Walking for Recovery From Surgery in Improving Quality of Life in Older Adults With Lung or Gastrointestinal Cancer and Their Family Caregivers

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Walking for Recovery From Surgery: Pilot Study of a Prehabilitation Intervention for Older Adults With Cancer and Their Family Caregivers

Conditions
-----------------
Adult Liver Carcinoma, Caregiver, Colorectal Carcinoma, Lung Carcinoma, Malignant Digestive System Neoplasm, Pancreatic Carcinoma

Intervention / Treatment
-----------------
* Behavioral: Exercise Intervention
* Other: Quality-of-Life Assessment
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
-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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (Walking for Recovery from Surgery)<br>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<br>* Receive Walking for Recovery from Surgery prehabilitation intervention<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |