Clinical trial NCT03306992: Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Secondary Lung Cancer
Keywords: Exercise
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2017-10-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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 approximately 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the change in mobility performance at baseline, 2 months and 6 months
timeFrame: Done at baseline, 2 and 6 months
Secondary outcomes:
measure: Evaluate the change Short Physical Performance Battery (SPPB) score
timeFrame: Done at baseline, 2 and 6 months
measure: Compare results from PROMIS Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
timeFrame: Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
measure: Compare results from FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
timeFrame: Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
measure: Compare results from FACIT-F (Chronic Illness Fatigue Scale) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
timeFrame: Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
measure: Compare results from PSQI (Pittsburgh Sleep Quality Index) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
timeFrame: Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
measure: Compare results from BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
timeFrame: Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References:
citation: Ulrich CM, Himbert C, Boucher K, Wetter DW, Hess R, Kim J, Lundberg K, Ligibel JA, Barnes CA, Rushton B, Marcus R, Finlayson SRG, LaStayo PC, Varghese TK. Precision-Exercise-Prescription in patients with lung cancer undergoing surgery: rationale and design of the PEP study trial. BMJ Open. 2018 Dec 16;8(12):e024672. doi: 10.1136/bmjopen-2018-024672.