Clinical trial NCT04085081: Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers
Official title: Feasibility of a Perioperative Physical Activity Intervention for Older Adults With Lung Cancer and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Caregiver
Lobectomy Patient
Lung Carcinoid Tumor
Lung Non-Small Cell Carcinoma
Keywords: Lung cancer
geriatric oncology
physical activity
family caregivers
functional status
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Enrollment of >= 70% of eligible participants
timeFrame: Up to 30 days post-hospital discharge
measure: >= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists
timeFrame: Up to 30 days post-hospital discharge
measure: Adherence/engagement
timeFrame: Up to 30 days post-hospital discharge
Secondary outcomes:
measure: Intervention acceptability as reported by participants
timeFrame: Up to 30 days post-hospital discharge
Other outcomes:
measure: Patient and family caregiver outcome patterns and trajectories before and after the intervention
timeFrame: Baseline up to 30 days post-hospital discharge
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References: