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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01565 | Registry Identifier | NCI CTRP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Receive Walking for Recovery from Surgery prehabilitation intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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-Inclusion:
Exclusion
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Sun, RN, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31845007 | Derived | 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. |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Survey Administration | Other | Ancillary studies |
|
| 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 |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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