Survivorship Care for Ovarian Cancer

(POSTCARE-O Trial)

Recruiting at 2 trial locations

Overseen By Judy Bettencourt, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Hospice admission

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

Compensation: Varies

Number of Visits: 12

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the POSTCare-O process, a telehealth support program for women who have completed initial treatment for Stage 2-4 ovarian cancer. The program offers ongoing support and guidance from healthcare professionals to help manage health and improve quality of life.

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 continued maintenance therapy is okay, so you might be able to stay on some treatments.

What data supports the effectiveness of the POSTCare Survivorship transition process treatment for ovarian cancer?

The POSTCare intervention, which is used for breast cancer survivors, involves a single coaching session that helps patients manage their care after treatment. This approach, based on the Chronic Care Model and using motivational interviewing, has shown positive effects on patient outcomes and care coordination, suggesting it may also benefit ovarian cancer survivors. ^{1 2 3 4 5}

Is the POSTCare Survivorship transition process safe for humans?

The available research does not provide specific safety data for the POSTCare Survivorship transition process, but it focuses on improving patient outcomes and care coordination, suggesting it is designed to support rather than harm participants. ^{1 2 5 6 7}

How is the POSTCare Survivorship transition process treatment different from other treatments for ovarian cancer?

The POSTCare Survivorship transition process is unique because it focuses on helping ovarian cancer survivors transition from specialized cancer care to self-management and primary care. It uses motivational interviewing techniques to engage patients, which is different from traditional treatments that primarily focus on medical interventions. ^{1 2 3 5 6}

Research Team

Elizabeth Kvale, MD,MPH

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for women who have completed initial treatment for stage 2-4 ovarian cancer within the last 6 months. They must have undergone surgery, chemotherapy, biologics, or maintenance therapy and be able to consent in English or Spanish. Women admitted to hospice after ovary cancer treatment cannot participate.

Inclusion Criteria

I can give my consent in English or Spanish.

I have been treated with surgery, drugs, or other therapies for my condition.

I finished my initial cancer treatment less than 6 months ago.

Exclusion Criteria

I will be admitted to hospice after my ovarian cancer treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive survivorship care using the POSTCare-O process or usual care

12 weeks

Telehealth visits

Follow-up

Participants are monitored for quality of life, fear of recurrence, and symptom burden

12 weeks

Assessments at 12 and 24 weeks

Treatment Details

Interventions

• POSTCare Survivorship transition process

Trial Overview The study tests a support process called POSTCare Survivorship transition designed for women post-ovarian cancer treatment. It aims to improve their quality of life during survivorship. Participants will either receive this specialized care or usual care and will be compared over a period of 12 weeks.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

Group received care Using POSTCare process

Group II: Usual Care Active Control 1 Intervention

Group received usual care

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

University of Texas - Austin

Collaborator

Trials

1

Recruited

120+

UT Houston School of Public Health

Collaborator

Trials

1

Recruited

120+

UT Southwest

Collaborator

Trials

1

Recruited

120+

Findings from Research

The POSTCARE intervention, which involves a single coaching session using motivational interviewing techniques, significantly improved self-reported health and reduced social role limitations among 79 breast cancer survivors compared to usual care.

Participants in the POSTCARE group also showed clinically meaningful improvements in quality of life, particularly in physical role, bodily pain, and emotional role, suggesting that this approach enhances care coordination and patient outcomes during the transition from cancer care to self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered support in the survivorship care transition: Outcomes from the Patient-Owned Survivorship Care Plan Intervention. Kvale, EA., Huang, CS., Meneses, KM., et al.[2017]

Current research on ovarian cancer primarily addresses symptoms and concerns during treatment, leaving a significant gap in understanding the long-term survivorship issues faced by women after treatment.

There is a need for further studies focusing on the quality of life and psychosocial challenges of long-term ovarian cancer survivors, especially regarding the physical side effects of aggressive treatments and their impact on daily living.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship issues in ovarian cancer: a review. Lockwood-Rayermann, S.[2022]

A survey of 283 gynecologic oncologists revealed that the most common follow-up practices for ovarian cancer patients included office visits, pelvic exams, and serum CA-125 level tests, while imaging studies were rarely recommended.

There was significant variation in the frequency of follow-up tests among oncologists, and the overall intensity of surveillance decreased over time, highlighting the need for further research to determine the optimal follow-up strategy for ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer patient surveillance after curative-intent initial treatment. Harmandayan, GZ., Gao, F., Mutch, DG., et al.[2022]

A systematic review of follow-up care after primary treatment for endometrial and ovarian cancer found no evidence that such follow-up improves survival rates for patients, indicating a need to rethink its purpose.

Current follow-up methods, which primarily involve gynecologic examinations and ultrasounds, lack the sensitivity and specificity needed to effectively detect recurrences, suggesting that follow-up should focus on other outcomes like quality of life and treatment costs rather than just early detection of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of gynecologic cancer follow-up: evidence-based ignorance? Lajer, H., Jensen, MB., Kilsmark, J., et al.[2019]

A key study indicated that early treatment based on elevated CA125 levels did not improve overall survival compared to waiting for symptoms, suggesting that routine surveillance may not be necessary for asymptomatic women.

The guidance recommends personalized follow-up options for survivors of ovarian cancer, including the choice of no formal follow-up, and emphasizes the importance of educating patients about recurrence symptoms and potential follow-up models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up of patients who are clinically disease-free after primary treatment for fallopian tube, primary peritoneal, or epithelial ovarian cancer: a Program in Evidence-Based Care guideline adaptation. Le, T., Kennedy, EB., Dodge, J., et al.[2019]

The transition from cancer treatment to survivorship is crucial, as patients often face lingering symptoms, physical function issues, and emotional distress immediately after treatment ends.

A post-treatment risk model is proposed to better understand patients' needs, highlighting that while some may require standard care plans, others may need more comprehensive support based on their treatment experiences and emotional health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom management and psychosocial outcomes following cancer. Given, CW., Given, BA.[2015]

The transition from cancer treatment to posttreatment follow-up care is crucial for the long-term health of survivors, and there is a growing emphasis on shifting this responsibility to primary care providers.

Survivorship care plans are essential for supporting this transition, but their adoption has been slow due to various barriers, highlighting the need for further research to identify effective models and best practices for implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition to survivorship: can there be improvement? Fitch, MI.[2019]

References

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

Patient-centered support in the survivorship care transition: Outcomes from the Patient-Owned Survivorship Care Plan Intervention. [2017]

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

Survivorship issues in ovarian cancer: a review. [2022]

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

Ovarian cancer patient surveillance after curative-intent initial treatment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The value of gynecologic cancer follow-up: evidence-based ignorance? [2019]

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

Follow-up of patients who are clinically disease-free after primary treatment for fallopian tube, primary peritoneal, or epithelial ovarian cancer: a Program in Evidence-Based Care guideline adaptation. [2019]

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

Symptom management and psychosocial outcomes following cancer. [2015]

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

Transition to survivorship: can there be improvement? [2019]