Survivorship Care Coordination for Prostate Cancer

Recruiting at 84 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: NRG Oncology

Must be taking: Androgen deprivation therapy

Disqualifiers: Diabetes, Hypercholesterolemia, Cardiovascular events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

546 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is Survivorship Care Coordination for Prostate Cancer safe for humans?

The research articles do not provide specific safety data for Survivorship Care Coordination or Survivorship Care Planning, but they emphasize the importance of well-designed survivorship programs for improving patient care and outcomes. ^{1 2 3 4 5}

How is Survivorship Care Planning different from other treatments for prostate cancer?

Survivorship Care Planning is unique because it focuses on coordinating care after prostate cancer treatment, addressing health promotion, managing physical and emotional side effects, and ensuring follow-up care aligns with guidelines, rather than directly treating the cancer itself. ^{3 4 5 6 7}

What data supports the effectiveness of the treatment Survivorship Care Planning for prostate cancer?

Research shows that integrated care models and shared care approaches, which are part of survivorship care planning, can effectively address the health and psychosocial needs of prostate cancer survivors, improving their overall care experience. ^{5 6 8 9 10}

Who Is on the Research Team?

Ronald C Chen

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for prostate cancer survivors who are undergoing radiation and androgen deprivation therapy. They must be able to fill out questionnaires in English, have a primary care provider or cardiologist, and consent to the study. Practices need IRB approval, complete specific training, and follow certain protocols. Patients already on ADT for no more than 120 days may join.

Inclusion Criteria

I am scheduled for hormone therapy for my cancer for at least 4 months.

All institutions participating in a practice are NCORP components or sub-components

I can complete questionnaires in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy (RT)

Participants receive radiation therapy and survivorship care planning is reviewed

6-8 weeks

Weekly visits during RT

Follow-up

Participants are monitored for safety and effectiveness after treatment, including coordination with PCP and cardiologist

24 months

Periodic follow-up visits

Enhanced Survivorship Care Planning

Enhanced SCP is reviewed and sent to PCP at the beginning of RT

Concurrent with RT

What Are the Treatments Tested in This Trial?

Interventions

• Survivorship Care Planning

Trial Overview The trial tests if increasing survivorship care planning can improve outcomes for prostate cancer survivors on therapy that raises risks of diabetes and heart issues. It compares standard care with an increased dose of coordinated survivorship care between oncologists and primary caregivers.

How Is the Trial Designed?

Group I: Arm B (enhanced SCP) Experimental Treatment 3 Interventions

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.

Group II: Arm A (standard) Active Control 2 Interventions

Practices review a SCP with patients and send it to the PCP during the last week of RT.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The integrated multicomponent survivorship care model for men with prostate cancer was feasible, with a participation rate of 49% among eligible men and 42% among nominated carers, indicating good engagement with the program.

The program was successfully implemented without any adverse events, demonstrating that it can effectively provide support through various components like exercise, nutrition management, and clinical support for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated multicomponent care model for men affected by prostate cancer: A feasibility study of TrueNTH Australia. Yates, P., Carter, R., Cockerell, R., et al.[2021]

A study involving 88 men with low- to moderate-risk prostate cancer showed that a shared care model, which included more primary care visits and a survivorship care plan, produced similar psychological and quality of life outcomes compared to usual hospital care.

Men in the shared care group preferred this model over traditional hospital follow-ups (63% vs 24%), and it was also more cost-effective, saving approximately AUS$323 per patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer. Emery, JD., Jefford, M., King, M., et al.[2022]

The analysis of 119 prostate cancer survivorship care plans revealed that while most plans included essential treatment details and monitoring recommendations, none specified the annual digital rectal exam (DRE) that all guidelines recommend, indicating a gap in critical follow-up care.

Although 90% of plans were guideline-concordant for PSA testing in the first 5 years, there were significant deficiencies in recommending necessary tests for men on androgen deprivation therapy (ADT), with only 1% advised to have bone density imaging and 16% for testosterone level testing, highlighting the need for improved care plan quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are survivorship care plans failing to tell men after prostate cancer treatment? Choi, Y., Smith, KC., Shukla, A., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

An integrated multicomponent care model for men affected by prostate cancer: A feasibility study of TrueNTH Australia. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Interventions for prostate cancer survivorship: A systematic review of reviews. [2022]

3. England pubmed.ncbi.nlm.nih.gov

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

The role of routine follow-up visits of prostate cancer survivors in addressing supportive care and information needs: a qualitative observational study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Quality of early prostate cancer follow-up care from the patients' perspective. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Contemporary consumer perspectives on prostate cancer survivorship: Fifty voices. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Improving research for prostate cancer survivorship: A statement from the Survivorship Research in Prostate Cancer (SuRECaP) working group. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer survivorship: Implementation of survivorship care plans to meet the mandate and enhance urologic practice through collaborative care. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

What are survivorship care plans failing to tell men after prostate cancer treatment? [2021]

10. England pubmed.ncbi.nlm.nih.gov

Association between perception of care coordination and health outcomes in Korean cancer survivors. [2020]