TY - JOUR
T1 - Patient-generated health data collection using a wearable activity tracker in cancer patients—a feasibility study
AU - Miyaji, Tempei
AU - Kawaguchi, Takashi
AU - Azuma, Kanako
AU - Suzuki, Shinya
AU - Sano, Yoko
AU - Akatsu, Moe
AU - Torii, Ayako
AU - Kamimura, Tadamasa
AU - Ozawa, Yuki
AU - Tsuchida, Akihiko
AU - Eriguchi, Daisuke
AU - Hashiguchi, Mizuha
AU - Nishino, Makoto
AU - Nishi, Motohide
AU - Inadome, Yumi
AU - Yamazaki, Tsutomu
AU - Kiuchi, Takahiro
AU - Yamaguchi, Takuhiro
N1 - Funding Information:
We would like to thank all patients who participated in the study and their families, the students of Tokyo University of Pharmacy and Life Sciences (Mr. Yoshiki Tokuda, Ms. Yoshiko Nishi, Mr. Kiyomasa Kudo, and Ms. Yuina Motegi) for assisting with the data processing, and Editage (www.editage.jp) for English language editing.
Publisher Copyright:
© 2020, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2020/12
Y1 - 2020/12
N2 - Purpose: Incorporation of patient-generated health data (PGHD) into clinical research requires an investigation of the validity of outcomes and feasibility of implementation. This single-arm pilot trial investigated the feasibility of using a commercially available activity tracking wearable device in cancer patients to assess adherence to the device and real-time PGHD collection in a clinical research setting. Methods: From July to November 2017, enrolled adult patients were asked to wear a wristband-style device. Brief Fatigue Inventory (BFI) and MD Anderson Symptom Inventory (MDASI) were assessed at baseline and on day 29. Furthermore, 29-day Pittsburgh Sleep Quality Index, global impression of the devices, and NCI CTCAE v4 were evaluated. Results: Of 30 patients (mean age, 58.6 years; male, 21 [70%]), 15 (50%) and 11 (36.7%) had gastrointestinal and lung cancer, respectively, and 27 (90%, 95% CI: 0.74–0.98) were well adhered (> 70%) to the device for 28 days. The mean adherence was 84.9% (range: 41.7–95.2%). More frequent PGHD synchronization tended to show better device adherence, with moderate correlation (r = 0.62, 95% CI: 0.33–0.80, p < 000.1). Conclusions: The feasibility of using a wearable activity tracker was confirmed in cancer patients receiving chemotherapy for a month. For future implementation in clinical trials, there is a need for further comprehensive assessment of the validity and reliability of wearable activity trackers. Trial registration: This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN: UMIN000027575.
AB - Purpose: Incorporation of patient-generated health data (PGHD) into clinical research requires an investigation of the validity of outcomes and feasibility of implementation. This single-arm pilot trial investigated the feasibility of using a commercially available activity tracking wearable device in cancer patients to assess adherence to the device and real-time PGHD collection in a clinical research setting. Methods: From July to November 2017, enrolled adult patients were asked to wear a wristband-style device. Brief Fatigue Inventory (BFI) and MD Anderson Symptom Inventory (MDASI) were assessed at baseline and on day 29. Furthermore, 29-day Pittsburgh Sleep Quality Index, global impression of the devices, and NCI CTCAE v4 were evaluated. Results: Of 30 patients (mean age, 58.6 years; male, 21 [70%]), 15 (50%) and 11 (36.7%) had gastrointestinal and lung cancer, respectively, and 27 (90%, 95% CI: 0.74–0.98) were well adhered (> 70%) to the device for 28 days. The mean adherence was 84.9% (range: 41.7–95.2%). More frequent PGHD synchronization tended to show better device adherence, with moderate correlation (r = 0.62, 95% CI: 0.33–0.80, p < 000.1). Conclusions: The feasibility of using a wearable activity tracker was confirmed in cancer patients receiving chemotherapy for a month. For future implementation in clinical trials, there is a need for further comprehensive assessment of the validity and reliability of wearable activity trackers. Trial registration: This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN: UMIN000027575.
KW - Cancer
KW - Feasibility
KW - Patient-generated health data
KW - Validity
KW - Wearable activity tracker
KW - mHealth
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UR - http://www.scopus.com/inward/citedby.url?scp=85083764521&partnerID=8YFLogxK
U2 - 10.1007/s00520-020-05395-z
DO - 10.1007/s00520-020-05395-z
M3 - Article
C2 - 32281031
AN - SCOPUS:85083764521
VL - 28
SP - 5953
EP - 5961
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
SN - 0941-4355
IS - 12
ER -
