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

Colorectal Carcinoma Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Adult Liver Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Caregiver
• Colorectal Carcinoma
• Colorectal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Lung Carcinoma
• Malignant Digestive System Neoplasm
• Pancreatic Carcinoma
• Pancreatic Neoplasms

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