Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy (OnkoFit II)

University Hospital Tuebingen

Status: Enrolling

Conditions: Esophageal Carcinoma; Sarcoma; Bronchial Carcinoma; Pancreas Cancer; Tumor of the Brain; Head and Neck Cancer; Cervix Uteri Cancer

Treatments: Device: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C

Study type: Interventional

Funder types: Other

Identifiers

NCT04517019

OnkoFit II

Details and patient eligibility

About

Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.

Full description

This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in cancer patients on the Quality of life after oncological therapy. Quality of Life and the intensity of fatigue will be documented with the FACT-G total score of the FACIT Questionnaire six months after completion of radiotherapy.

Enrollment: 201 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Capacity for consent
• Minimum age 18
• Presence of one of the following tumor diseases: Bronchial Carcinoma, Esophageal Carcinoma, Tumor of the Brain, Head and Neck Cancer, Pancreas Cancer, Sarcoma Cervix Uteri Cancer
• ECOG 0-2
• Indication for a radiotherapy or a radiochemotherapy with an intended treatment time of minimum 4 weeks (definitive/adjuvant/neoadjuvant)

Exclusion criteria

• Participation in any other interventional study
• Radiotherapy of Breast cancer
• Pregnancy
• Contraindication against physical activity/sport and others
• Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA > I°)
• preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
• ECOG Status 3-4
• prior use of activity trackers

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

201 participants in 3 patient groups

Arm A (Tracker/daily step-count suggestion)

Experimental group

Description:

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients phyiscal activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy.

Treatment:

Device: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C

Arm B (Tracker/no daily step-count suggestion)

Experimental group

Description:

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps.

Treatment:

Device: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C

Arm C (no activity tracker)

No Intervention group

Description:

Patients receive a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided.