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Table 2 Study design

From: Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)

Inclusion

n = 150

Stratified randomization

n = 50

Control group

n = 50

App group

n = 50

Therapist group

Therapy schedule

• 5x/week (30–40 min)

• 5x/week (30–40 min)

• 5x/week (30–40 min)

• 4 weeks

• 4 weeks

• 4 weeks

• Home practice

• Home practice but app-supported

• Therapist supervised

Exercises

• TSE

• TSE

• TSE

• CTAR

• CTAR

• CTAR

• Effortful swallow

• Effortful swallow

• Effortful swallow

Adherence measurements

• Supervision

No (home practice)

No (home practice – app)

Yes (face-to-face therapy)

• Counseling

Counseling 1x/week by SLP (10′)

Counseling 1x/week by SLP (10′) & continuous counseling via app

Counseling by SLP 5x/week

• Feedback on performance

Yes – instrumental

Yes – instrumental

Yes – instrumental & by SLP

• Clear and repeated instructions

• Introduction session

• Written instructions

• Introduction session

• Instructions via app: animation videos

• Each session by the SLP

• Target setting

Yes

Yes

Yes

• Limited duration

Yes – first 4 weeks of CRT

Yes – first 4 weeks of CRT

Yes – first 4 weeks of CRT

  1. TSE tongue-strengthening exercises, CTAR chin-tuck against resistance, SLP speech and language pathologist, CRT (chemo)radiotherapy