Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 5, 2021
Date Accepted: Jun 30, 2021
An activity tracker-guided physical activity program for patients undergoing radiotherapy. Study protocol for a prospective Phase III trial (OnkoFit I/II, ARO2020-2/3).
ABSTRACT
Background:
The positive impact of physical activity in cancer patients has been shown in several studies over recent years. However, supervised physical activity programs have several limitations, including costs and availability. Therefore, this study proposes a novel approach of implementation of a patient-executed, activity tracker-guided exercise program to bridge this gap.
Objective:
To investigate the impact of an activity tracker-guided, patient-executed exercise program in patients undergoing radiotherapy on cancer-related fatigue (CRF) and health-related Quality of Life (HRQoL).
Methods:
Patients receiving postoperative radiotherapy for breast cancer (OnkoFit I) or neoadjuvant, definitive or postoperative treatment for other solid tumors (OnkoFit II), will be randomized 1:1:1 in these three-armed studies. Target accrual is 201 patients in each trial. After informed consent, patients in arm A and B will wear an activity tracker and protocol their daily step count in a diary. While patients in arm A will receive personalized weekly targets for their physical activity, no further instructions will be given to patients in arm B. The primary endpoint of the OnkoFit I trial is CRF three months after completion of radiotherapy, measured by the FACIT-F questionnaire. For OnkoFit II, the primary endpoint is overall Quality of Life assessed by the FACT-G sum score six months after treatment to allow for recovery after possible surgery. In parallel blood samples before, during and after treatment will be collected in order to assess inflammatory markers.
Results:
Recruitment for both trials started on August 1st, 2020 and to date 26 and 11 patients have been included in the OnkoFit I and OnkoFit II trials, respectively. Both trials have been approved by the institutional review board prior to initiation of the trials.
Conclusions:
The OnkoFit trials test an innovative, personalized approach for the implementation of an activity tracker-guided training program for patients with cancer during radiotherapy, requiring only limited resources. Clinical Trial: NCT04506476 (OnkoFitI); NCT04517019 (OnkoFit II)
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