Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App Usage | Experimental | Patients receive the daily reminder message via app (Emento) that they should pay attention to sufficient calorie intake. In addition, these patients receive 3 screening questions about their current health and nutritional status twice a week. |
|
| Standard | Other | Patients in the control arm receive supportive care during and after radio(chemo)therapy according to hospital standards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App Usage | Procedure | Conducting patient surveys with app |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rates of weight loss with additional app-based Patient Care | during trial, about 24 months |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Studiensekretariat | Contact | +49913185 | 33968 | studiensekretariat.ST@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Marlen Haderlein, PD | Universitätsklinikum Erlangen, Radiation Oncology | Study Director |
| Luitpold Distel, Prof. | Universitätsklinikum Erlangen, Radiation Oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen, Strahlenklinik | Recruiting | Erlangen | Bavaria | 91054 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care |
| Other |
supportive care during and after radio(chemo)therapy according to hospial standards |
|
| 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 |
| Allison Lamrani |
| Universitätsklinikum Erlangen, Radiation Oncology |
| Principal Investigator |
| Charlotte Schmitter, Dr. | Universitätsklinikum Erlangen, Radiation Oncology | Principal Investigator |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided