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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04517019

Collaborator

(none)

201

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bronchial Carcinoma Esophageal Carcinoma Tumor of the Brain Head and Neck Cancer Pancreas Cancer Sarcoma Cervix Uteri Cancer	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	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

201 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A (Tracker/daily step-count suggestion) 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.	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 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.
Experimental: Arm B (Tracker/no daily step-count suggestion) 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.	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 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.
No Intervention: Arm C (no activity tracker) 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.

Arm

Intervention/Treatment

Experimental: Arm A (Tracker/daily step-count suggestion)

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.

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

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.

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

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.

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

No Intervention: Arm C (no activity tracker)

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.

Outcome Measures

Primary Outcome Measures

Evaluation of the impact of an Activity tracker based Fitness programme on the Qualitiy of Life after oncological Therapy [6 Months after completion of adjuvant radiotherapy]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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