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

Primary Purpose

Adult Liver Carcinoma, Caregiver, Colorectal Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Quality-of-Life Assessment
Survey Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adult Liver Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

-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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (Walking for Recovery from Surgery)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2017
Last Updated
August 14, 2023
Sponsor
City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03267524
Brief Title
Walking for Recovery From Surgery in Improving Quality of Life in Older Adults With Lung or Gastrointestinal Cancer and Their Family Caregivers
Official Title
Walking for Recovery From Surgery: Pilot Study of a Prehabilitation Intervention for Older Adults With Cancer and Their Family Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
November 28, 2024 (Anticipated)
Study Completion Date
November 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Liver Carcinoma, Caregiver, Colorectal Carcinoma, Lung Carcinoma, Malignant Digestive System Neoplasm, Pancreatic Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (Walking for Recovery from Surgery)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Receive Walking for Recovery from Surgery prehabilitation intervention
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Pedometer-assessed daily steps (patients)
Description
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.
Time Frame
Up to 2 months
Title
6-minute walking time (patients)
Description
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.
Time Frame
Up to 2 months
Title
Timed-up and go (patients)
Description
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.
Time Frame
Up to 2 months
Title
Short Physical Performance Battery (patients)
Description
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.
Time Frame
Up to 2 months
Title
General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (patients)
Description
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.
Time Frame
Up to 2 months
Title
Symptoms (patients)
Description
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.
Time Frame
Up to 2 months
Title
Distress level assessed using Distress Thermometer (patients)
Description
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.
Time Frame
Up to 2 months
Title
Self-efficacy (caregivers)
Description
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.
Time Frame
Up to 2 months
Title
Distress assessed using Distress thermometer (caregivers)
Description
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.
Time Frame
Up to 2 months
Title
General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (caregivers)
Description
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.
Time Frame
Up to 2 months
Title
Functional status (caregivers)
Description
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.
Time Frame
Up to 2 months
Title
Geriatric assessment
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Sun, RN, PhD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31845007
Citation
Lafaro KJ, Raz DJ, Kim JY, Hite S, Ruel N, Varatkar G, Erhunmwunsee L, Melstrom L, Lee B, Singh G, Fong Y, Sun V. Pilot study of a telehealth perioperative physical activity intervention for older adults with cancer and their caregivers. Support Care Cancer. 2020 Aug;28(8):3867-3876. doi: 10.1007/s00520-019-05230-0. Epub 2019 Dec 16.
Results Reference
derived

Learn more about this trial

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

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