Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
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| ClinicalTrials.gov Identifier: NCT03860961 |
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Recruitment Status :
Active, not recruiting
First Posted : March 4, 2019
Last Update Posted : December 14, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Survivor Prostate Adenocarcinoma | Other: Questionnaire Administration Other: Survivorship Care Plan (SCP) Other: Treatment Plan | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 834 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy |
| Actual Study Start Date : | August 2, 2019 |
| Estimated Primary Completion Date : | November 30, 2024 |
| Estimated Study Completion Date : | November 30, 2029 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard Survivorship Care Plan (SCP)
Practices review a SCP with patients and send it to the PCP during the last week of RT.
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Other: Questionnaire Administration
Ancillary studies Other: Survivorship Care Plan (SCP) Given survivorship care plan |
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Experimental: Enhanced Survivorship Care Plan (SCP)
Practices review a treatment plan with patient and send it to the PCP at the beginning of RT. Practices also review a SCP with patients and send it to the PCP during the last week of RT.
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Other: Questionnaire Administration
Ancillary studies Other: Survivorship Care Plan (SCP) Given survivorship care plan Other: Treatment Plan Given treatment plan |
- Proportion of patients who saw a primary care provider (PCP) or cardiologist and had their fasting blood glucose checked [ Time Frame: At 24 months after completion of radiation therapy (RT) ]Will be evaluated on the individual level using an adjusted chi-square test that computes clustering correction factors computed for the treatment (Donner 1989) and tested with a 2-sided type I error of 0.05. A sensitivity analysis will be conducted assuming patients who have missing data at 24 months did not have their glucose checked or see their PCP or cardiologist.
- Proportion of patients who saw a primary care provider (PCP) or cardiologist and had their cholesterol checked [ Time Frame: At 24 months after completion of radiation therapy (RT) ]Will be evaluated on the individual level using an adjusted chi-square test that computes clustering correction factors computed for the treatment (Donner 1989) and tested with a 2-sided type I error of 0.05. A sensitivity analysis will be conducted assuming patients who have missing data at 24 months did not have their cholesterol checked or see their PCP or cardiologist.
- Eligible screened patients with a PCP or cardiologist [ Time Frame: At baseline ]Each National Cancer Institute NCI Community Oncology Research Program (NCORP) practice will screen (step 0) and keep a log of all patients who are eligible, regardless of whether the patient has an existing PCP and/or cardiologist. The percentage of the enrolled patients out of all eligible patients (excluding the PCP requirement) will be provided along with the percentages broken down by practice.
- High health literacy levels [ Time Frame: At baseline ]Will be associated with improved patient-reported coordination of care and satisfaction with care. Will be assessed using BHLS.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PRACTICE ELIGIBILITY CRITERIA
- Practices (defined as a single NCORP component or subcomponent; or NCORP component and/or subcomponents that share the same physicians and/or staff, but are in different locations) will be randomized to receive standard of care (control arm) or increased SCP dose (experimental arm) once all of the eligibility criteria specified below have been met.
- All institutions participating in a practice are NCORP components or sub-components
- Have a mechanism for delivering SCPs to prostate cancer patients. Practices that currently provide SCPs are eligible but for this trial will need to use the study-provided SCP template.
- See at least 10 patients meeting eligibility criteria per year.
- Completion and submission of the NRG-CC007CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit [CTSU] website) by each practice to NRGCC007CD@nrgoncology.org).
- Institutional Review Board (IRB) approval
- Each principal investigator (PI) and research assistant (RA) at a NCORP practice must complete NRG-CC007CD SCP training. A training certificate will need to be completed and uploaded to the CTSU Regulatory Submission Portal. (See NRG-CC007CD Training Memo and Slides; located on the CTSU website).
- Any site participating within a practice that is participating on Wake Forest study, WF-1804CD is not able to participate in this trial in order to not impact the fidelity of either trial.
PATIENT ELIGIBILITY CRITERIA - PRIOR TO REGISTRATION (STEP 1)
- The participant must be able to complete required questionnaires in English
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The participant must have a diagnosis of prostate adenocarcinoma that will be treated with RT plus androgen deprivation therapy (ADT) with curative intent. Both definitive RT (intact prostate) and postprostatectomy RT patients are eligible
- The ADT must be planned for at least 4 months and must include luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist
- ADT may have started for no more than 120 days before registration
- The participant must have a primary care provider and/or cardiologist or plan to obtain one
- Comorbidities assessed at study entry using the Adult Comorbidity Evaluation (ACE)-27 instrument (located on the CTSU website)
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860961
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| Principal Investigator: | Ronald C Chen | NRG Oncology |
| Responsible Party: | NRG Oncology |
| ClinicalTrials.gov Identifier: | NCT03860961 |
| Other Study ID Numbers: |
NRG-CC007CD NCI-2019-00794 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NRG-CC007CD ( Other Identifier: NRG Oncology ) NRG-CC007CD ( Other Identifier: DCP ) NRG-CC007CD ( Other Identifier: CTEP ) UG1CA189867 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 4, 2019 Key Record Dates |
| Last Update Posted: | December 14, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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