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

Evaluation of the Use of "Smart" Body-Weight Scales in Patients with Head and Neck Cancer Undergoing Radiation Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Squamous Cell Carcinoma; Malignant Head and Neck Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Medical Device Qardio® smart scale Usage and Evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Mid-Atlantic Permanente Medical Group
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 2 (no weighing); Patients do not weigh themselves using the "Smart" scale during standard radiation therapy.	Other: Questionnaire Administration; Ancillary studies
Experimental: Cohort I ('Smart" scale weighing); Patients weigh themselves daily using the "Smart" scale over 5-8 weeks during standard radiation therapy.	Other: Questionnaire Administration; Ancillary studies; Other: Medical Device Qardio® smart scale Usage and Evaluation; Weight monitored using a Qardio® smart scale; Other Names: Smart body-weight scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 3 months post-radiation therapy
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.	Up to 3 months post-radiation therapy
Weight loss percentage	Standard statistical methods will be utilized to analyze cohort data, while also accounting for missing unused, or spurious data.	Up to 3 months post-radiation therapy

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; Cambia Health Foundation
• Investigators: Principal Investigator: Ravi Chandra, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Body Weight; Head and Neck Neoplasms
• Other Study ID Numbers: STUDY00022914 (OHSU Knight Cancer Institute); NCI-2022-05054 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No