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Tailored Exercise Program for Cancer Patients (PALS Trial)
N/A
Recruiting
Led By William Hundley, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 3 months and 6 months after study intervention
Awards & highlights
PALS Trial Summary
This trial will test if physical activity/educational classes help preserve exercise, heart function, brain activities & quality of life for cancer patients.
Who is the study for?
This trial is for adults aged 18-85 with Hodgkin's or non-Hodgkin's lymphoma who can walk two city blocks and are expected to undergo certain cancer therapies. They must speak English, have a survival expectancy beyond 6 months, and an assistant for home-based activities. Exclusions include uncontrolled high blood pressure, MRI contraindications, recent heart attack, inability to exercise on treadmill/cycle, pregnancy, drug abuse history, inflammatory conditions or other safety-compromising medical issues.Check my eligibility
What is being tested?
The study compares the effects of a physical activity program using Trainerize app and educational workshops on preserving exercise capacity during cancer treatment. Participants will be randomly assigned to either attend health workshops focusing on lifestyle education or engage in moderate physical activities remotely or in person throughout their treatment.See study design
What are the potential side effects?
Potential side effects from participating may include muscle soreness from exercise; stress due to time commitment; discomfort from wearing fitness tracking devices; possible anxiety related to health monitoring through questionnaires and tests like MRI scans and blood draws.
PALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 3 months and 6 months after study intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 3 months and 6 months after study intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Peak VO2
Secondary outcome measures
Change in 6-Minute Walk Distance
Change in Calculated A-V Oxygen Levels
Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)
+12 morePALS Trial Design
2Treatment groups
Experimental Treatment
Group I: Physical Activity InterventionExperimental Treatment6 Interventions
Participants will have the ability to attend one to two training sessions per week and 1-2 sessions per week at home (the 4th level of our multi-level intervention) or the location site using the Trainerize application to deliver the exercise prescription.
Group II: Healthy Living Intervention (Control Arm)Experimental Treatment5 Interventions
Participants randomized to the control arm will participate in organized health workshops. Each session will last 60 minutes and will be offered on location and virtually (e.g., Zoom) over 6 months. Participants will meet once a week for the first 4 weeks, biweekly for 3 months, and once a month for the last 2 months for a total of 12 sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI scan
2022
Completed Phase 4
~2690
Quality of Life Questionnaires
2005
Completed Phase 4
~1380
Cardiopulmonary exercise testing
2012
N/A
~1000
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,805 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,167 Total Patients Enrolled
William Hundley, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have atrial fibrillation with a fast heart rate that isn't well-controlled.I can walk at least 2 city blocks without assistance.I have unstable chest pain.I have been diagnosed with Hodgkin's or non-Hodgkin's lymphoma at any stage.I have not had a heart attack in the last 28 days.I am between 18 and 85 years old.I have someone to help me with home-based tests.I am expected to receive a type of chemotherapy or therapy that could affect my heart.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Activity Intervention
- Group 2: Healthy Living Intervention (Control Arm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently enrolling volunteers?
"Clinicaltrials.gov data demonstrates that this particular study is no longer seeking candidates, having been initially posted on January 1st 2023 and last updated on November 18th 2022. Nevertheless, there are 2103 other trials currently enrolling patients."
Answered by AI
Are there age requirements for enrolment in this research project?
"To be considered eligible for this medical experiment, applicants must meet the age bracket of 18 to 85. Notably, there are 355 trials available for minors and 1,820 studies designated for those over 65 years old."
Answered by AI
Are there any restrictions on participants for this experimental protocol?
"This clinical trial is seeking 66 participants, aged 18 to 85 years old with a confirmed diagnosis of NHL. In addition to the age and health criteria, potential patients must possess fluency in English; demonstrate capability to walk 200 metres on flat terrain; be expected to survive beyond 6 months from enrollment date; and anticipate undergoing an anthracycline-based chemotherapeutic regimen or other potentially cardiotoxic cancer treatments like immune checkpoint inhibitors (ICI's), chemotherapy regimens (anthracyclines/trastuzumab) or radiation within 8 weeks."
Answered by AI
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