Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT02129569
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT02129569
Study Brief:
Protocol Section:
NCT02129569