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

NCT03267524 | Completed DMC

• 2 other identifiers: 17277NCI-2017-01565
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Liver Carcinoma; Caregiver; Colorectal Carcinoma; Lung Carcinoma; Malignant Digestive System Neoplasm; Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (1)

Supportive Care (Walking for Recovery from Surgery)

EXPERIMENTAL

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; Other: Quality-of-Life Assessment; Other: Survey Administration

Interventions

Exercise Intervention BEHAVIORAL

Receive Walking for Recovery from Surgery prehabilitation intervention

Supportive Care (Walking for Recovery from Surgery)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (Walking for Recovery from Surgery)

Survey Administration OTHER

Ancillary studies

Supportive Care (Walking for Recovery from Surgery)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• 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.

  PMID: 31845007 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Colorectal Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Virginia Sun, RN, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 30, 2017
• Study Start: November 9, 2017
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

US (1)