Colorectal Carcinoma Clinical Trial
Official title:
Walking for Recovery From Surgery: Pilot Study of a Prehabilitation Intervention for Older Adults With Cancer and Their Family Caregivers
Verified date | August 2023 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | November 28, 2024 |
Est. primary completion date | November 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | -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 |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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