Tempei Miyaji1,2, Takashi Kawaguchi3, Kanako Azuma4, Shinya Suzuki5,6, Yoko Sano4, Moe Akatsu4, Ayako Torii4, Tadamasa Kamimura5, Yuki Ozawa5, Akihiko Tsuchida7, Daisuke Eriguchi8, Mizuha Hashiguchi9, Makoto Nishino9,10, Motohide Nishi11, Yumi Inadome11, Tsutomu Yamazaki12, Takahiro Kiuchi13, Takuhiro Yamaguchi14,15. 1. Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. tmiyaji@m.u-tokyo.ac.jp. 2. Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan. tmiyaji@m.u-tokyo.ac.jp. 3. Department of Practical Pharmacy, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1 Horinouchi, Hachioji City, Tokyo, 192-0392, Japan. 4. Department of Pharmacy, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. 5. Department of Pharmacy, Kanagawa Prefectural Keiyukai Keiyu Hospital, 3-7-3 Minatomirai, Nishi-ku, Yokohama-shi, Kanagawa, 220-8521, Japan. 6. Department of Hospital Pharmaceutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan. 7. Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. 8. Department of Thoracic Surgery, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. 9. Department of Internal Medicine, Kanagawa Prefectural Keiyukai Keiyu Hospital, 3-7-3 Minatomirai, Nishi-ku, Yokohama-shi, Kanagawa, 220-8521, Japan. 10. Department of Experimental Therapeutics, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. 11. Medidata Solutions K.K, JP Tower 29F 2-7-2, Marunouchi, Chiyoda-ku, Tokyo, 100-7029, Japan. 12. Clinical Research Support Center, The University of Tokyo Hospital, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. 13. Department of Heath Communication, School of Public Health, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. 14. Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. 15. Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.
Abstract
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.
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 cancerpatients 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 cancerpatients 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.
Authors: Moira A Visovatti; Mi Sook Jung; Heidi Mason; Mary Beth DeRubeis; Francis P Worden; Debra L Barton Journal: Cancer Nurs Date: 2022-01-12 Impact factor: 2.760
Authors: Ming-Yuan Chih; Anna McCowan; Sadie Whittaker; Melinda Krakow; David K Ahern; Eliah Aronoff-Spencer; Bradford W Hesse; Timothy W Mullett; Robin C Vanderpool Journal: J Appalach Health Date: 2020-11-17