Status:
UNKNOWN
The Vitality Project for Fatigued Female Cancer Survivors
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
Brown University
Conditions:
Fatigue
Cancer Survivorship
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This parallel, randomized, non-inferiority trial will examine whether a ten week qigong intervention is not inferior to a ten week exercise-nutrition comparison group in reducing fatigue in cancer sur...
Detailed Description
The purpose of this study is to examine the therapeutic effects of movement and body awareness on recovery from cancer-related fatigue. In the current study, 60-80 female cancer survivors with cancer-...
Eligibility Criteria
Inclusion
- Female patients
- Aged 18-70 years
- Have completed a course of chemotherapy cancer treatment (except for ongoing treatment with Herceptin \[trastuzumab\] or other adjuvant therapies), AND/OR radiation treatment, AND/OR surgery, with no surgery, radiation or chemotherapy received in the past 8 weeks.
- Endorse a 3/10 or above for the question "On a scale of one to ten, in the last week, how much has your fatigue interfered with your daily life, with 1 being not at all, and 10 being all the time" AND/OR "On a scale of one to ten, in the last week, how much have you felt your sleep has been disturbed or of a quality that you have not felt rested when you wake up, with 1 being not at all, and 10 being all the time"
- Have a primary care or other physician
- Ability to understand English
- Willingness to have blood drawn
- Willingness to have an EEG, EKG, and EMG taken
- Willingness to complete questionnaires
- Willingness and ability to undergo an fMRI scan (screening parameters for this are included below) \[optional: participant doesn't have to do this if it will represent too much burden to the participant, or if they have other contraindications to fMRI such as metal in the body, etc.\]
- Ability to pass basic validated physical movement tests (e.g.: standing with feet touching for 30 seconds, twist right to left and back, hold arms out to side in air for 15 seconds, lift arms over head, moving from standing position to seated position on the floor) to verify safety for qigong and exercise practices
Exclusion
- History or current diagnosis of coronary artery or coronary heart disease
- History or current diagnosis of heart attack, or heart murmur
- Electrical Pacemaker Implant in heart
- Peripheral neuropathy in hands
- History or current diagnosis of any other MAJOR psychiatric disorder (including psychosis, or mania, or suicidal or homicidal ideation) besides depression or anxiety
- Active alcohol or drug abuse
- Tobacco use
- Pregnancy
- Ingestion of caffeine or cocoa products less than two hours from data collection
- Inability to participate in gentle exercises (like pilates)
Key Trial Info
Start Date :
July 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03259438
Start Date
July 24 2017
End Date
January 30 2018
Last Update
August 23 2017
Active Locations (1)
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1
Miriam Hospital Outpatient 146 West River Street
Providence, Rhode Island, United States, 02904