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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03267524
Other study ID # 17277
Secondary ID NCI-2017-01565
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 9, 2017
Est. completion date November 28, 2024

Study information

Verified date August 2023
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot clinical trial studies how well Walking for Recovery from Surgery works in improving quality of life in older adults with lung or gastrointestinal cancer and their family caregivers. A walking program, such as Walking for Recovery from Surgery may help support overall well-being as a caregiver, and may help improve family member or friend's recovery from surgery.


Description:

PRIMARY OBJECTIVES: I. To examine whether the intervention and telehealth approach would be feasible and acceptable. SECONDARY OBJECTIVES: I. To examine patient outcome patterns suggesting the potential efficacy of the intervention on self-efficacy, functional status (daily steps, 6-minute walk time, timed up and go), psychological distress, symptoms, and global health status. OUTLINE: Patients and caregivers receive Walking for Recovery from Surgery prehabilitation intervention in 4 sessions 3-7 days before surgery, before discharge, and at 2 and 7 days post-discharge. After completion of study, patients and caregivers are followed up for 2 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date November 28, 2024
Est. primary completion date November 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility -Inclusion: - PATIENT: Diagnosis of lung or GI (colorectal, pancreas, liver) cancers - PATIENT: Scheduled to undergo surgery - PATIENT: >= 65 years - PATIENT: Able to read and understand English - CAREGIVER: Family member/friend identified by the patient as the primary caregiver before and after surgery - CAREGIVER: >= 21 years - CAREGIVER: Able to read and understand English - This study will be conducted in patients and family caregivers who are scheduled to undergo lung or GI cancer surgery treatment - There are no restrictions related to performance status or life expectancy - All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Study Design


Intervention

Behavioral:
Exercise Intervention
Receive Walking for Recovery from Surgery prehabilitation intervention
Other:
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies

Locations

Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (1)

Lead Sponsor Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pedometer-assessed daily steps (patients) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary 6-minute walking time (patients) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Timed-up and go (patients) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Short Physical Performance Battery (patients) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (patients) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Symptoms (patients) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Distress level assessed using Distress Thermometer (patients) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Self-efficacy (caregivers) Will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy-Short Form. Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Distress assessed using Distress thermometer (caregivers) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (caregivers) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Functional status (caregivers) Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
Primary Geriatric assessment Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes. Up to 2 months
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