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

City of Hope

Status: Withdrawn

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

Treatments: Behavioral: Exercise Intervention; Other: E-mail; Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Text Message

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04085081

NCI-2019-05582 (Registry Identifier)

19252 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive care (coaching call, motivational messages)

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Based Intervention

Other: Text Message

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Behavioral: Exercise Intervention

Other: E-mail