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A Pilot Feasibility Study of an Online-based Exercise Program for Outpatients with Cancer

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	cancer
Date of first enrollment	21/05/2026
Target sample size	15
Countries of recruitment
Study type	Interventional
Intervention(s)	Single-arm, open-label, 8-week telerehabilitation exercise program for outpatients with cancer, delivered remotely by a physical or occupational therapist experienced in cancer rehabilitation. The program combines remote individual sessions with the therapist, remote group lessons, and self-directed exercise supported by a dedicated ICT application. Exercise type and intensity are individualized to each participant's condition and adjusted based on regularly collected patient-reported outcomes (PROs).

Outcome(s)

Primary Outcome

Completion rate of the 8-week telerehabilitation exercise program. A participant who completes the protocol-defined sessions within the prespecified allowance windows is considered a completer. Success criterion: completion rate 70% or higher (11/15 or more).

Secondary Outcome

(i) Safety: incidence and severity of exercise-related adverse events (e.g., fracture, spinal cord compression, falls, injury, excessive fatigue, worsening pain). (ii) Protocol adherence: lesson attendance rate (out of 4), individual-session attendance rate (out of 3), self-directed exercise completion rate. (iii) Change from baseline at week 8 in: EQ-5D-5L (index/VAS), daily step count, longest continuous walking time, 5-STS time, PRO-CTCAE scores.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Eligible patients must meet ALL of the following: 1. Histologically or cytologically confirmed diagnosis of any type of cancer. 2. Clinical stage I or higher. 3. Currently undergoing outpatient cancer treatment, or in an active follow-up phase within 5 years after diagnosis (regular imaging or blood tests at least once a year). 4. Aged 18 years or older at the time of informed consent. 5. ECOG Performance Status 0 to 2 and Karnofsky Performance Status 60% or higher. 6. Owns and is willing/able to use an ICT device (smartphone or tablet). 7. Has a safe space at home (or equivalent) for exercise: no protruding objects within 1.5 m radius, with a stable chair or wall available for support. 8. Able to communicate effectively in Japanese. 9. Provides written informed consent of their own free will.
Exclude criteria	Patients meeting any of the following will be excluded: 1. Estimated life expectancy of less than 3 months. 2. Diagnosed with terminal cancer and currently receiving primarily palliative home nursing care. 3. Any absolute contraindication to the intervention, including but not limited to: unstable angina or recent myocardial infarction (within 3 months); uncontrolled hypertension (resting SBP >180 mmHg or DBP >110 mmHg); severe aortic stenosis; acute systemic illness or fever; uncontrolled arrhythmia causing symptoms or hemodynamic instability; known meningeal carcinomatosis; spinal cord compression due to vertebral metastases with widespread advanced disease. 4. Severe cognitive impairment that prevents understanding of instructions or safe participation. 5. Refusal of regular hospital or outpatient visits, or consistently negative attitude, with no clearly scheduled next physician's appointment. 6. Currently participating in another interventional clinical trial of similar nature.