Influence of a home-based nutrition and exercise program incorporating an app on the quality of life of outpatient palliative cancer patients
Zusammenfassung der Studie
We want to investigate in this study whether a combined exercise and nutrition program with a dietary supplement and a smartphone app has an impact on the personal quality of life of patients. Furthermore, we want to examine whether our therapy program can optimize nutritional status, muscle mass, physical performance, as well as energy and protein intake. Additionally, we would like to study the impact of these measures on fatigue and the clinical course of patients. We are also interested in how well patients adhere to the program and how many patients participate in the study.
(BASEC)
Untersuchte Intervention
The intervention group receives, in addition to regular medical treatment, nutritional therapy support through dietary counseling and professional, progressive physical training through physiotherapy, which is supported by the intake of a supplemental drink. Additionally, study participants receive an app for their smartphone, allowing them to store data and contact the study team.
(BASEC)
Untersuchte Krankheit(en)
Patients with tumor disease in the lung or gastrointestinal tract who are not treated curatively.
(BASEC)
- Individuals with a tumor in the lung or gastrointestinal tract who are not treated curatively - Able to engage in physical activity - Able to understand the relevant information and texts for the study (BASEC)
Ausschlusskriterien
- Supportive nutritional therapy (enteral nutrition, parenteral nutrition) in the last month - Acute intestinal obstruction in the last month - Allergy to milk protein (BASEC)
Studienstandort
Winterthur, Andere
(BASEC)
Thun
(BASEC)
Sponsor
Kantonsspital Winterthur
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Dr. phil. Christian Britschgi
+41 52 266 36 58
christian.britschgi@clutterksw.chKlinik für med. Onkologie und Hämatologie, Kantonsspital Winterthur
(BASEC)
Allgemeine Auskünfte
Kantonsspital Winterthur KSW
(ICTRP)
Wissenschaftliche Auskünfte
Kantonsspital Winterthur KSW
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
30.03.2021
(BASEC)
ICTRP Studien-ID
NCT04859400 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Influence of a home-based nutrition and exercise program including an application for monitoring on quality of life in advanced cancer outpatients (BASEC)
Wissenschaftlicher Titel
Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients (ICTRP)
Öffentlicher Titel
Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients (ICTRP)
Untersuchte Krankheit(en)
Cancer, Gastrointestinal;Cancer, Lung;Malnutrition (ICTRP)
Untersuchte Intervention
Dietary Supplement: Whey protein supplement high in leucine and ?-hydroxy-?-methylbutyrate (HMB);Behavioral: Standardized nutritional program;Behavioral: Standardized exercise program (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Advanced lung or gastrointestinal cancer patients not eligible for curative
treatment
- WHO performance status of = 2
- Able to perform physical exercise estimated by the treating physician
- Estimated life expectancy of = 6 months
- Patient must give written informed consent
Exclusion Criteria:
- Intake of supplements with high-dose branched-chain amino acids within one month
- Enteral (except oral nutritional supplements) and/or parenteral nutrition within one
month
- History of ileus within previous month
- Milk protein allergy
- The patient cannot understand the trial-specific content due to linguistic,
psychological or disease reasons
- Age < 18 years (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
QoL (ICTRP)
Nutritional status;Nutritional status;Nutritional status;Nutritional status;Nutritional status;Nutritional status;Physical function;Physical function;Physical function;Energy- and protein intake;Fatigue;Clinical data;Clinical data;Clinical data;Clinical data;Clinical data;Clinical data;Adherence to the nutritional and exercise program;Usability of the new application;Success of recruitment rate in comparison to former studies (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Krebsforschung Schweiz, Bern, Switzerland;Sponser Sport Food AG;Leitwert GmbH;SNAQ AG;Kantonsspital St. Gallen CTU (ICTRP)
Weitere Kontakte
Christian Britschgi, PD Dr. med. Dr. phil, Kantonsspital Winterthur KSW (ICTRP)
Sekundäre IDs
2020-02992 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04859400 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar