Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
80

Summary

Conditions
Plasma Cell Myeloma
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To assess the feasibility of a 6 month, twice weekly supervised strength training intervention in patients with multiple myeloma. (Cohort 1) II. To assess the feasibility of a 6 month behavioral intervention to prompt an increase in weekly physical activity in patient with mul...

PRIMARY OBJECTIVES: I. To assess the feasibility of a 6 month, twice weekly supervised strength training intervention in patients with multiple myeloma. (Cohort 1) II. To assess the feasibility of a 6 month behavioral intervention to prompt an increase in weekly physical activity in patient with multiple myeloma. (Cohort 2) SECONDARY OBJECTIVES: I. To assess the adherence rate of patients during a 6 month intervention program. II. To assess the eligibility and recruitment rate for the trial among patients with multiple myeloma. EXPLORATORY OBJECTIVES: I. Comparison of disease activity parameters, physical activity level, clinical symptoms, medication, psycho-oncological parameters before, during and after intervention. II. Determine factors that may influence a persons' willingness to participate in the trial. III. Investigate "immune fitness" by frequencies and function of immune cell subsets in peripheral blood. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHRT 1 (STRENGTH TRAINING): Patients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour twice weekly (BID) up to 52 sessions for 6 months. COHORT 2 (BEHAVIORAL INTERVENTION): Patients receive a Fitbit to track their physical activity, and complete an unsupervised walking program daily at home, increasing physical activity stepwise weekly, for 6 months. After completion of study, patients are followed up every 3 months for 1 year.

Tracking Information

NCT #
NCT03793907
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jens Hillengass Roswell Park Cancer Institute