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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04085081
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE September 9, 2019
First Posted Date  ICMJE September 11, 2019
Last Update Posted Date January 21, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date July 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • 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.
  • >= 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
Intervention acceptability as reported by participants [ Time Frame: Up to 30 days post-hospital discharge ]
Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2019)
Patient and family caregiver outcome patterns and trajectories before and after the intervention [ Time Frame: Baseline up to 30 days post-hospital discharge ]
Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to explore patterns and trajectories over time.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Caregiver
  • Lobectomy Patient
  • Lung Carcinoid Tumor
  • Lung Non-Small Cell Carcinoma
Intervention  ICMJE
  • Other: E-mail
    Receive brief motivational text or email messages
    Other Names:
    • Electronic Mail
    • Email
  • Behavioral: Exercise Intervention
    Receive personalized walking program plus strength exercises
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Behavioral: Telephone-Based Intervention
    Receive intervention coaching sessions via telephone
  • Other: Text Message
    Receive brief motivational text or email messages
    Other Names:
    • SMS Text
    • SMS Text Message
    • Text
Study Arms  ICMJE Experimental: Supportive care (coaching call, motivational messages)
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.
Interventions:
  • Other: E-mail
  • Behavioral: Exercise Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Behavioral: Telephone-Based Intervention
  • Other: Text Message
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 23, 2021
Estimated Primary Completion Date July 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04085081
Other Study ID Numbers  ICMJE 19252
NCI-2019-05582 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19252 ( Other Identifier: City of Hope Comprehensive Cancer Center )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Virginia Sun City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP