Clinical trial NCT05457478: 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
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Malignant Head and Neck Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Cambia Health Foundation
name: Oregon Health and Science University
First posted: 2022-07-14
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adherence to treatment
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores
timeFrame: Baseline up to 3 months post-radiation therapy
measure: Overall pain scores
timeFrame: Up to 3 months post-radiation therapy
measure: Weight loss percentage
timeFrame: Up to 3 months post-radiation therapy
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Mid-Atlantic Permanente Medical Group
state: Maryland
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Ravi Chandra
role: PRINCIPAL_INVESTIGATOR
References: