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

Sponsor

City of Hope Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03267524

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Liver Carcinoma Caregiver Colorectal Carcinoma Lung Carcinoma Malignant Digestive System Neoplasm Pancreatic Carcinoma	Behavioral: Exercise Intervention Other: Quality-of-Life Assessment Other: Survey Administration	N/A

Detailed Description

PRIMARY OBJECTIVES:

To examine whether the intervention and telehealth approach would be feasible and acceptable.

SECONDARY OBJECTIVES:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 9, 2017

Anticipated Primary Completion Date :

Nov 9, 2023

Anticipated Study Completion Date :

Nov 9, 2023

Arms and Interventions

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

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

Receive Walking for Recovery from Surgery prehabilitation intervention

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Survey Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

Pedometer-assessed daily steps (patients) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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) [Up to 2 months]
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 [Up to 2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

-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