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Table 1 Study design—intervention versus control group

From: The effects of Phoniatric PREhabilitation in Head and Neck Cancer patients on Aspiration and Preservation of Swallowing (PREHAPS): study protocol of a monocentric prospective randomized interventional outcome-blinded trial

Measures’ description

Study arms

 

Intervention

Control

Pre-therapeutic standard

 Standardized non-phoniatric, medical assessment of swallowing function, if necessary phoniatric-logopedic diagnostics and therapy according to standard; in some cases low-frequency therapy already before/during therapy, usually by cost adaptation

X

X

 Tumor board

X

X

 Medical information (diagnosis, surgery or radiotherapy)

X

X

 Psycho-oncological screening (Hornheider questionnaire), intervention if necessary

X

X

 Contact and advise social service

X

X

 PEG, if necessary

X

X

 Nutritional Risk Screening (NRS)—prescreening in nursing history

X

X

 Proactive information about smoking cessation (flyer)

X

X

Baseline values (both groups, in addition to the previous standard)

 EORTC-QLQ-C30 [10], EORTC-QLQ-HN43 [11], Dysphagia-Handicap-Index (DHI) [12], Hospital Anxiety and Depression Scale (HADS) [13]

X

X

 NRS main screening, risk-related nutritional counseling (face-to-face); bioelectrical impedance analysis

X

X

 Phoniatric diagnostics (FEES) regarding oral feeding restrictions and aspiration risk: Penetration Aspiration Scale (PAS) [15]; Functional Oral Intake Scale (FOIS-G) [14]; Yale Residual Scale [16]

X

X

Intervention

 Phoniatric-logopedic PREhabilitation

General information and counseling, also for prevention of dysphagia before/during therapy, video demonstration [17], if necessary also by accompanying relatives, exercises to strengthen and improve the range of motion of oral, pharyngeal, and laryngeal muscles (tongue, larynx, jaw, e.g., Mendelsohn, Shaker maneuvers, “effortful swallow,” supraglottic swallowing technique) and sensitivity. Therapeutic approach according to individual protocol. Instructions for home exercise (eating rules, individual exercise protocol with recommended dosage, instructions for exercise diary)

X

-

 Follow-up interview, based on exercise diary, after max. 1 week, by phoniatrics, speech therapy and nutrition counseling, face-to-face or by telephone

X

-

Oncological therapy

Postinterventional outcome measures at 6 weeks and 3, 6, and 12 months after the end of oncologic therapy

  Questionnaires: EORTC-QLQ-C30 [10]), EORTC-QLQ-HN43 [11]), FACE-Q Head and Neck Cancer [19]), Dysphagia-Handicap-Index (DHI) [12]), Hospital Anxiety and Depression Scale (HADS) [13])

X

X

  Phoniatric-logopedic follow-up (FEES) regarding oral feeding restrictions and aspiration risk, Penetration Aspiration Scale (PAS) [12]; Functional Oral Intake Scale (FOIS-G) [14]; Yale Residual Scale [13] and on the progress of therapy (exercise diary)

X

X

Follow-up treatment (AHB) after 6 weeks, according to patient preference