Squamous Cell Carcinoma of Head and Neck
Conditions
Brief summary
Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.
Detailed description
Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition. Patients in the experimental arm receive the daily reminder message via app (Emento) that they should pay attention to adequate caloric intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week. In case of relevant deterioration (any negative value in the screening questions is explained under study procedure), additional further questions are asked, which are specifically aimed at the side effects of the tumor therapy (mainly dysphagia, pain). The answers will be transmitted to the radiation clinic. If a question is answered positively, this is reported to the radiotherapy clinic on the one hand and on the other hand, the patient is asked to consult the doctor in the clinic as soon as possible.
Interventions
PROCEDUREApp Usage
Conducting patient surveys with app
OTHERStandard of Care
supportive care during and after radio(chemo)therapy according to hospial standards
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with squamous cell carcinoma in the head and neck region, who receive a postsurgical or definitive radio(chemo)therapy * Patients who have a smartphone on which the Emento app can be installed * Minimum age 18 years
Exclusion criteria
* Patients who are represented by a legal guardian * Patients who are not suitable for participation in the study due to a language barrier
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in rates of weight loss with additional app-based Patient Care | during trial, about 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of deteriorations in health status subjectively reported by patients and recorded via the app. | during trial, about 24 months |
| Frequency of additional app-triggered contacts of the clinic with the patients | during trial, about 24 months |
| Frequency of critical health conditions (physician-verified) detected earlier by the app. | during trial, about 24 months |
| Change in quality of life measured per questionnaires | during trial, about 24 months |
| Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy. | during trial, about 24 months |
| Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy. | during trial, about 24 months |
| Rate of therapy interruptions/discontinuations | during trial, about 24 months |
| Overall survival | during trial, about 24 months |
| Disease-free/progression-free survival | during trial, about 24 months |
| Change of Loco-regional tumor control | during trial, about 24 months |
Countries
Germany
Contacts
CONTACTStudiensekretariat
STUDY_DIRECTORMarlen Haderlein, PD
Universitätsklinikum Erlangen, Radiation Oncology
STUDY_DIRECTORLuitpold Distel, Prof.
Universitätsklinikum Erlangen, Radiation Oncology
PRINCIPAL_INVESTIGATORAllison Lamrani
Universitätsklinikum Erlangen, Radiation Oncology
PRINCIPAL_INVESTIGATORCharlotte Schmitter, Dr.
Universitätsklinikum Erlangen, Radiation Oncology
Outcome results
None listed