Evaluation of the Use of "Smart" Body-Weight Scales in Patients with Head and Neck Cancer Undergoing Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Adherence to treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Adherence to treatment
时间窗: Up to 8 weeks
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.
次要结局
- MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire scores(Baseline up to 3 months post-radiation therapy)
- Overall pain scores(Up to 3 months post-radiation therapy)
- Weight loss percentage(Up to 3 months post-radiation therapy)
研究者
Ravi Chandra
Principal Investigator
OHSU Knight Cancer Institute