App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who are represented by a legal guardian

Patients who are not suitable for participation in the study due to a language barrier

Trial design

Design model

Parallel

Treatments tested in this trial

  • App Usage

    Procedure/Surgery

    Conducting patient surveys with app

  • Standard of Care

    Other intervention

    supportive care during and after radio(chemo)therapy according to hospial standards

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: App UsageExperimental treatment 1 intervention
Group B: StandardOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in rates of weight loss with additional app-based Patient Care

Time frame
during trial, about 24 months

Secondary outcomes

1

Frequency of deteriorations in health status subjectively reported by patients and recorded via the app.

Time frame
during trial, about 24 months
2

Frequency of additional app-triggered contacts of the clinic with the patients

Time frame
during trial, about 24 months
3

Frequency of critical health conditions (physician-verified) detected earlier by the app.

Time frame
during trial, about 24 months
4

Change in quality of life measured per questionnaires

Time frame
during trial, about 24 months

Other outcomes

Sponsors and contacts

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