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Clinical Trials/NCT04085081
NCT04085081
Withdrawn
Not Applicable

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

City of Hope Medical Center0 sitesMay 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregiver
Sponsor
City of Hope Medical Center
Primary Endpoint
>= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2021
End Date
November 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

>= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Intervention acceptability as reported by participants(Up to 30 days post-hospital discharge)

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