Survivorship Care Plan for Prostate Cancer

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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Tailored Survivorship Care Plan, Survivorship Care Plan, SCP for prostate cancer?

Survivorship care plans (SCPs) are designed to help cancer survivors manage their health after treatment by providing a summary of their treatment and a follow-up care plan. While there is limited research specifically on SCPs for prostate cancer, studies on SCPs for other cancers suggest they can improve communication and coordination of care between patients and healthcare providers. ^{1 2 3 4 5}

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

Survivorship care plans (SCPs) are designed to help cancer survivors manage their health after treatment by providing a summary of their treatment and a follow-up care plan. While the use of SCPs is recommended and has been studied in various cancers, including breast and colorectal cancer, the research on their effectiveness is limited and not specific to prostate cancer. ^{1 2 3 4 5}

Is the Survivorship Care Plan safe for humans?

The available research on Survivorship Care Plans (SCPs) does not specifically address safety concerns, as SCPs are primarily documents used to guide follow-up care and improve communication between healthcare providers and patients. ^{1 4 5 6 7}

Is the Survivorship Care Plan safe for humans?

The available research on Survivorship Care Plans (SCPs) does not specifically address safety concerns, as SCPs are primarily documents designed to improve communication and care coordination for cancer survivors. ^{1 4 5 6 7}

How is the Survivorship Care Plan treatment different from other prostate cancer treatments?

The Survivorship Care Plan (SCP) is unique because it focuses on helping prostate cancer survivors transition from active treatment to follow-up care, improving communication between patients and their healthcare providers, and ensuring continuity of care, rather than directly treating the cancer itself. ^{4 5 6 7 8}

How is the Survivorship Care Plan treatment for prostate cancer different from other treatments?

The Survivorship Care Plan (SCP) is unique because it focuses on providing a personalized follow-up care plan for prostate cancer survivors, helping them transition from active treatment to ongoing health management. Unlike traditional treatments that target the cancer itself, SCPs aim to improve communication and coordination between patients, oncologists, and primary care providers, ensuring that survivors receive comprehensive care tailored to their individual needs. ^{4 5 6 7 8}

What is the purpose of this trial?

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 in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to a limited number of places in the body (oligometastatic). SCPs summarize treatment history and recommendations for monitoring and maintaining health, and may also include potential long term effects of treatments received. The intention of a SCP is to help patients participate in their own health care. However, many patients have below basic levels of health literacy, meaning, they have a lower ability to obtain, communicate, process and understand basic health information and services to make health decisions. In fact, poor health literacy has been linked with worse quality of life in prostate cancer survivors. A tailored SCP includes the addition of an educational supplement based on lower reading and writing skills (low literacy) and may address health literacy barriers to understanding of treatment options and side effects. A standard SCP uses a template based on the American Society of Clinical Oncology (ASCO) guidelines for prostate cancer. A tailored SCP with low literacy educational supplements may be more effective compared to a standard SCP in improving understanding and access to survivorship care in black or African American patients with localized or oligometastatic prostate cancer.

Research Team

Viraj Master, MD, PhD, FACS

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

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

The impact of cancer survivorship care plans on patient and health care provider outcomes: a current perspective. [2017]

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

Guidelines for the use of survivorship care plans: a systematic quality appraisal using the AGREE II instrument. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Breast cancer survivorship care plans: what are they covering and how well do they align with national guidelines? [2020]

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

Primary Care Provider Evaluation of Cancer Survivorship Care Plans Developed for Patients in their Practice. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Qualitative evaluation of care plans for Canadian breast and head-and-neck cancer survivors. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. [2020]

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

Evaluating Internal Medicine Residents' Awareness on Cancer Survivorship Care Plan: A Pilot Survey. [2023]

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

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