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NCT01898494 · OUTCOME

Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)

Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer · Source last updated 2026-04-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Assessed 4-6 weeks after surgery

What was measured

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).

Analysis population: Eligible and treated patients with MDADI scores after surgery available

Groups in this outcome

Arm S (Surgery) Then Arm A (Low Risk, Observation)

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.

Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.

Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.

Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm S (Surgery) Then Arm A (Low Risk, Observation)31
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)83
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)88
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)94

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm S (Surgery) Then Arm A (Low Risk, Observation)75.5Not reported66.085.0Not reported
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)76.3Not reported72.480.1Not reported
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)69.6Not reported65.174.1Not reported
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)73.3Not reported68.278.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        66.0
        upper Limit
        85.0
        value
        75.5
      2. group Id
        OG001
        lower Limit
        72.4
        upper Limit
        80.1
        value
        76.3
      3. group Id
        OG002
        lower Limit
        65.1
        upper Limit
        74.1
        value
        69.6
      4. group Id
        OG003
        lower Limit
        68.2
        upper Limit
        78.4
        value
        73.3
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      83
    3. group Id
      OG002
      value
      88
    4. group Id
      OG003
      value
      94
    units
    Participants
description
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
    id
    OG000
    title
    Arm S (Surgery) Then Arm A (Low Risk, Observation)
  2. description
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
    id
    OG001
    title
    Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
  3. description
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
    id
    OG002
    title
    Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
  4. description
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
    id
    OG003
    title
    Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
param Type
MEAN
population Description
Eligible and treated patients with MDADI scores after surgery available
reporting Status
POSTED
time Frame
Assessed 4-6 weeks after surgery
title
Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice