Survivorship Care Plan for Prostate Cancer

Not yet recruiting at 2 trial locations

Overseen By Kerry L. Kilbridge, MD, MSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Androgen deprivation

Disqualifiers: Dementia, Recurrent cancer, Second malignancy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized care plan helps Black or African American men with prostate cancer understand and access their follow-up care more effectively than a standard plan. The focus is on those who have completed treatment for localized cancer or cancer that has slightly spread. Participants will receive either a standard care plan or a Tailored Survivorship Care Plan (SCP) with additional educational materials designed for easier understanding. Men who have been disease-free for 1 to 4 years after surgery or radiation, or those on certain ongoing treatments, are ideal candidates for this study. As an unphased trial, this study allows participants to contribute to research that could improve care plans for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients still receiving adjuvant androgen deprivation therapy can participate, suggesting that some medications may be continued.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients still receiving certain prostate cancer treatments may be included, suggesting you might not need to stop all medications.

What prior data suggests that this survivorship care plan is safe for prostate cancer patients?

Research has studied personalized survivorship care plans (SCPs) for prostate cancer patients. These plans aim to help patients better understand their health care. Studies have shown that personalized SCPs do not cause any side effects. They provide patients with clear information about their treatment and health management.

One study found that patients using these plans felt more satisfied with the information they received, suggesting the plans are well-received and safe. The personalized SCPs include easy-to-read educational materials, enhancing patients' understanding of their health.

Overall, personalized SCPs are safe and aim to empower patients by improving their ability to understand health information. No reports of negative effects have emerged from using these plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the way prostate cancer survivors receive ongoing care through tailored Survivorship Care Plans (SCPs). Unlike standard SCPs, which use a one-size-fits-all approach, the tailored SCPs in this trial include personalized information and a low-literacy educational supplement, making them more accessible and relevant for each patient. This approach has the potential to empower patients with a better understanding of their health and improve their long-term quality of life. By comparing tailored SCPs to standard ones, researchers hope to discover whether personalizing care can lead to better outcomes for prostate cancer survivors.

What evidence suggests that a tailored survivorship care plan is effective for improving understanding and access to care in prostate cancer patients?

This trial will compare the effectiveness of different survivorship care plans (SCPs) for prostate cancer survivors. Research has shown that personalized SCPs can assist men who have had prostate cancer by providing custom educational materials that simplify understanding of their health care needs. This is particularly beneficial for those who find medical information challenging to comprehend. While SCPs may work differently for each individual, they aim to address specific challenges, potentially leading to better health outcomes. Although some studies support their use, further research is needed to fully understand their impact on the quality of life for prostate cancer survivors. ^{3 5 6 7 8}

What evidence suggests that a tailored survivorship care plan is effective for improving understanding and access to care in prostate cancer patients?

This trial will compare different approaches to survivorship care plans (SCPs) for prostate cancer. Research has shown that personalized SCPs can help individuals understand and manage their health after prostate cancer treatment. In this trial, participants in Group I will receive a tailored SCP with a low literacy educational supplement, while those in Group II will receive a standard SCP. These plans include easy-to-read materials that assist patients with lower health literacy in understanding their care and treatment options. Early findings suggest that these SCPs can enhance knowledge about treatment side effects and follow-up care. Patients report feeling more confident and involved in their health care when using a personalized SCP. Although more research is needed, these early results are promising for improving care for prostate cancer survivors. ^{3 5 6 7 8}

Who Is on the Research Team?

Viraj Master, MD, PhD, FACS

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for Black or African American patients with prostate cancer that's either localized or has spread to a few other places (oligometastatic). It aims to help those who may struggle with health literacy, which means they find it hard to understand and act on medical information.

Inclusion Criteria

I am a Black or African American man, cancer-free after initial prostate cancer treatment 1-4 years ago.

I am currently on hormone therapy after radiation for my cancer.

Exclusion Criteria

Unable to give informed consent in the judgement of the patient's oncology provider

Individuals who are not able to clearly understand English since the outcome measures require understanding of English

Dementia or cognitive impairment per provider clinical assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes

1 day

1 visit (in-person)

Control

Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for comprehension of survivorship care recommendations and treatment side effects

3 months

Phone call follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Survivorship Care Plan

Trial Overview The study compares two types of survivorship care plans (SCPs): a standard one based on ASCO guidelines and a tailored version designed for easier understanding by people with lower reading skills. The goal is to see if the tailored SCP improves patient comprehension and access to ongoing healthcare.

How Is the Trial Designed?

Group I: Group I (standard SCP, tailored SCP) Experimental Treatment 4 Interventions

Patients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes.

Group II: Group II (standard SCP) Active Control 3 Interventions

Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

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 survey of 39 primary care providers revealed that 90% found survivorship care plans (SCPs) useful, indicating that these plans enhance understanding of cancer treatment and follow-up care.

