Survivorship Care for Breast Cancer Survivors

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Reside outside Southern California, Kaiser patients, others

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

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

100 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the trial does not exclude participants based on treatments received for conditions like depression, anxiety, hypertension, and diabetes.

What data supports the effectiveness of the treatment Survivorship Care for Breast Cancer Survivors?

Research shows that survivorship care plans (SCPs) help breast cancer survivors by providing important information about their treatment history and follow-up care, which aligns with national guidelines. Additionally, a proactive care pathway can empower patients and improve their quality of life by ensuring they receive comprehensive support after primary treatment. ^{1 2 3 4 5}

Is survivorship care for breast cancer survivors safe?

The research does not provide specific safety data for survivorship care plans, but these plans are generally designed to support ongoing health and wellness after cancer treatment, suggesting they are safe for use in humans. ^{6 7 8 9 10}

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

Survivorship Care Planning is unique because it focuses on creating a personalized plan that includes a summary of past treatments and recommendations for future care, helping survivors manage their health and life after cancer. Unlike other treatments that target the cancer itself, this approach emphasizes self-management, goal setting, and addressing long-term health needs and psychosocial issues. ^{4 11 12 13 14}

What is the purpose of this trial?

This trial tests a special health plan and counseling to help breast cancer survivors manage their health and improve their quality of life. The plan includes a booklet with health tips and support sessions with a healthcare guide.

Research Team

Kimlin Ashing-Giwa

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for breast cancer survivors living in Southern California who are post-surgery up to 18 months after active treatment for stage 0-3 breast cancer. It's open to those with a history of mild depression, anxiety, hypertension, or diabetes.

Inclusion Criteria

You live in Southern California.

You have been treated for stage 0-3 breast cancer within the last 18 months.

BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SCP-BCS template booklet and counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for adherence to SCP guidelines and quality of life improvements

12 months

Follow-up at 6 and 12 months

Treatment Details

Interventions

• Counseling Intervention
• Educational Intervention
• Survivorship Care Planning

Trial Overview The study tests if survivorship care plans can improve life quality for breast cancer survivors. Participants will receive educational and counseling interventions alongside standard care and complete questionnaires assessing their well-being.

Participant Groups

Group I: Arm I (SCP-BCS template booklet and counseling) Experimental Treatment 4 Interventions

Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.

Group II: Arm II (SCP-BCS template booklet) Active Control 4 Interventions

Participants receive SCP-BCS template booklet and receive standard follow-up care.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

The Cancer Treatment Summary and Follow-Up Care Plan is a new model designed to support breast cancer survivors in transitioning from active treatment to ongoing care, addressing complex health issues that may arise post-treatment.

This survivorship care plan promotes better coordination of services and encourages oncology nurses to play a key role in facilitating interdisciplinary collaboration, shifting the focus from acute care to a wellness-oriented approach for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a survivorship care plan for patients with breast cancer. Miller, R.[2022]

The CDC's National Program of Cancer Registries collects comprehensive cancer data on 96% of the U.S. population, which is crucial for understanding cancer incidence, treatment, and outcomes.

Recent advancements in cancer surveillance by the CDC enhance the ability to recruit participants for survivorship research and improve the sharing of treatment summaries, ultimately benefiting cancer survivors and their healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting the Dots: Linking the National Program of Cancer Registries and the Needs of Survivors and Clinicians. Ryerson, AB., Eheman, C., Styles, T., et al.[2019]

The Survivorship Consult (SC) program significantly improved the experience of 26 breast cancer survivors by fostering supportive dialogue with care clinicians, which enhanced their understanding of their health and treatment options.

Participants reported increased confidence in managing their care and were motivated to set personalized health goals, indicating that the SC effectively empowers survivors in their post-diagnosis journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the use of the survivorship consult in providing survivorship care. Wiljer, D., Urowitz, S., Jones, J., et al.[2021]

References

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

Implementing a PROACTive Care Pathway to Empower and Support Survivors of Breast Cancer. [2023]

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

Effectiveness of a Survivorship Program: An Assessment of Patients With Breast Cancer in a Community Setting. [2018]

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

Designing a multifaceted survivorship care plan to meet the information and communication needs of breast cancer patients and their family physicians: results of a qualitative pilot study. [2023]

4. 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]

5. Australia pubmed.ncbi.nlm.nih.gov

Survivorship care after breast cancer: follow-up practices of Australian health professionals and attitudes to a survivorship care plan. [2022]

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

Catalyzing Navigation for Breast Cancer Survivorship (CaNBCS) in Safety-Net Settings: A Mixed Methods Study. [2022]

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

Issues in Breast Cancer Survivorship: Optimal Care, Bone Health, and Lifestyle Modifications. [2018]

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

Implementing a survivorship care plan for patients with breast cancer. [2022]

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

Transitioning to cancer survivorship: plans of care. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Connecting the Dots: Linking the National Program of Cancer Registries and the Needs of Survivors and Clinicians. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

Use and impact of breast cancer survivorship care plans: a systematic review. [2022]

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

Breast Cancer Survivor Symptoms: A Comparison of Physicians' Consultation Records and Nurse-Led Survivorship Care Plans. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

Exploring the use of the survivorship consult in providing survivorship care. [2021]

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

Long term care planning for cancer survivors: a health services research agenda. [2022]