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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05582 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19252 | Other Identifier | City of Hope Comprehensive Cancer Center |
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Funding issue
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (coaching call, motivational messages) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | Receive brief motivational text or email messages |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun | City of Hope Medical Center | Principal Investigator |
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| Exercise Intervention | Behavioral | Receive personalized walking program plus strength exercises |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive intervention coaching sessions via telephone |
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| Text Message | Other | Receive brief motivational text or email messages |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003143 | Communication Devices for People with Disabilities |
| ID | Term |
|---|---|
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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