Lung Non-Small Cell Carcinoma Clinical Trial
Official title:
Feasibility of a Perioperative Physical Activity Intervention for Older Adults With Lung Cancer and Their Family Caregivers
Verified date | August 2021 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 1, 2022 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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City of Hope Medical Center | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient and family caregiver outcome patterns and trajectories before and after the intervention | Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to explore patterns and trajectories over time. | Baseline up to 30 days post-hospital discharge | |
Primary | Enrollment of >= 70% of eligible participants | 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. | Up to 30 days post-hospital discharge | |
Primary | >= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists | 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. | Up to 30 days post-hospital discharge | |
Primary | Adherence/engagement | 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. | Up to 30 days post-hospital discharge | |
Secondary | Intervention acceptability as reported by participants | Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach. | Up to 30 days post-hospital discharge |
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