Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04085081
• Other study ID #: 19252
• Secondary ID: NCI-2019-0558219
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2021
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. OUTLINE: Patients and family caregivers complete comprehensive geriatric and functional assessments before surgery. This information is used to develop a personalized walking program plus simple lower extremity strength exercises. The intervention is administered by trained coaches with physical and occupational therapy background. The sessions are delivered by telephone before surgery (30-60 minutes), and on days 2, 7, 14, and 21 after hospital discharge (20-50 minutes). Participants will also receive brief motivational text or email messages (4 times per week between telephone sessions) to provide support, promote physical activity behavior change, and to sustain participant engagement. Patients and family caregivers are followed up to day 30 after hospital discharge.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Non-Small-Cell Lung
• Caregiver
• Lobectomy Patient
• Lung Carcinoid Tumor
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma

Intervention

Other:
• E-mail
Receive brief motivational text or email messages

Behavioral:
• Exercise Intervention
Receive personalized walking program plus strength exercises

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive intervention coaching sessions via telephone

Other:
• Text Message
Receive brief motivational text or email messages

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Outcome

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