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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: E-mail
* Behavioral: Exercise Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention
* Other: Text Message


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (coaching call, motivational messages)<br>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. | Other: E-mail<br>* Receive brief motivational text or email messages<br>* Other names: Email;Behavioral: Exercise Intervention<br>* Receive personalized walking program plus strength exercises<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive intervention coaching sessions via telephone<br>Other: Text Message<br>* Receive brief motivational text or email messages<br>* Other names: Text;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| >= 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, geriatric oncology, physical activity, family caregivers, functional status