Trial Outcomes & Findings for Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer (NCT NCT03832686)
NCT ID: NCT03832686
Last Updated: 2024-04-10
Results Overview
Measure of overall adherence to prescribed exercise protocol, by treatment group and radiation week.
COMPLETED
NA
98 participants
7 weeks
2024-04-10
Participant Flow
98 participants were screened, 91 participants were randomized to a study arm.
Participant milestones
| Measure |
Virtual Coach App
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
47
|
|
Overall Study
COMPLETED
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
Virtual Coach App
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
|
Overall Study
Discontinued Intervention
|
5
|
4
|
Baseline Characteristics
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Virtual Coach App
n=44 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=47 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
62 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Unknown/Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Participants with available data at each respective timepoint.
Measure of overall adherence to prescribed exercise protocol, by treatment group and radiation week.
Outcome measures
| Measure |
Virtual Coach App
n=38 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=40 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Week 1
|
18 Participants
|
17 Participants
|
|
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Week 2
|
19 Participants
|
16 Participants
|
|
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Week 3
|
15 Participants
|
13 Participants
|
|
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Week 4
|
15 Participants
|
12 Participants
|
|
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Week 5
|
9 Participants
|
9 Participants
|
|
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Week 6
|
9 Participants
|
10 Participants
|
|
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Week 7
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 19 weeksPopulation: Participants who completed the intervention and were blinded at consent.
The MD Anderson Dysphagia Inventory (MDADI) was selected to capture and quantify the patient perception of swallowing dysfunction. It is a 20-item patient reported survey that measures the impact of dysphagia on patients with HNC. Each item is scored on a 5 point scale with 1=lower function and 5=higher function. Possible scores range from 20-100 with higher scores indicating more normal swallowing function.
Outcome measures
| Measure |
Virtual Coach App
n=32 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=34 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI)
|
75.66 score on a scale
Standard Deviation 13.6
|
76.35 score on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: 19 weeksPopulation: Participants who completed the intervention and were blinded at consent.
Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 where lower scores reflect more limited oral intake and higher scores reflect more normal diet levels.
Outcome measures
| Measure |
Virtual Coach App
n=32 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=34 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Diet Level as Defined by the Functional Oral Intake Scale (FOIS)
|
6.06 score on a scale
Standard Deviation 1.0
|
5.94 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Participants who completed the intervention and were blinded at consent.
Performance Status Scale Head and Neck measures eating in public (range 0-100; higher number is indicative of better function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)
Outcome measures
| Measure |
Virtual Coach App
n=32 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=34 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Diet Restrictions as Measured by the Performance Status Scale Head and Neck
Eating in Public
|
90.15 score on a scale
Standard Deviation 19.4
|
86.12 score on a scale
Standard Deviation 25.9
|
|
Diet Restrictions as Measured by the Performance Status Scale Head and Neck
Normalcy of Diet
|
79.12 score on a scale
Standard Deviation 7.2
|
76.94 score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 19 weeksPopulation: Participants who completed the intervention and were blinded at consent.
The Modified Barium Swallow Impairment Profile is a tool designed to quantify degree of impairment on 13 individual physiologic components visualized during a modified barium swallow where higher numbers reflect greater dysfunction. Score range: 0-4 for each physiologic component. The maximum possible Oral score is 22 and the maximum possible pharyngeal score is 29.
Outcome measures
| Measure |
Virtual Coach App
n=32 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=34 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
MBSImP Oral
|
3.9 score on a scale
Standard Deviation 2.9
|
4.21 score on a scale
Standard Deviation 2.5
|
|
Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
MBSImP Pharyngeal
|
9.33 score on a scale
Standard Deviation 3.8
|
8.18 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 19 weeksPopulation: Participants who completed the intervention and were blinded at consent.
The Penetration Aspiration Scale measures the presence and depth of food/liquid material entering the airway and patient response to that material. This scale ranges from 1-8 with higher numbers indicating more abnormal function.
Outcome measures
| Measure |
Virtual Coach App
n=32 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=34 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS)
|
2.76 score on a scale
Standard Deviation 2.1
|
2.42 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Participants who completed the intervention and were blinded at consent.
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) rates the safety and efficiency of the swallow. Safety and efficiency are rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale also includes an overall impairment score which takes into consideration the safety and efficiency grade.
Outcome measures
| Measure |
Virtual Coach App
n=32 Participants
Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy.
|
Standard of Care
n=34 Participants
Participants are educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP and complete paper exercise logs.
|
|---|---|---|
|
Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale
|
0.97 score on a scale
Standard Deviation 1.0
|
0.82 score on a scale
Standard Deviation 0.8
|
Adverse Events
Virtual Coach App
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place