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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
No Placebo-Only Group
Summary
This trial tests whether exercise sessions or health workshops can help cancer patients maintain their fitness, heart function, memory, and quality of life during treatment.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Peak VO2
Secondary study objectives
Change in 6-Minute Walk Distance
Change in Calculated A-V Oxygen Levels
Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2710
Cardiopulmonary exercise testing
2012
N/A
~1160
Quality of Life Questionnaires
2005
Completed Phase 4
~1380
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy targets rapidly dividing cancer cells, disrupting their growth and replication.
Radiation therapy uses high-energy rays to destroy cancer cells in specific areas. Immunotherapy boosts the body's immune system to recognize and attack cancer cells.
These treatments are crucial for NHL patients as they directly target and reduce cancerous cells, improving survival rates. Additionally, incorporating physical activity and educational workshops can enhance cardiovascular health, muscle strength, cognitive function, and overall well-being, which are essential for managing side effects and improving quality of life during and after treatment.
The impact of treatment, socio-demographic and clinical characteristics on health-related quality of life among Hodgkin's and non-Hodgkin's lymphoma survivors: a systematic review.
The impact of treatment, socio-demographic and clinical characteristics on health-related quality of life among Hodgkin's and non-Hodgkin's lymphoma survivors: a systematic review.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,901 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,936 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.
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