This trial studies the effect of a home-based exercise program and the combination of the exercise program with a mindfulness based intervention and auricular point acupressure on fatigue, physical function, and protein levels in patients whose cancer is confined to the site in which it initially manifested (non-metastatic). This trial may help provide better care for cancer survivors who are suffering from chronic fatigue in the future.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03576274.
PRIMARY OBJECTIVES:
I. To test the feasibility of a 12-week technology-enhanced home exercise (TEHE) program.
II. To determine the effect of the TEHE program on fatigue, physical activity and serum biomarkers (Heat Shock Protein 90 and Brain-Derived Neurotrophic Factor) compared to the control (usual care) group.
SECONDARY OBJECTIVES:
I. To compare the effect of the combined TEHE program with auricular point acupressure (APA) and mindfulness body intervention (MBI) with the TEHE alone on fatigue and physical activity.
II. To determine the change in serum biomarkers at week 12 compared to baseline in the TEHE alone, APA+TEHE, and MBI+TEHE control (usual care) groups.
III. To explore the associations of muscle and brain energetic markers using magnetic resonance spectroscopy (MRS) with fatigue symptoms of cancer survivors.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients continue daily usual physical activity. Patients may also undergo magnetic resonance spectroscopy (MRS) over 60 minutes.
ARM II: Patients undergo TEHE over 12 weeks. Patients may also undergo MRS over 60 minutes.
ARM III: Patients undergo TEHE over 12 weeks and APA. Patients may also undergo MRS over 60 minutes.
ARM IV: Patients undergo TEHE over 12 weeks and MBI twice daily (BID). Patients may also undergo MRS over 60 minutes.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorNada Lukkahatai