Clinical trial NCT03267524: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adult Liver Carcinoma
Caregiver
Colorectal Carcinoma
Lung Carcinoma
Malignant Digestive System Neoplasm
Pancreatic Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pedometer-assessed daily steps (patients)
timeFrame: Up to 2 months
measure: 6-minute walking time (patients)
timeFrame: Up to 2 months
measure: Timed-up and go (patients)
timeFrame: Up to 2 months
measure: Short Physical Performance Battery (patients)
timeFrame: Up to 2 months
measure: General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (patients)
timeFrame: Up to 2 months
measure: Symptoms (patients)
timeFrame: Up to 2 months
measure: Distress level assessed using Distress Thermometer (patients)
timeFrame: Up to 2 months
measure: Self-efficacy (caregivers)
timeFrame: Up to 2 months
measure: Distress assessed using Distress thermometer (caregivers)
timeFrame: Up to 2 months
measure: General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (caregivers)
timeFrame: Up to 2 months
measure: Functional status (caregivers)
timeFrame: Up to 2 months
measure: Geriatric assessment
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.