Multiple Myeloma Clinical Trial
Official title:
Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness
This pilot clinical trial studies how well psychoeducational and behavioral strategies work in reducing distress and anxiety in patients with multiple myeloma and their family caregivers. Education and walking programs, may be able to reduce distress and anxiety and improve the well-being and quality of life of patients with multiple myeloma and their family caregivers. Understanding how different forms of education and support can promote emotional wellness may help nurse researchers find ways to improve services provided to patients and family members during cancer treatment.
PRIMARY OBJECTIVES:
I. Evaluate the effect of the intervention, as compared to the control group, on emotional
distress, the primary outcome, measured as anxiety in patients with multiple myeloma and
their caregivers at the transition.
II. Evaluate the effect, including the effect size, of the intervention, as compared to the
control group, on activation for self-management, fatigue, depression, and health-related
quality of life (HRQOL) in both patients and caregivers.
III. Assess the feasibility, acceptability, and content integrity of the intervention in
patients with multiple myeloma and their family caregivers.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants meet with a nurse in-person for approximately 30 minutes to receive
information about strategies for cognitive self-management of distress and an individualized
walking prescription to gradually increase their walking to 30 minutes per day, 5 times per
week. Participants wear a pedometer for at least 3 consecutive days during weeks 1, 6, and
12. Participants are also contacted by the nurse via telephone at 1 and 3 weeks for
supplemental counseling support.
ARM II: Participants meet with a nurse in-person for approximately 20 minutes to receive
National Cancer Institute (NCI) educational booklets and a link to the American Cancer
Society (ACS) website. Participants are also contacted by the nurse via telephone at 1 and 3
weeks but the calls are primarily social in nature and do not include counseling support.
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