Head Neck Cancer
Conditions
Brief summary
Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control trial (RCT) using mobile health technology to enhance adherence and improve swallowing outcomes in patients undergoing radiation therapy for head and neck cancer.
Detailed description
Head and neck cancer (HNC) is the 6th most common type of cancer in the world and has recently seen a dramatic rise in the United States due to a rise in the incidence of oropharyngeal cancers related to the human papillomavirus (HPV) . The majority of patients diagnosed with HNC receive radiation therapy at some point in their treatment, either in the definitive or post-operative setting. Dysphagia is a common consequence of treatment for HNC, experienced by approximately 50% of patients treated with radiation therapy. Post-treatment dysphagia has been associated with increased risk of morbidity/mortality as well as well-recognized deterioration of quality of life. Performance of swallowing exercises during radiation significantly reduces dysphagia risk; however, patient adherence to swallowing exercises during radiation treatment is limited. Thus, poor adherence stands as a major obstacle to achieving the best swallowing outcomes. In response to this, a mobile health application was developed to directly address barriers cited by patients as reasons for non-adherence. The objective is to conduct a randomized controlled trial to test the impact of the mobile application on adherence to prophylactic swallowing therapy during radiation for HNC.
Interventions
OTHERVirtual Coach
The smartphone application, tailored to patients with HNC, will monitor patient progress while also providing a direct line to health care providers should any questions or concerns arise concerning their treatment. The mobile application will also feature instructional videos that describe the swallowing exercises in detail, providing patients with another resource to help improve their overall rehabilitation experience. Finally, home practice reminders and prompts will be used to help patients integrate the exercises into their daily routine.
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study subjects ≥ 18 years of age. * Fluent English speaking subjects. * Study subjects capable of providing informed consent. * Patients with newly diagnosed non-metastatic head and neck cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, and larynx that require bilateral neck radiation. Individuals with unknown primary head and neck cancer with nodal disease necessitating bilateral radiation will also be included. * Study subjects with a previously untreated head and neck cancer diagnosis requiring a definitive course of radiotherapy requiring a prescribed dose of 60Gy or greater. * Study subjects who have either an Android or Apple iOS-based smartphone or tablet compatible with the Vibrent application. * Study subjects who have access to a sufficient monthly data plan (approximately 200 MB/month), or Internet connection.
Exclusion criteria
* Non-English speaking, or incapable of providing informed consent. * Lack of smartphone, tablet, or Internet connection. * Inability to use the Vibrent application. * Patients being treated for head and neck cancer who do not receive some form of primary, adjuvant, or neo-adjuvant radiation therapy will not be considered for the study. * Patients with recurrent disease. * Pregnant women. * Individuals under the age of 18. * Individuals with contraindications to radiation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | 7 weeks | Measure of overall adherence to prescribed exercise protocol, by treatment group and radiation week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet Level as Defined by the Functional Oral Intake Scale (FOIS) | 19 weeks | 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. |
| Diet Restrictions as Measured by the Performance Status Scale Head and Neck | 7 weeks | 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) |
| Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI) | 19 weeks | 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. |
| Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS) | 19 weeks | 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. |
| Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale | 7 weeks | 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. |
| Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP) | 19 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
98 participants were screened, 91 participants were randomized to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| Virtual Coach App Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy. | 44 |
| 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. | 47 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued Intervention | 5 | 4 |
| Overall Study | Lost to Follow-up | 6 | 9 |
Baseline characteristics
| Characteristic | Virtual Coach App | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 61 years | 62 years | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 86 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 38 Participants | 82 Participants | 44 Participants |
| Region of Enrollment United States | 44 Participants | 91 Participants | 47 Participants |
| Sex/Gender, Customized Female | 5 Participants | 11 Participants | 6 Participants |
| Sex/Gender, Customized Male | 39 Participants | 79 Participants | 40 Participants |
| Sex/Gender, Customized Unknown/Not Reported | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 47 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises
Measure of overall adherence to prescribed exercise protocol, by treatment group and radiation week.
