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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Non-Small Cell Carcinoma; Lung Carcinoid Tumor; Caregiver; Lobectomy Patient
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: E-mail; Behavioral: Exercise Intervention; Behavioral: Telephone-Based Intervention; Other: Text Message

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (coaching call, motivational messages); 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: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: E-mail; Receive brief motivational text or email messages; Other Names: Electronic Mail; Email; Behavioral: Exercise Intervention; Receive personalized walking program plus strength exercises; Behavioral: Telephone-Based Intervention; Receive intervention coaching sessions via telephone; Other: Text Message; Receive brief motivational text or email messages; Other Names: Text; SMS Text; SMS Text Message

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; Lung cancer; functional status; family caregivers; geriatric oncology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoid Tumor
• Other Study ID Numbers: 19252 (Other Identifier: City of Hope Comprehensive Cancer Center); NCI-2019-05582 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No