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

NCT ID: NCT04085081

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-11-01

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.

Conditions

Caregiver; Lobectomy Patient; Lung Carcinoid Tumor; Lung Non-Small Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

E-mail

Intervention Type: OTHER

Receive brief motivational text or email messages

Exercise Intervention

Intervention Type: BEHAVIORAL

Receive personalized walking program plus strength exercises

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type: BEHAVIORAL

Receive intervention coaching sessions via telephone

Text Message

Intervention Type: OTHER

Receive brief motivational text or email messages

Interventions

E-mail

Receive brief motivational text or email messages

Intervention Type: OTHER

Exercise Intervention

Receive personalized walking program plus strength exercises

Intervention Type: BEHAVIORAL

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Telephone-Based Intervention

Receive intervention coaching sessions via telephone

Intervention Type: BEHAVIORAL

Text Message

Receive brief motivational text or email messages

Intervention Type: OTHER

Other Intervention Names

Electronic Mail; Email; Quality of Life Assessment; SMS Text; SMS Text Message; Text

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia Sun

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Other Identifiers

NCI-2019-05582

Identifier Type: REGISTRY

Identifier Source: secondary_id

19252

Identifier Type: OTHER

Identifier Source: secondary_id

19252

Identifier Type: -

Identifier Source: org_study_id