Time frame: 7 weeks
Population: Participants with available data at each respective timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual Coach App | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 1 | 18 Participants |
| Virtual Coach App | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 3 | 15 Participants |
| Virtual Coach App | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 7 | 6 Participants |
| Virtual Coach App | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 4 | 15 Participants |
| Virtual Coach App | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 2 | 19 Participants |
| Virtual Coach App | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 5 | 9 Participants |
| Virtual Coach App | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 6 | 9 Participants |
| Standard of Care | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 5 | 9 Participants |
| Standard of Care | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 6 | 10 Participants |
| Standard of Care | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 7 | 4 Participants |
| Standard of Care | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 1 | 17 Participants |
| Standard of Care | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 2 | 16 Participants |
| Standard of Care | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 3 | 13 Participants |
| Standard of Care | Number of Participants Achieving at Least 50% Adherence to Swallowing Exercises | Week 4 | 12 Participants |
Secondary
Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS)
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.
Time frame: 19 weeks
Population: Participants who completed the intervention and were blinded at consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Coach App | 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 |
| Standard of Care | Depth of Bolus Entry Into the Laryngeal Vestibule as Measured Using the Penetration-Aspiration Scale (PAS) | 2.42 score on a scale | Standard Deviation 1.7 |
p-value: 0.53Logistic Regression
Secondary
Diet Level as Defined by the Functional Oral Intake Scale (FOIS)
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.
Time frame: 19 weeks
Population: Participants who completed the intervention and were blinded at consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Coach App | Diet Level as Defined by the Functional Oral Intake Scale (FOIS) | 6.06 score on a scale | Standard Deviation 1 |
| Standard of Care | Diet Level as Defined by the Functional Oral Intake Scale (FOIS) | 5.94 score on a scale | Standard Deviation 1.5 |
p-value: 0.69Logistic Regression
Secondary
Diet Restrictions as Measured by the Performance Status Scale Head and Neck
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)
Time frame: 7 weeks
Population: Participants who completed the intervention and were blinded at consent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Coach App | 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 |
| Virtual Coach App | 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 |
| Standard of Care | Diet Restrictions as Measured by the Performance Status Scale Head and Neck | Normalcy of Diet | 76.94 score on a scale | Standard Deviation 7.1 |
| Standard of Care | Diet Restrictions as Measured by the Performance Status Scale Head and Neck | Eating in Public | 86.12 score on a scale | Standard Deviation 25.9 |
Comparison: Comparison of Eating in Public Scorep-value: 0.47Logistic Regression
Comparison: Comparison of Normalcy of Diet scorep-value: 0.73Logistic Regression
Secondary
Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI)
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.
Time frame: 19 weeks
Population: Participants who completed the intervention and were blinded at consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Coach App | Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI) | 75.66 score on a scale | Standard Deviation 13.6 |
| Standard of Care | Patient Perceived Swallowing Impairment as Measured by the MD Anderson Dysphagia Inventory (MDADI) | 76.35 score on a scale | Standard Deviation 17.1 |
p-value: 0.86Logistic Regression
Secondary
Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
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.
Time frame: 19 weeks
Population: Participants who completed the intervention and were blinded at consent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Coach App | 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 |
| Virtual Coach App | 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 |
| Standard of Care | Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP) | MBSImP Oral | 4.21 score on a scale | Standard Deviation 2.5 |
| Standard of Care | Physiological Oropharyngeal Swallowing Impairment as Measured by the Modified Barium Swallow Impairment Profile (MBS-ImP) | MBSImP Pharyngeal | 8.18 score on a scale | Standard Deviation 3.9 |
Comparison: Comparison of MBSImP Oral scorep-value: 0.65Logistic Regression
Comparison: Comparison of MBSImP Pharyngeal scorep-value: 0.24Logistic Regression
Secondary
Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale
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.
Time frame: 7 weeks
Population: Participants who completed the intervention and were blinded at consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Coach App | 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 |
| Standard of Care | Severity of Impairment of Swallowing Safety and Efficiency as Measured Using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale | 0.82 score on a scale | Standard Deviation 0.8 |
p-value: 0.5Logistic Regression