Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cancer Survivor
- Prostate Adenocarcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To determine if the experimental arm (increased doses of survivorship care planning [SCP]) has more patients who saw a primary care provider and had blood glucose and cholesterol checked in year 2 (13-24 months) after finishing radiation therapy (RT) as compared to the control...
PRIMARY OBJECTIVES: I. To determine if the experimental arm (increased doses of survivorship care planning [SCP]) has more patients who saw a primary care provider and had blood glucose and cholesterol checked in year 2 (13-24 months) after finishing radiation therapy (RT) as compared to the control arm. SECONDARY OBJECTIVES: I. To determine if patients who receive increased doses of SCP have lower cardiovascular disease (CVD) risk score at 2 years as compared to patients who receive a one-time SCP. II. To determine if patients who receive increased doses of SCP have improved patient reported coordination and satisfaction with care with respect to their primary care provider (PCP) or cardiologist as compared to patients who receive a one-time SCP and whether health literacy modifies the effect of SCP use on patient-reported coordination of care and satisfaction with care with respect to their PCP or cardiologist. III. To determine the number of patients eligible, but without a PCP/cardiologist. IV. To describe the current practice related to SCP delivery and prostate cancer survivor monitoring in participating National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practices. EXPLORATORY OBJECTIVES: I. To determine if patients who receive increased doses of SCP have improved patient reported coordination and satisfaction with care with respect to their cancer specialist as compared to patients who receive a one-time SCP and whether health literacy modifies the effect of SCP use on patient-reported coordination of care and satisfaction with care with respect to their cancer specialist. OUTLINE: Practices are randomized to 1 of 2 arms. ARM A (STANDARD): Practices review a SCP with patients and send it to the PCP during the last week of RT. ARM B (ENHANCED SCP): Practices review a treatment plan with patient and send it to the PCP at the beginning of RT. Practices also review a SCP as arm A. After completion of study, patients are followed up periodically.
Tracking Information
- NCT #
- NCT03860961
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Ronald C Chen NRG Oncology