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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457478
• Other study ID #: STUDY00022914
• Secondary ID: NCI-2022-05054ST
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: OHSU Knight Cancer Institute
• Contact: Ravi Chandra
• Phone: 503-494-8756
• Email: chandrav[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Malignant Head and Neck Neoplasm
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Medical Device Qardio® smart scale Usage and Evaluation
Weight monitored using a Qardio® smart scale
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Mid-Atlantic Permanente Medical Group	Rockville	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Cambia Health Foundation, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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