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

Primary Purpose

Caregiver, Lobectomy Patient, Lung Carcinoid Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
E-mail
Exercise Intervention
Quality-of-Life Assessment
Questionnaire Administration
Telephone-Based Intervention
Text Message
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver focused on measuring Lung cancer, geriatric oncology, physical activity, family caregivers, functional status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Supportive care (coaching call, motivational messages)

    Arm 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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Intervention acceptability as reported by participants
    Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach.

    Full Information

    First Posted
    September 9, 2019
    Last Updated
    August 10, 2021
    Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04085081
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding issue
    Study Start Date
    May 15, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    November 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caregiver, Lobectomy Patient, Lung Carcinoid Tumor, Lung Non-Small Cell Carcinoma
    Keywords
    Lung cancer, geriatric oncology, physical activity, family caregivers, functional status

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supportive care (coaching call, motivational messages)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    E-mail
    Other Intervention Name(s)
    Electronic Mail, Email
    Intervention Description
    Receive brief motivational text or email messages
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise Intervention
    Intervention Description
    Receive personalized walking program plus strength exercises
    Intervention Type
    Other
    Intervention Name(s)
    Quality-of-Life Assessment
    Other Intervention Name(s)
    Quality of Life Assessment
    Intervention Description
    Ancillary studies
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telephone-Based Intervention
    Intervention Description
    Receive intervention coaching sessions via telephone
    Intervention Type
    Other
    Intervention Name(s)
    Text Message
    Other Intervention Name(s)
    SMS Text, SMS Text Message, Text
    Intervention Description
    Receive brief motivational text or email messages
    Primary Outcome Measure Information:
    Title
    Enrollment of >= 70% of eligible participants
    Description
    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.
    Time Frame
    Up to 30 days post-hospital discharge
    Title
    >= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists
    Description
    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.
    Time Frame
    Up to 30 days post-hospital discharge
    Title
    Adherence/engagement
    Description
    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.
    Time Frame
    Up to 30 days post-hospital discharge
    Secondary Outcome Measure Information:
    Title
    Intervention acceptability as reported by participants
    Description
    Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach.
    Time Frame
    Up to 30 days post-hospital discharge
    Other Pre-specified Outcome Measures:
    Title
    Patient and family caregiver outcome patterns and trajectories before and after the intervention
    Description
    Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to explore patterns and trajectories over time.
    Time Frame
    Baseline up to 30 days post-hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Virginia Sun
    Organizational Affiliation
    City of Hope Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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