Survivorship Care Coordination for Prostate Cancer

No longer recruiting at 88 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for prostate cancer survivors receiving radiation and hormone therapy (a treatment to lower male hormones). The main goal is to determine if a more detailed care plan, known as Survivorship Care Planning, can lead to better health outcomes by coordinating efforts between cancer specialists and primary care doctors. This coordination is crucial because hormone therapy can increase the risk of diabetes and heart problems. Men with prostate cancer who are undergoing radiation and hormone therapy and have a regular doctor might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance care for future prostate cancer survivors.

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.

What prior data suggests that this survivorship care planning is safe for prostate cancer survivors?

Research has shown that survivorship care planning is generally safe for cancer patients. Studies have found that these plans can improve patient health without causing major side effects. A review of several studies found that patients using survivorship care plans had better results than those who did not. Another study suggested that a more personalized version of these plans can further help patients by offering customized programs to improve their health.

The focus here is on helping prostate cancer survivors by organizing their care. This is important because treatments like hormone therapy can increase the risk of diabetes and heart problems. The studies report no serious safety concerns related to survivorship care planning itself, which reassures those considering joining such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Survivorship Care Planning (SCP) for prostate cancer because it could enhance patient care beyond the standard follow-up. Unlike traditional approaches that review care plans at the end of radiation therapy, the enhanced SCP introduces a proactive plan at the beginning, potentially improving communication and coordination with primary care physicians throughout treatment. This approach aims to streamline care, reduce patient anxiety, and improve overall treatment outcomes by keeping all healthcare providers informed and involved from the start.

What evidence suggests that survivorship care planning is effective for prostate cancer survivors?

Research has shown that improved survivorship care plans (ESCP) may help prostate cancer survivors achieve better health outcomes. In this trial, participants in Arm B will receive these enhanced care plans, which focus on the specific needs of each patient, making follow-up care more personalized. One study found that ESCPs, which include a customized program for patients and their partners, can potentially improve health results. While researchers continue to study the overall effectiveness of survivorship care plans, these improved versions show promise for better health management in prostate cancer survivors. ^{2 4 6 7 8}

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

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

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

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 Survivorship Care Plan) Experimental Treatment 2 Interventions

Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.

Group II: Arm A (Survivorship Care Plan) Active Control 1 Intervention

Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7855003/

Enhancing Survivorship Care Planning for Patients with ... Delivering ESCPs that embed a web-link to a couple-focused, tailored program is feasible and can potentially improve patient outcomes.

2. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004359

A Tailored Electronic Survivorship Care Plan for Prostate ... Survivorship care plans (SCPs) aim to enhance patient-centered follow-up, yet their effectiveness remains unclear, especially for PCa survivors.

3. researchprotocols.org researchprotocols.org/2018/2/e51/

Enhancing Survivorship Care Planning for Patients With ... Objective: This study aims to examine the feasibility of an enhanced survivorship care plan (ESCP) that integrates a symptom self-management ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03035773

NCT03035773 | Simplifying Survivorship Care Planning The purpose of this study is to identify an SCP process that is patient-centered, effective in promoting appropriate survivorship care.

5. scholars.uthscsa.edu scholars.uthscsa.edu/en/publications/enhancing-survivorship-care-planning-for-patients-with-localized--2/

Enhancing survivorship care planning for patients with ... Background: This project explores a new model of care that enhances survivorship care planning and promotes health for men with localized prostate cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7011634/

Survivorship Care Plans in Cancer: A Meta‐Analysis and ... Our meta‐analysis compares patient‐reported outcomes between SCP and no SCP (control) conditions for cancer survivors.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767325001284

Long-Term Mortality Trends from Prostate Cancer and ... While advancements in treatment have dramatically improved survival, with 5-year relative survival approaching 98% for localized disease2, ...

8. redjournal.org redjournal.org/article/S0360-3016(25)01673-6/fulltext

Impact of Intensified Survivorship Care Planning on ... Secondary outcomes, including calculated AHA CV risk score and patient-reported outcomes related to coordination of care and satisfaction with cancer care were ...