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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2028
  • participants needed
    504
  • sponsor
    NRG Oncology
Updated on 14 October 2020
Investigator
Steven K. Bergstrom
Primary Contact
Kaiser Permanente Oakland-Broadway (9.6 mi away) Contact
+62 other location
diabetes
cancer
androgens
antiandrogen therapy
androgen suppression

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.

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 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.

Details
Treatment questionnaire administration, Treatment plan, Survivorship Care Plan (SCP)
Clinical Study IdentifierNCT03860961
SponsorNRG Oncology
Last Modified on14 October 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Cancer Survivor or Prostate Adenocarcinoma?
PRACTICE ELIGIBILITY CRITERIA
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](mailto: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
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)
Completion and submission of the Brief Health Literacy Screen, Coordination of Care, and Patient Satisfaction with Care within 42 days prior to registration
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet