App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: App Usage, Standard of Care.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of Head and Neck. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure App Usage
Conducting patient surveys with app - Other Standard of Care
supportive care during and after radio(chemo)therapy according to hospial standards
Primary outcome measures
- Change in rates of weight loss with additional app-based Patient Care [Time frame: during trial, about 24 months]
Secondary outcome measures (10)
- Frequency of deteriorations in health status subjectively reported by patients and recorded via the app. [Time frame: during trial, about 24 months]
- Frequency of additional app-triggered contacts of the clinic with the patients [Time frame: during trial, about 24 months]
- Frequency of critical health conditions (physician-verified) detected earlier by the app. [Time frame: during trial, about 24 months]
- Change in quality of life measured per questionnaires [Time frame: during trial, about 24 months]
- Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy. [Time frame: during trial, about 24 months]
- Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy. [Time frame: during trial, about 24 months]
- Rate of therapy interruptions/discontinuations [Time frame: during trial, about 24 months]
- Overall survival [Time frame: during trial, about 24 months]
- Disease-free/progression-free survival [Time frame: during trial, about 24 months]
- Change of Loco-regional tumor control [Time frame: during trial, about 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- Universitätsklinikum Erlangen, Strahlenklinik — Erlangen
Identifiers
NCT: NCT06367257 · Emento App