Exercise in All ChemoTherapy

NCT03461471 | Completed

• 1 other identifier: STUDY00005664
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise in all Chemotherapy (EnACT) is a study to assess safety, feasibility, and acceptability of an exercise program within chemotherapy. This will be a single group study to capture the effects of an exercise intervention on the average chemotherapy patient and the patients compliance to the study.

Conditions

Chemotherapy; Exercise

Outcome Measures

Primary Outcomes (1)

• Assess Feasibility

  Feasibility will be obtained if one third of chemotherapy patients actually do the exercise prescribed (one exercise session per week for four weeks).

  Feasibility will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).

Secondary Outcomes (4)

• Compare changes in pain, physical function, nausea, vomiting, arthralgias, chemotherapy alterations (dose delays and alterations).

  Surveys will be given once the patient is consented and again at the completion of the study for each patient (average of 5 months per patient).

• Qualitative assessments of clinician perspectives regarding the study. At the end of the study clinicians will be asked a series of qualitative questions to gain their insight into the study.

  Surveys will be provided to clinicians at the completion of the study (up to 38 months)

• Assessing safety through number of patients with injuries related to the intervention

  A standardized survey for assessing injuries will be used and administered at the end of the patients chemotherapy (average of 5 months)..

• Assess Acceptability

  Acceptability will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).

Study Arms (1)

Intervention Group

EXPERIMENTAL

Exercise intervention

Behavioral: Exercise Intervention

Interventions

Exercise Intervention BEHAVIORAL

Exercise intervention

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years of age
• Fluent in written and spoken English
• Must be able to provide and understand informed consent
• Must have an ECOG PS of ≤ 2
• Diagnosed with a solid tumor malignancy
• Cancer patients (stage 1-4)
• Scheduled to receive chemotherapy at Penn State Cancer Institute
• Absence of absolute contraindications for exercise according to the American Heart Association
• Primary attending oncologist approval

You may not qualify if:

• Receiving chemotherapy at a location other than Penn State Cancer Institute
• Not fluent in written and spoken English
• Hematological malignancy
• Evidence in the medical record of an absolute contraindication for exercise
• Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
• History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of chemotherapy
• Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for \>1 month prior to start of chemotherapy may be eligible
• syncope
• acute myocarditis, pericarditis, or endocarditis
• acute pulmonary embolus or pulmonary infarction
• thrombosis of lower extremities
• suspected dissecting aneurysm
• pulmonary edema
• respiratory failure
• acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kathryn Schmitz, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Public Health Science

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: March 12, 2018
• Study Start: April 1, 2017
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

US (1)