跳至主要内容
临床试验/NCT04085081
NCT04085081撤回不适用

Feasibility of a Perioperative Physical Activity Intervention for Older Adults With Lung Cancer and Their Family Caregivers

City of Hope Medical Center0 个研究点开始时间: 2021年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
>= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists

研究概览

简要总结

This trial studies whether a telephone-based physical activity intervention before and after lung cancer surgery can be provided to older patients and their caregivers. The trial also aims to understand whether patients and family caregivers will be satisfied with the intervention. Participating in physical activity such as walking before and after lung cancer surgery may improve functional status and recovery in older patients and their family caregivers.

详细描述

PRIMARY OBJECTIVE:

I. Administer and determine the feasibility of the perioperative physical activity intervention.

SECONDARY OBJECTIVES:

I. To describe patient and family caregiver outcome patterns and trajectory pre- and post-intervention.

II. Using qualitative methods, evaluate the acceptability of the intervention through brief, semi-structured interviews with patients and family caregivers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • PATIENTS: Must have histologically confirmed non-small cell lung cancer (NSCLC) or carcinoid tumor of the lung, and registration must occur after the first histologic diagnosis
  • PATIENTS: Must be registered at least 15 days before their scheduled surgery
  • PATIENTS: Must be scheduled for a lobectomy (open or minimally invasive)
  • PATIENTS: Must have access to a smartphone or telephone for study intervention sessions and study text messages
  • PATIENTS: Age >= 70 years
  • PATIENTS: Must be willing to wear a wristband pedometer for the duration of the study period, except on day of surgery
  • PATIENTS: Must be willing to answer telephone calls from the City of Hope Call Center
  • PATIENTS: Must have an identified family member or friend who is enrolled in the study
  • PATIENTS: Able to read and comprehend English. Study materials and telephone calls are only available in English
  • FAMILY CAREGIVERS: Family member or friend identified by the patient and will be caring for the patient before and after surgery
  • FAMILY CAREGIVERS: Age >= 18 years
  • FAMILY CAREGIVERS: Must have access to a smartphone or telephone for study intervention sessions and study text messages
  • FAMILY CAREGIVERS: Must be willing to wear a wristband pedometer for the duration of the study period
  • FAMILY CAREGIVERS: Must be willing to answer telephone calls from the City of Hope Call Center
  • FAMILY CAREGIVERS: Must have a care recipient (patient) who is enrolled in the study
  • FAMILY CAREGIVERS: Able to read and comprehend English. Study materials and telephone calls are only available in English

排除标准

  • 未提供

结局指标

主要结局

>= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists

时间窗: Up to 30 days post-hospital discharge

Will be evaluated based on data obtained throughout the study. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.

Adherence/engagement

时间窗: Up to 30 days post-hospital discharge

Will be determined by \>= 70% of enrolled participants who complete at least 2 intervention sessions. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.

Enrollment of >= 70% of eligible participants

时间窗: Up to 30 days post-hospital discharge

Will be evaluated based on data obtained throughout the study. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.

次要结局

  • Intervention acceptability as reported by participants(Up to 30 days post-hospital discharge)

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

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