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| ID | Type | Description | Link |
|---|---|---|---|
| ENT0070 | Other Identifier | OnCore | |
| NCI-2019-04958 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Coach App | Experimental | Participants in the experimental arm (Group A) will receive a comprehensive swallowing rehabilitation app. This study seeks to determine if a mobile application may enhance adherence to swallowing therapy in patients undergoing radiation therapy for head and neck cancer. No devices - outside of the Smartphone already owned by the participant - will be used in this study. Similarly, no drugs, biological materials, or other substances will be used. |
|
| Standard of Care | No Intervention | The paper group (Group B) will be given paper exercise logs to fill out Participants will be educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP. The paper log treatment group will serve as a standard treatment group. As adherence is a primary goal of the target intervention, paper logging will be necessary to determine relative adherence while minimizing reporting bias. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Coach | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Starmer | Stanford Universiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Palo Alto | California | 94304 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35960394 | Result | Starmer HM, Klein D, Montgomery A, Goldsmith T, McCarroll L, Richmon J, Christopher Holsinger F, Beadle B, Jain P. Head and Neck Virtual Coach: A Randomized Control Trial of Mobile Health as an Adjunct to Swallowing Therapy During Head and Neck Radiation. Dysphagia. 2023 Jun;38(3):847-855. doi: 10.1007/s00455-022-10506-5. Epub 2022 Aug 12. |
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98 participants were screened, 91 participants were randomized to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Coach App | Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Coach App | Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with available data at each respective timepoint. | Posted | Count of Participants | Participants | 7 weeks |
|
Up to 19 weeks
Per protocol, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Coach App | Participants use a comprehensive swallowing rehabilitation app to determine if a mobile application may enhance adherence to swallowing therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Starmer, MD | Stanford University | 650-529-5903 | hstarmer@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2021 | Dec 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 19 weeks |
| 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. | 19 weeks |
| 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) | 7 weeks |
| 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. | 19 weeks |
| 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. | 19 weeks |
| 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. | 7 weeks |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Participants who completed the intervention and were blinded at consent. | Posted | Mean | Standard Deviation | score on a scale | 19 weeks |
|
|
|
|
| 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. | Participants who completed the intervention and were blinded at consent. | Posted | Mean | Standard Deviation | score on a scale | 19 weeks |
|
|
|
|
| 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) | Participants who completed the intervention and were blinded at consent. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| 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. | Participants who completed the intervention and were blinded at consent. | Posted | Mean | Standard Deviation | score on a scale | 19 weeks |
|
|
|
|
| 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. | Participants who completed the intervention and were blinded at consent. | Posted | Mean | Standard Deviation | score on a scale | 19 weeks |
|
|
|
|
| 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. | Participants who completed the intervention and were blinded at consent. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 47 | 0 | 0 | 0 | 0 |
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| Logistic Regression |
| 0.73 |
A p-value of <0.05 would be considered statistically significant. |
| Other |
| Logistic Regression |
| 0.24 |
A p-value of <0.05 would be considered statistically significant. |
| Other |