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Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer

Primary Purpose

Head Neck Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Coach
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Cancer Institute
  • Dana-Farber Cancer Institute
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Coach App

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall adherence to prescribed exercise protocol measured as percentage of prescribed exercises completed
Percentage of prescribed exercises completed over a 7-week treatment period

Secondary Outcome Measures

Patient perceived swallowing impairment as measured by the MD Anderson Dysphagia Inventory
Mean MD Anderson Dysphagia Inventory score by treatment group
Diet level as defined by the Functional Oral Intake Scale
Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 with higher numbers indicating more normal diet
Diet restrictions as measured by the Performance Status Scale Head and Neck
Performance Status Scale Head and Neck provides a measure of eating in public (range 0-100; higher number is indicative of better function), understandability of speech (range 0-100, higher number is indicative of more normal function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)
Physiological oropharyngeal swallowing impairment as measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
Mean composite Modified Barium Swallow Impairment Profile score by treatment group
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.
Severity of impairment of swallowing safety and efficiency as measured using the Dynamic Imaging Grade of Swallowing Toxicity scale
Dynamic Imaging Grade of Swallowing Toxicity rates the safety and efficiency of the swallow. Each parameter is rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale includes the safety score, the efficiency score, and an overall impairment score which takes into consideration the safety and efficiency grade.

Full Information

First Posted
January 28, 2019
Last Updated
April 6, 2023
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03832686
Brief Title
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
Official Title
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Neck Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Coach App
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall adherence to prescribed exercise protocol measured as percentage of prescribed exercises completed
Description
Percentage of prescribed exercises completed over a 7-week treatment period
Time Frame
up to 7 weeks
Secondary Outcome Measure Information:
Title
Patient perceived swallowing impairment as measured by the MD Anderson Dysphagia Inventory
Description
Mean MD Anderson Dysphagia Inventory score by treatment group
Time Frame
7 weeks
Title
Diet level as defined by the Functional Oral Intake Scale
Description
Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 with higher numbers indicating more normal diet
Time Frame
7 weeks
Title
Diet restrictions as measured by the Performance Status Scale Head and Neck
Description
Performance Status Scale Head and Neck provides a measure of eating in public (range 0-100; higher number is indicative of better function), understandability of speech (range 0-100, higher number is indicative of more normal function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)
Time Frame
7 weeks
Title
Physiological oropharyngeal swallowing impairment as measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
Description
Mean composite Modified Barium Swallow Impairment Profile score by treatment group
Time Frame
7 weeks
Title
Depth of bolus entry into the laryngeal vestibule as measured using the Penetration-Aspiration Scale (PAS)
Description
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
7 weeks
Title
Severity of impairment of swallowing safety and efficiency as measured using the Dynamic Imaging Grade of Swallowing Toxicity scale
Description
Dynamic Imaging Grade of Swallowing Toxicity rates the safety and efficiency of the swallow. Each parameter is rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale includes the safety score, the efficiency score, and an overall impairment score which takes into consideration the safety and efficiency grade.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Starmer
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer

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