跳至主要内容
临床试验/NCT05118802
NCT05118802已完成不适用

Measuring the Impact of MANNA s Medically Tailored Meal Program in Patients With a Non-terminal Cancer Diagnosis

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians

研究概览

简要总结

This study identifies patient-important outcome measures and develops a survey that assesses the impact of nutritional interventions among cancer patients. Currently, data on the impact of medically tailored meals on outcomes that are meaningful to patients, providers, and payers are limited. For this reason, access to medically tailored meals as a covered benefit for cancer patients is limited. Thus, there is a need to explore the efficacy of nutritional interventions among this population. This study identifies outcome measures for nutritional interventions that are meaningful to patients and providers.

详细描述

PRIMARY OBJECTIVES:

I. To identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians.

II. To conduct cognitive interviews to assess comprehension, acceptability, and appropriateness of patient-identified outcomes in aim 1.

III. To pilot test the use of the nutrition-related outcome measures identified in aim 1 among a sample of oncology patients.

OUTLINE:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AIM 1 PATIENTS: SKCC oncology patients
  • AIM 1 PATIENTS: Currently receiving cancer treatment
  • AIM 1 PATIENTS: 18 years or older
  • AIM 1 PATIENTS: English speaking
  • * Pending funding and staff abilities, efforts will be made to include other languages if possible
  • AIM 1 PATIENTS: 10 patients have received MANNA services in past 6 months
  • AIM 1 PATIENTS: 10 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and report food insecurity
  • * Nutrition risk = a score of >= 2 on the Malnutrition Screening Tool, weight loss of 5% over 1 months, or weight loss of > 10% over 6 months
  • AIM 1 PATIENTS: 10 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and do not report food insecurity
  • AIM 1 CLINICIANS: Providing care/support for oncology patients
  • AIM 1 CLINICIANS: English speaking
  • AIM 2 PATIENTS: Current SKCC oncology patient
  • AIM 2 PATIENTS: 18 years or older
  • AIM 2 PATIENTS: English speaking
  • Pending funding and staff abilities, efforts will be made to include other languages if possible
  • AIM 2 PATIENTS: 3-5 patients have received MANNA services in past 6 months
  • AIM 2 PATIENTS: 3-5 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and report food insecurity
  • * Nutrition risk = a score of >= 2 on the Malnutrition Screening Tool, weight loss > 5% over 1 month, or weight loss of > 10% over 6 months
  • AIM 2 PATIENTS: 3-5 patients currently receiving cancer treatment for curative intent, screen positive for nutrition risk, and do not report food insecurity
  • AIM 3 SKCC PATIENTS: Receiving active cancer treatment for curative intent
  • AIM 3 SKCC PATIENTS: Meet MANNA eligibility criteria
  • AIM 3 SKCC PATIENTS: Have a phone number or email address for contacting
  • AIM 3 SKCC PATIENTS: 18 years or older *Pending funding and staff abilities, efforts will be made to include other languages if possible
  • AIM 3 MANNA CLIENTS: Have any cancer diagnosis
  • AIM 3 MANNA CLIENTS: Currently receiving MANNA meals
  • AIM 3 MANNA CLIENTS: Have a phone number or email address for contacting
  • AIM 3 MANNA CLIENTS: 18 years or older
  • AIM 3 MANNA CLIENTS: English speaking * Pending funding and staff abilities, efforts will be made to include other languages if possible

排除标准

  • AIM 1 PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
  • AIM 1 PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)
  • AIM 1 PATIENTS: Homelessness
  • AIM 1 CLINICIANS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
  • AIM 2 PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
  • AIM 2 PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)
  • AIM 2 PATIENTS: Homelessness
  • AIM 3 SKCC PATIENTS: Unable to provide consent (as assessed by team member conducting enrollment, with use of teachback)
  • AIM 3 SKCC PATIENTS: Lives in a facility that provides nutrition services (e.g., nursing home, rehab facility, incarcerated, emergency shelter)
  • AIM 3 SKCC PATIENTS: Homelessness
  • AIM 3 MANNA CLIENTS: Unable to provide consent (as assessed by team members conducting enrollment, with use of teachback)
  • AIM 3 MANNA CLIENTS: Homelessness

结局指标

主要结局

identify patient-important outcomes related to receiving nutrition services by engaging patients with cancer and clinicians

时间窗: At study completion; approximately 60 minutes

Reported as average time required to complete each assessment.

Feasibility

时间窗: At study completion; approximately 60 minutes

Reported as the number of participants who are able to complete the entire list of assessments to receive nutrition services.

Usability

时间窗: At study completion; approximately 60 minutes

Reported as average time required to complete each assessment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验