG performance status, cancer therapy information, emergency department visits, hospitalizations, hospice referral, and use of supportive care services.