NCT04085081

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

September 9, 2019

Last Update Submit

August 10, 2021

Conditions

CaregiverLobectomy PatientLung Carcinoid TumorLung Non-Small Cell Carcinoma

Keywords

Lung cancergeriatric oncologyphysical activityfamily caregiversfunctional status

Outcome Measures

Primary Outcomes (3)

  • 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.

    Up to 30 days post-hospital discharge

  • >= 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.

    Up to 30 days post-hospital discharge

  • 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.

    Up to 30 days post-hospital discharge

Secondary Outcomes (1)

  • Intervention acceptability as reported by participants

    Up to 30 days post-hospital discharge

Other Outcomes (1)

  • Patient and family caregiver outcome patterns and trajectories before and after the intervention

    Baseline up to 30 days post-hospital discharge

Study Arms (1)

Supportive care (coaching call, motivational messages)

EXPERIMENTAL

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-mailBehavioral: Exercise InterventionOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationBehavioral: Telephone-Based InterventionOther: Text Message

Interventions

E-mailOTHER

Receive brief motivational text or email messages

Also known as: Electronic Mail, Email
Supportive care (coaching call, motivational messages)
Exercise InterventionBEHAVIORAL

Receive personalized walking program plus strength exercises

Supportive care (coaching call, motivational messages)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Supportive care (coaching call, motivational messages)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (coaching call, motivational messages)
Telephone-Based InterventionBEHAVIORAL

Receive intervention coaching sessions via telephone

Supportive care (coaching call, motivational messages)
Text MessageOTHER

Receive brief motivational text or email messages

Also known as: SMS Text, SMS Text Message, Text
Supportive care (coaching call, motivational messages)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsMotor Activity

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Self-Help DevicesEquipment and Supplies

Study Officials

  • Virginia Sun

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

May 15, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

August 12, 2021

Record last verified: 2021-08