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The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Malignant Head and Neck Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Device Qardio® smart scale Usage and Evaluation
Questionnaire Administration
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must have a histologically confirmed malignancy whereby pursual of radiation therapy has potential curative benefits for the patient.
  • Criteria for selection of head and neck malignancies include squamous cell carcinoma.
  • Ability to understand and the willingness to sign a written informed consent document.
  • For the intervention group, the ability to properly utilize a "smart" body weight scale after appropriate training has been provided. This includes access to wireless internet which can be paired with the "smart" body weight scale to transmit weight scale data.

Exclusion Criteria:

  • Do not meet the criteria for histologically confirmed malignancies.
  • Refuse or do not pursue radiation therapy for curative benefit of their malignancy.
  • Who do not understand or are unwilling to sign a written informed consent document.
  • For the intervention group, the inability to utilize or pair their "smart" body weight sales to wireless internet.
  • Members of vulnerable populations as below

  • Pregnant women, children, prisoners, neonates, and decisionally impaired adults will not be included in this study. Excluding vulnerable populations, all patients who are receiving or seeking medical care at Oregon Health & Science University (OHSU) for their head and neck cancer and meet inclusion criteria will be invited to participate in this study. Potential participants will be approached by a member of the clinic staff and will be asked to review a copy of the informed consent form prior to being seen by a treating physician. The investigator, or other qualified, designated healthcare provider will review the informed consent form with potential participants and address any questions or concerns prior to obtaining written informed consent for participation in this study. The investigator or other qualified, designated healthcare provider will also address any future questions or concerns of the participant.

    • Only individuals who have provided directly their written informed consent for participation in this study and meet inclusion criteria will be placed in the study. The participation of patients who are mentally incapacitated (e.g., comatose, unresponsive) will not be sought

Sites / Locations

  • Mid-Atlantic Permanente Medical Group
  • OHSU Knight Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cohort 2 (no weighing)

Cohort I ('Smart" scale weighing)

Arm Description

Patients do not weigh themselves using the "Smart" scale during standard radiation therapy.

Patients weigh themselves daily using the "Smart" scale over 5-8 weeks during standard radiation therapy.

Outcomes

Primary Outcome Measures

Adherence to treatment
Will include continuous variables (number of times participant stepped on the scale). Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.

Secondary Outcome Measures

MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores
The MDASI-HN has 13 core symptoms that is scored, at their worst over the last 24 hours, on a 0-10 numeric rating scale. A "0" means that a symptom is not present and a "10" is "as bad as you can imagine." Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Overall pain scores
Pain scores will be on a numeric rating scale, with lower numbers indicating lower pain values. Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Weight loss percentage
Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.

Full Information

First Posted
July 1, 2022
Last Updated
May 10, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Cambia Health Foundation, Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05457478
Brief Title
The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Official Title
Evaluation of the Use of "Smart" Body-Weight Scales in Patients With Head and Neck Cancer Undergoing Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Cambia Health Foundation, Oregon Health and Science University

4. Oversight

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

5. Study Description

Brief Summary
This clinical trial studies the use of "smart" body-weight scales to monitor weight and nutrition among patients with head and neck cancer undergoing radiation therapy. Malnutrition affects 30-50% of patients diagnosed with head and neck cancer, and approximately 30% of patients have malnutrition prior to diagnosis. "Smart" body weight scales can possibly make self-weighing easier, faster, and more accurate through weight recordings through mobile applications available for "smart" scales. This has the potential to maximize nutritional guidance through quick weight updates, possibly delaying or removing the use of patient enteral feeding (tube feeding). By avoiding or minimizing the use of enteral feeding during radiation therapy, the risk of long-term tube dependence and swallowing ability complications may be reduced.
Detailed Description
PRIMARY OBJECTIVE: I. To determine the feasibility of "smart" body scales in patients undergoing radiation therapy for head and neck cancer. SECONDARY OBJECTIVE: I. MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire, overall pain scores, and weight loss percentage. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients weigh themselves daily using the "Smart" scale over 5-8 weeks during standard radiation therapy. COHORT II: Patients do not weigh themselves using the "Smart" scale during standard radiation therapy. After completion of study intervention, patients are followed up within 2 weeks and 3 months post-radiation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma, Malignant Head and Neck Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 2 (no weighing)
Arm Type
Active Comparator
Arm Description
Patients do not weigh themselves using the "Smart" scale during standard radiation therapy.
Arm Title
Cohort I ('Smart" scale weighing)
Arm Type
Experimental
Arm Description
Patients weigh themselves daily using the "Smart" scale over 5-8 weeks during standard radiation therapy.
Intervention Type
Other
Intervention Name(s)
Medical Device Qardio® smart scale Usage and Evaluation
Other Intervention Name(s)
Smart body-weight scale
Intervention Description
Weight monitored using a Qardio® smart scale
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Adherence to treatment
Description
Will include continuous variables (number of times participant stepped on the scale). Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores
Description
The MDASI-HN has 13 core symptoms that is scored, at their worst over the last 24 hours, on a 0-10 numeric rating scale. A "0" means that a symptom is not present and a "10" is "as bad as you can imagine." Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Time Frame
Baseline up to 3 months post-radiation therapy
Title
Overall pain scores
Description
Pain scores will be on a numeric rating scale, with lower numbers indicating lower pain values. Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Time Frame
Up to 3 months post-radiation therapy
Title
Weight loss percentage
Description
Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.
Time Frame
Up to 3 months post-radiation therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have a histologically confirmed malignancy whereby pursual of radiation therapy has potential curative benefits for the patient. Criteria for selection of head and neck malignancies include squamous cell carcinoma. Ability to understand and the willingness to sign a written informed consent document. For the intervention group, the ability to properly utilize a "smart" body weight scale after appropriate training has been provided. This includes access to wireless internet which can be paired with the "smart" body weight scale to transmit weight scale data. Exclusion Criteria: Do not meet the criteria for histologically confirmed malignancies. Refuse or do not pursue radiation therapy for curative benefit of their malignancy. Who do not understand or are unwilling to sign a written informed consent document. For the intervention group, the inability to utilize or pair their "smart" body weight sales to wireless internet. Members of vulnerable populations as below Pregnant women, children, prisoners, neonates, and decisionally impaired adults will not be included in this study. Excluding vulnerable populations, all patients who are receiving or seeking medical care at Oregon Health & Science University (OHSU) for their head and neck cancer and meet inclusion criteria will be invited to participate in this study. Potential participants will be approached by a member of the clinic staff and will be asked to review a copy of the informed consent form prior to being seen by a treating physician. The investigator, or other qualified, designated healthcare provider will review the informed consent form with potential participants and address any questions or concerns prior to obtaining written informed consent for participation in this study. The investigator or other qualified, designated healthcare provider will also address any future questions or concerns of the participant. Only individuals who have provided directly their written informed consent for participation in this study and meet inclusion criteria will be placed in the study. The participation of patients who are mentally incapacitated (e.g., comatose, unresponsive) will not be sought
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ravi Chandra
Phone
503-494-8756
Email
chandrav@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Chandra
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid-Atlantic Permanente Medical Group
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Chandra
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Chandra
Phone
503-494-8756
Email
chandrav@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Ravi Chandra

12. IPD Sharing Statement

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The Use of "Smart" Body-Weight Scales for Weight and Nutritional Monitoring in Patients With Head and Neck Cancer Undergoing Radiation Therapy

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