- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2017-11-09
2025-03-14
2025-03-14
87
NCT03267524
City of Hope Medical Center
City of Hope Medical Center
INTERVENTIONAL
Walking for Recovery From Surgery in Improving Quality of Life in Older Adults With Lung or Gastrointestinal Cancer and Their Family Caregivers
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-08-29 | N/A | 2025-06-18 |
2017-08-29 | N/A | 2025-06-22 |
2017-08-30 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Supportive Care (Walking for Recovery from Surgery) 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. | BEHAVIORAL: Exercise Intervention
OTHER: Quality-of-Life Assessment
OTHER: Survey Administration
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
