Survivorship Care for Breast Cancer Survivors

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for breast cancer survivors by helping them manage stress and enhance their well-being. It tests a "survivorship care plan," which includes a booklet and, for some, counseling sessions. Participants will receive either the booklet with counseling or just the booklet. This trial suits those in Southern California who have completed breast cancer surgery and treatment and are in the early stages of recovery. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance recovery experiences for future survivors.

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 prior data suggests that survivorship care planning is safe for breast cancer survivors?

Research has shown that survivorship care planning is generally safe for breast cancer survivors. These plans help survivors understand their past treatments and future care, and patients from various backgrounds find them helpful. No harmful side effects have been reported.

Counseling is also considered safe and can enhance well-being. Studies indicate that peer support can boost resilience in breast cancer patients. Although one review found the effects on anxiety and depression to be small, the intervention remained beneficial. Overall, both survivorship care planning and counseling are safe ways to support breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the survivorship care planning being tested for breast cancer survivors because it offers a structured approach to post-treatment care, which is not typically emphasized in standard follow-up care. Unlike the usual check-ups and monitoring, this method involves personalized survivorship care plans (SCP-BCS) and dedicated counseling sessions with a patient navigator. This approach not only helps survivors manage their health better but also addresses emotional and psychological needs, potentially improving overall quality of life in a way that standard medical follow-ups alone may not.

What evidence suggests that this trial's treatments could be effective for improving the quality of life in breast cancer survivors?

This trial will compare different approaches to survivorship care for breast cancer survivors. Research has shown that planning for life after cancer treatment, particularly with counseling, can benefit breast cancer survivors. Participants in this trial may receive counseling sessions with a patient navigator, which studies indicate can greatly improve quality of life and confidence. This approach also helps reduce feelings of depression and anxiety in cancer patients. Specifically, group therapy for women with breast cancer has boosted emotional well-being and overall quality of life. Planning for life after cancer treatment might lower stress and enhance well-being, making it a promising option for those seeking to improve their quality of life after cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Kimlin Ashing-Giwa

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10374798/

How effective is peer-to-peer support in cancer patients ... Most common outcomes were distress, depressive symptoms, anxiety, and quality of life (QoL). Overall, we found only small effects of PTP support on depression/ ...

2. ojrd.biomedcentral.com ojrd.biomedcentral.com/articles/10.1186/s13023-024-03477-3

A systematic review of peer support interventions to improve ... This study aimed to (1) summarise research on the impact of peer support interventions aimed at improving psychosocial functioning among cancer survivors.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399122003068

Peer support interventions on quality of life, depression ... Peer support has significant effects on improving QOL and self-efficacy as well as alleviating depression and anxiety among patients with cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6517697/

Effectiveness of therapy group in women with localized ... The aim of this study is to analyze group therapy effectiveness in emotional state and quality of life in women with breast cancer after finalized medical ...

5. link.springer.com link.springer.com/article/10.1007/s12609-024-00559-w

Psychological Intervention and Breast Cancer Examples of the outcomes of psychological intervention in this group are higher survival rates at ten-year follow-up, decreased depressive ...

6. iaap-journals.onlinelibrary.wiley.com iaap-journals.onlinelibrary.wiley.com/doi/full/10.1111/aphw.12473

What works in peer support for breast cancer survivors: A ... The aim of the present systematic review and meta-ethnography is to explore the qualitative evidence on the experience of breast cancer survivors in peer ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388924001145

A randomized controlled trial of the effectiveness of a one- ... Peer support increases resilience in breast cancer patients with chemotherapy. •. In the control group without chemotherapy, decreased levels of resiliency.

8. link.springer.com link.springer.com/article/10.1007/s11764-023-01515-w

Professionally led support groups for people living with ... Outcome data included (a) intervention effectiveness and (b) factors affecting implementation. Preliminary review of the studies indicated that ...