Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/21/2018 |
| Start Date: | November 1, 2017 |
| End Date: | October 2022 |
| Contact: | Bailee Rushton |
| Email: | bailee.rushton@hci.utah.edu |
| Phone: | 801-587-4699 |
A Phase III Randomized Study Comparing the Effects of a Personalized Exercise Program (PEP) Against No Intervention in Patients With Stage I-IIIa Primary Non-Small Cell Lung Cancer or Secondary Lung Cancer Undergoing Surgical Resection
This is a Phase 3 study aimed at investigating the effects of a personalized exercise program
(PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing
surgical treatment at the University of Utah and comparing the intervention to the current
standard of care (no exercise program).
(PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing
surgical treatment at the University of Utah and comparing the intervention to the current
standard of care (no exercise program).
This is a Phase 3 study aimed at investigating the effects of a personalized exercise program
(PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing
surgical treatment at the University of Utah and comparing the intervention to the current
standard of care (no exercise program).
Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and
will be followed for 6 months post-surgery:
- An Intervention Arm (referred to in materials as Group 1) which features pre- and
post-surgery PEP interventions.
- A Control Arm (referred to in materials as Group 2) which does not include a
personalized exercise program (the standard of care). Patients randomized to the Control
Arm will be given the opportunity to participate in a PEP-intervention session providing
exercise counseling after the 6 month assessment and will receive a free activity
tracker for their participation.
(PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing
surgical treatment at the University of Utah and comparing the intervention to the current
standard of care (no exercise program).
Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and
will be followed for 6 months post-surgery:
- An Intervention Arm (referred to in materials as Group 1) which features pre- and
post-surgery PEP interventions.
- A Control Arm (referred to in materials as Group 2) which does not include a
personalized exercise program (the standard of care). Patients randomized to the Control
Arm will be given the opportunity to participate in a PEP-intervention session providing
exercise counseling after the 6 month assessment and will receive a free activity
tracker for their participation.
Inclusion Criteria:
- Male or female subject aged ≥ 18 years.
- Diagnosis of primary lung cancer stage I, II, or IIIa OR secondary lung cancer.
- Disease amenable to surgical resection in the opinion of the treating surgeon.
- Patients must be able to follow directions and complete questionnaires and exercise
diaries in English.
- Patients must agree to be randomly assigned to either Intervention or Control Group.
Exclusion Criteria:
- Deemed ineligible for surgery by the enrolling physician
- Abnormalities on screening physical exam judged by study physicians or supervising
physical therapist to contraindicate participation in exercise program compliance.
- Alcohol or drug abuse as judged by study physicians.
- Significant mental or emotional problems that would interfere with study participation
will be assessed by the NCCN Distress Thermometer. Any value higher than 7 will
trigger further intervention, but ultimately enrollment into the clinical trial will
be determined by the enrolling physician.
We found this trial at
1
site
Salt Lake City, Utah 84112
Principal Investigator: Paul LaStayo
Phone: 801-587-4699
Click here to add this to my saved trials
