Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy

University Hospital Tuebingen201 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

201

Conditions

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

Interventions

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, CDEVICE

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

RECRUITING

Outcomes

Primary Outcomes

Evaluation of the impact of an Activity tracker based Fitness programme on the Qualitiy of Life after oncological Therapy

This endpoint will be evaluated by the FACT-G (Functional Assessment of Cancer Therapy - General) total scores of the FACIT (Functional Assessment of Chronic Illness Therapy) questionnaire (physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well-being values 0-28, 28 better outcome

Time frame: 6 Months after completion of adjuvant radiotherapy

Central Contacts

Cihan Gani, MD, PD

CONTACT

+49 (0) 7071 29 cihan.gani@med.uni-tuebingen.de

Daniel Zips, MD, Prof.

CONTACT

+49 (0) 7071 29 ro-info@med.uni-tuebingen.de

Data from ClinicalTrials.gov

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