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INTEGRATION-Study

Combined nutrition and physical activity intervention during oncology intervention

Study Management

Inquiries and contact for the study:
Petra Armbrust (Tel.: 06221-56-38714, E-Mail: petra.armbrust@nct-heidelberg.de)

Study Management at the NCT:
Priv-Doz. Dr. Joachim Wiskemann, Prof. Dr. Dirk Jäger

Consortium Management:
Priv-Doz. Dr. Freerk T. Baumann, Univ.-Prof. Dr. Sebastian Theurich

Abstract

INTEGRATION is aimed at adults who have been diagnosed with cancer for the first time and who are about to start or have just started tumor therapy. They receive a needs-oriented, combined nutrition and exercise therapy to accompany the cancer treatment. The nutritional therapy aims to prevent malnutrition and includes needs-adapted and individualized nutrition plans. The exercise program involves strength and endurance training and incorporates other types of exercise training if indicated by patients need.
In the INTEGRATION study, an intervention group (combined nutrition and exercise therapy, group 1), is compared with a control group (group 2), which receives usual care at the clinical center. Both groups will be regularly assessed for nutritional status, exercise ability, and quality of life. Clinical data, functional tests, blood works and standardized questionnaires are used.

Numerous scientific studies show that exercise therapy can improve the tolerability of cancer treatment (especially chemo/radiation therapy) and patients’ quality of life. Early detection of nutritional problems and appropriate counseling/therapy help to avoid cancer treatment burden and improve the general condition of patients*.

The aim of this study is to integrate the INTEGRATION program as standard care in outpatient oncological treatment. The prerequisite is to provide evidence that the combination of nutrition and exercise therapy can be implemented in everyday clinical practice, that the occurrence of therapy-related side effects can be reduced and/or that the feasibility of oncological therapy can be improved.
The main objective is to reduce the proportion of patients with an increased need for exercise and nutritional care (calculation of a score from nutritional status, physical fitness and quality of life) at the latest 6 months after the end of your oncological therapy.

At the initial examination, as well as at the subsequent examinations after 6, 12, and 18 months, the various factors necessary to answer the scientific questions are recorded using questionnaire sets, physical fitness tests, and a survey of your nutritional status. These appointments last approximately 2.5 hours and include a blood sample and the wearing of a movement sensor for 1 week. During the cancer treatment phase, which in most cases extends over 4-6 months, appointments lasting approximately 1 hour are held every 4 weeks. If possible, we will combine the examination appointments with one of your other appointments in Heidelberg or at the NCT.

The study is financed by the Innovation Fund of the Federal Joint Committee (G-BA).


Current status


Patient recruitment is taking place at 11 participating centers in Germany and is expected to be completed by May 31, 2023 with a total of 54 patients*. Currently, 30 patients are participating in the study at the Heidelberg center (as of 12.05.2022).


At a glance

  • Study Objective:

The aim of the study is to integrate the INTEGRATION - program as standard care in outpatient oncological treatment. In addition, it is to be shown that the combination of a nutrition and exercise therapy can be implemented in everyday clinical practice, that the occurrence of therapy-related side effects can be reduced and/or that the feasibility of the oncological therapy can be improved.

  • Study patients:

First diagnosis of cancer prior to first-line outpatient systemic therapy (chemotherapy, chemotherapy plus surgery, or radiotherapy) with a duration of therapy of at least 4 months.  
Age ≥ 18 years

  • Study training:

Group 1: 2x/week supervised strength and endurance training (max. 60 min) + nutritional medical consultations every 2 weeks (20-30 min).

Group 2: You will receive from us all offers and consultations that are currently common in care and implemented in current guidelines and services of health insurance companies.

 

 

Cooperation partner:

  • Deutsche Gesellschaft für Ernährungsmedizin e.V. (DGEM), Chairman: Prof. Dr. Johann Ockenga
  • Deutscher Verband für Gesundheitssport und Sporttherapie (DVGS), Chairman: Prof. Dr. Gerhard Huber
  • Deutsche Sporthochschule Köln (DSHS) Abteilung für molekulare und zelluläre Sportmedizin, Head: Prof. Dr. Wilhelm Bloch
  • Arbeitskreis Ernährung, Stoffwechsel und Bewegung der Deutschen Gesellschaft für Hämatologie und Onkologie (DHGO), Head: Dr. Jann Arends