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

Not Applicable

Withdrawn

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

• Registration Number: NCT04085081
• Lead Sponsor: City of Hope Medical Center

Brief 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.

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 Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2021-05-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-12
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (coaching call, motivational messages)	Questionnaire Administration	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.
Supportive care (coaching call, motivational messages)	E-mail	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.
Supportive care (coaching call, motivational messages)	Exercise Intervention	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.
Supportive care (coaching call, motivational messages)	Telephone-Based Intervention	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.
Supportive care (coaching call, motivational messages)	Quality-of-Life Assessment	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.
Supportive care (coaching call, motivational messages)	Text Message	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.

Primary Outcome Measures

Name	Time	Method
>= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists	Up to 30 days post-hospital discharge	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.
Adherence/engagement	Up to 30 days post-hospital discharge	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.
Enrollment of >= 70% of eligible participants	Up to 30 days post-hospital discharge	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.

Secondary Outcome Measures

Name	Time	Method
Intervention acceptability as reported by participants	Up to 30 days post-hospital discharge	Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach.