Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study

Abstract

Background: Increasing evidence shows that lifestyle interventions can improve the symptoms, quality of life (QoL), and even overall survival of patients with cancer. Digital therapeutics (DTx) can help implement behavioral modifications and empower patients through education, lifestyle support, and remote symptom monitoring.

Objective: We aimed to test the feasibility of a DTx program for patients with cancer, as measured by engagement, retention, and acceptability. In addition, we explored the effects of the program on cancer-related QoL.

Methods: We conducted a 4-week single-arm trial in Iceland, where DTx was delivered through a smartphone app. The intervention consisted of patient education about mindfulness, sleep, stress, and nutrition; lifestyle coaching; and the completion of daily missions for tracking physical activity and exercise, reporting patient-reported outcomes (PROs), practicing mindfulness, and logging healthy food intake. Information on program engagement and retention, step goal attainment, as well as PROs were collected throughout the study. QoL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 at baseline and follow-up.

Results: In total, 30 patients with cancer undergoing active therapy were enrolled, and 29 registered in the app (23 female, 18 with breast cancer; mean age 52.6, SD 11.5 years). Overall, 97% (28/29) of participants were active in 3 of the 4 weeks and completed the pre- and postprogram questionnaires. The weekly active days (median) were 6.8 (IQR 5.8-6.8), and 72% (21/29) of participants were active at least 5 days a week. Users interacted with the app on average 7.7 (SD 1.9) times per day. On week 1, all 29 participants used the step counter and logged an average of 20,306 steps; 21 (72%) participants reached their step goals of at least 3000 steps per day. On week 4, of the 28 active users, 27 (96%) were still logging their steps, with 19 (68%) reaching their step goals. Of the 28 participants who completed the satisfaction questionnaire, 25 (89%) were likely to recommend the program, 23 (82%) said the program helped them deal with the disease, and 24 (86%) said it helped them remember their medication. QoL assessment showed that the average global health status, functioning, and symptom burden remained stable from baseline to follow-up. In all, 50% (14/28) of participants reported less pain, and the average pain score decreased from 31 (SD 20.1) to 22.6 (SD 23.2; P=.16). There was no significant change in PROs on the quality of sleep, energy, and stress levels from the first to the last week.

Conclusions: The high retention, engagement, and acceptability found in this study demonstrate that multidisciplinary DTx is feasible for patients with cancer. A longer, full-scale randomized controlled trial is currently being planned to evaluate the efficacy of the intervention.

Keywords: cancer; digital therapeutics; lifestyle; mobile app; mobile phone; physical activity; quality of life; self-management.

Figure 1

The Sidekick app interface. Program overview (left): the program was composed of 4 weekly modules with introduction on week 1, followed by modules on stress and sleep, nutrition, and mindfulness in the following weeks. Users could access educational videos in each topic (middle) as part of their daily missions. The missions included reaching step goals and logging food and water intake (right).

Figure 2

Participant flow through the study.

Figure 3

Percentage of individuals with decreased, increased, or unchanged Quality of Life Questionnaire C30 scores on the functional and symptom scales. *1 missing value; n=27 answers were analyzed.

Figure 4

Average weekly changes in users’ ratings of energy levels, quality of sleep, and stress levels (error bars show SD), with the number of users reporting these (n) each week shown under the graphs.

Figure 5

Spearman rank correlation analysis of in-app quality of life (QoL) and Quality of Life Questionnaire C30 (QLQ-C30) item scores. The listed QLQ-C30 items below 0 are inversely correlated, while above 0, they are positively correlated with energy level, quality of sleep, and stress levels. Items that significantly correlate with either in-app QoL measure are shown in bold and are represented by large circles, while those items with no significant correlations are represented by small circles. *P≤.05; **P≤.01.