NCT03860961

Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well increasing the dose of survivorship care planning improves care and outcomes in prostate cancer survivors receiving radiation therapy and androgen deprivation therapy. There is a need for coordinated care between the cancer care team with the primary care team. This is especially important for prostate cancer survivors who need routine cancer care follow-up with their radiation oncologist and also coordinated routine follow-up with their primary care provider (PCP). This is important because androgen deprivation therapy increases a patient's risk for developing diabetes, hypercholesterolemia, and cardiovascular events. Increasing the dose of survivorship may improve care and outcomes of cancer survivors than standard practices.

Detailed description

PRIMARY OBJECTIVE: 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 OBJECTIVE: 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. Practices are randomized to 1 of 2 arms. After completion of study, patients are followed up periodically.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Survivorship Care Plan	Given survivorship care plan
OTHER	Treatment Plan	Given treatment plan

Timeline

• Start date: 2019-07-26
• Primary completion: 2024-11-14
• Completion: 2025-09-04
• First posted: 2019-03-04
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

79 sites across 1 country: United States