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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

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.

Condition or disease Intervention/treatment Phase
Caregiver Lobectomy Patient Lung Carcinoid Tumor Lung Non-Small Cell Carcinoma Other: E-mail Behavioral: Exercise Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Behavioral: Telephone-Based Intervention Other: Text Message Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Perioperative Physical Activity Intervention for Older Adults With Lung Cancer and Their Family Caregivers
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : July 23, 2021
Estimated Study Completion Date : July 23, 2021


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.

  2. >= 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085081


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Contact: Virginia Sun    626-218-3122    vsun@coh.org   
Principal Investigator: Virginia Sun         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Virginia Sun City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04085081    
Other Study ID Numbers: 19252
NCI-2019-05582 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19252 ( Other Identifier: City of Hope Comprehensive Cancer Center )
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020

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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
Keywords provided by City of Hope Medical Center:
Lung cancer
geriatric oncology
physical activity
family caregivers
functional status
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoid Tumor
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carcinoma, Bronchogenic
Bronchial Neoplasms