Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer

NCT04506476 | Unknown

• 1 other identifier: OnkoFit I
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.

Conditions

Breast Cancer

Keywords

Fatigue; activity tracker; Radiotherapy; Exercise

Outcome Measures

Primary Outcomes (1)

• Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome

  This endpoint will be evaluated by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale of the FACIT 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; additional factors values 0-64, 64 worse outcome

  3 Months after completion of adjuvant radiotherapy of breast cancer

Study Arms (3)

Activity tracker with weekly goals

EXPERIMENTAL

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 physical 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

Activity tracker without Weekly goals

EXPERIMENTAL

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

Control arm with no activity tracker

NO INTERVENTION

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.

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, C DEVICE

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.

Activity tracker with weekly goals; Activity tracker without Weekly goals

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity for consent
• Minimum age 18
• Presence of breast cancer
• ECOG 0-2
• Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or Ablatio mammae

You may not qualify if:

• Participation in any other interventional study
• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Related Publications (1)

• Hauth F, Gehler B, Niess AM, Fischer K, Toepell A, Heinrich V, Roesel I, Peter A, Renovanz M, Hartkopf A, Stengel A, Zips D, Gani C. An Activity Tracker-Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials). JMIR Res Protoc. 2021 Sep 22;10(9):e28524. doi: 10.2196/28524.

  PMID: 34550079 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Cihan Gani, MD, PD

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cihan Gani, MD, PD

CONTACT

+49 (0) 7071 29-82165; cihan.gani@med.uni-tuebingen.de

Daniel Zips, MD, Prof

CONTACT

+49 (0) 7071 29-82165; ro-info@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

DE (1)