However, 15% of providers felt unclear about their role in follow-up care, particularly among those in rural areas, suggesting a need for clearer guidelines and additional education on survivor care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Provider Evaluation of Cancer Survivorship Care Plans Developed for Patients in their Practice. Dittus, KL., Sprague, BL., Pace, CM., et al.[2022]

The analysis of 149 breast cancer survivorship care plans (SCPs) revealed that while demographic and treatment information was mostly complete, follow-up recommendations were inconsistent, with significant gaps in post-treatment symptom management and surveillance plans.

Only 15% of women on aromatase inhibitors received guideline-concordant recommendations for bone density testing, highlighting the need for improvements in follow-up care to align with established cancer care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivorship care plans: what are they covering and how well do they align with national guidelines? Choi, Y., Smith, KC., Shukla, A., et al.[2020]

A review of 16 guidelines for survivorship care plans (SCPs) found that none were strongly recommended, indicating a need for improved quality in these guidelines to enhance their use in cancer care.

While the guidelines clearly stated that SCPs should be used, they lacked practical advice on how to implement them effectively, highlighting a gap in addressing barriers and resources needed for successful application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for the use of survivorship care plans: a systematic quality appraisal using the AGREE II instrument. Birken, SA., Ellis, SD., Walker, JS., et al.[2022]

Survivorship care plans (SCPs) were positively received by cancer survivors, nurses, and family physicians, indicating they can enhance communication and ease the transition from active treatment to follow-up care for cancer survivors in western Canada.

Participants noted the individualized nature and comprehensiveness of SCPs as beneficial, but there were concerns about the time needed for implementation, suggesting that streamlining the process could improve their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative evaluation of care plans for Canadian breast and head-and-neck cancer survivors. Collie, K., McCormick, J., Waller, A., et al.[2022]

A study comparing provider-initiated and patient-initiated web-based survivorship care plans (SCPs) found that both approaches faced significant barriers to implementation, with only 33% of providers enrolling and 61% of patients completing follow-up.

Despite the challenges, patients reported high levels of knowledge and confidence regarding their care, indicating that SCPs can be valuable tools for improving communication between patients and healthcare providers, regardless of who initiates the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. Smith, KC., Tolbert, E., Hannum, SM., et al.[2020]

A survey of 37 internal medicine trainees revealed that awareness and utilization of survivorship care plans (SCPs) is very low, with none of the participants using SCPs for cancer-free patients or planning to use them for information.

The majority of trainees (78.3%) reported not being taught about SCPs during their residency, highlighting a significant gap in training that could hinder effective communication and care for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Internal Medicine Residents' Awareness on Cancer Survivorship Care Plan: A Pilot Survey. Riano, I., Pomares-Millan, H., Prasongdee, K., et al.[2023]

Survivorship care plans (SCPs) have not shown significant improvements in patient satisfaction, distress, or quality of life compared to usual care, based on four randomized trials.

However, SCPs did enhance communication between primary care providers and specialists, and a recent trial suggested that focusing on behavioral interventions within SCPs may lead to better self-reported health outcomes and increased self-efficacy among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of cancer survivorship care plans on patient and health care provider outcomes: a current perspective. van de Poll-Franse, LV., Nicolaije, KA., Ezendam, NP.[2017]

Citations

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

A Tailored Electronic Survivorship Care Plan for Prostate ... The objective of this study was to evaluate the effect of a tailored PCa-SCP intervention provided to early-stage PCa survivors.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39705576/

A Tailored Electronic Survivorship Care Plan for Prostate ... The objective of this study was to evaluate the effect of a tailored PCa-SCP intervention provided to early-stage PCa survivors.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03017456

Study Details | NCT03017456 | PC 360 Survivorship A Phase III RCT will evaluate the superiority of a Survivorship Care Plan (SCP) intervention (SCP-Int) compared with usual care (UC) after primary curative ...

4. journals.lww.com journals.lww.com/auajuro/_layouts/15/oaks.journals/downloadpdf.aspx?an=00076734-202504000-00003

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.

5. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00491

General Practitioners' Experiences With Implementing ... In total, 214 GPs participated (response rate, 69%). The overall experience with providing survivorship care was 7.0 ± 1.6 for prostate cancer ...

6. dana-farber.org dana-farber.org/clinical-trials/24-704

Addressing Health Literacy with a Tailored Survivorship ... This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care ...

7. goldjournal.net goldjournal.net/article/S0090-4295(25)00940-9/pdf

Patient-Centered Priorities in Prostate Cancer Survivorship ... Results: Of 362 responders, 259 (71.5%) had surgery and 103 (28.5%) had radiation. Survivors prioritized screening for recurrence and additional ...

8. journals.lww.com journals.lww.com/auajuro/fulltext/2025/04000/a_tailored_electronic_survivorship_care_plan_for.3.aspx

A Tailored Electronic Survivorship Care Plan for Prostate... The primary outcome was change in patient activation (Patient Activation Measure-13); secondary outcomes included satisfaction with information, self-management ...