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

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Brief Title

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

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 Type

Interventional


Primary Outcome

Enrollment of >= 70% of eligible participants

Secondary Outcome

 Intervention acceptability as reported by participants

Condition

Caregiver

Intervention

E-mail

Study Arms / Comparison Groups

 Supportive care (coaching call, motivational messages)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

10

Start Date

November 1, 2020

Completion Date

November 1, 2022

Primary Completion Date

November 1, 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Virginia Sun, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04085081

Organization ID

19252

Secondary IDs

NCI-2019-05582

Responsible Party

Sponsor

Study Sponsor

City of Hope Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Virginia Sun, Principal Investigator, City of Hope Medical Center


Verification Date

September 2020