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Completed

NCT Number: NCT03267524

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

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.

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Key information

Conditions

Adult Liver Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Caregiver Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Malignant Digestive System Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

-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

Treatment and study plan

Exercise Intervention

Behavioral

Receive Walking for Recovery from Surgery prehabilitation intervention

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Pedometer-assessed daily steps (patients)

    Time frame: 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.

  2. 6-minute walking time (patients)

    Time frame: 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.

  3. Timed-up and go (patients)

    Time frame: 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.

  4. Short Physical Performance Battery (patients)

    Time frame: 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.

  5. General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (patients)

    Time frame: 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. Symptoms (patients)

    Time frame: 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.

  7. Distress level assessed using Distress Thermometer (patients)

    Time frame: 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.

  8. Self-efficacy (caregivers)

    Time frame: 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.

  9. Distress assessed using Distress thermometer (caregivers)

    Time frame: 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.

  10. General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (caregivers)

    Time frame: 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.

  11. Functional status (caregivers)

    Time frame: 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.

  12. Geriatric assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2017
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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