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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support women who have completed their initial treatment for ovarian cancer and are transitioning into the survivorship phase. It tests an intervention called the POSTCare Survivorship transition process, designed to improve quality of life by offering additional support compared to usual care. Participants will be randomly assigned to either receive this new support method or continue with standard care. Women with stage 2-4 ovarian cancer who have finished initial treatments like surgery or chemotherapy in the last six months and are not in hospice care are a good fit for this trial. As an unphased trial, this study provides a unique opportunity to enhance the survivorship experience with innovative support.

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 prior data suggests that the POSTCare Survivorship transition process is safe?

Research shows no specific safety information for the POSTCare Survivorship transition process. However, this program aims to help ovarian cancer survivors enhance their quality of life as they transition into survivorship. It assists patients in managing symptoms, monitoring their health, and adopting healthy habits. Although detailed safety data is not available, this program is part of palliative care, which is generally well-tolerated and suitable for patients with serious illnesses like ovarian cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the POSTCare Survivorship transition process because it aims to enhance the quality of life for ovarian cancer survivors by focusing on their long-term health and well-being. Unlike the standard options that often prioritize the immediate treatment of cancer itself, this approach emphasizes a comprehensive care transition, helping patients navigate life after treatment. This method could potentially empower survivors with better resources and support, leading to improved health outcomes and a more personalized care experience.

What evidence suggests that the POSTCare Survivorship transition process is effective for improving quality of life in ovarian cancer survivors?

Research has shown that the POSTCare survivorship transition process can improve the quality of life for cancer survivors, particularly breast cancer patients. In this trial, participants in the intervention group will receive care through the POSTCare process, which provides extra support after main cancer treatments conclude, aiming to reduce stress and enhance well-being. Although researchers have not specifically studied it for ovarian cancer, the process uses telehealth to offer support, potentially benefiting those at high risk of cancer recurrence. Early signs suggest it could help manage the challenges faced during the transition to life after cancer treatment. ^{1 3 5 6 7}

Who Is on the Research Team?

Elizabeth Kvale, MD,MPH

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e17583

POSTCare-O: A survivorship care transition for women with ... The POSTCare survivorship care transition is efficacious as a quality-of-life intervention for patients diagnosed with breast cancer but has not been studied ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10891493/

Survivorship Care for Women Living With Ovarian Cancer We will enroll 120 survivors of ovarian cancer in a randomized controlled trial and collect data at 12 and 24 weeks.

3. withpower.com withpower.com/trial/phase-3-ovarian-neoplasms-3-2023-ac7f1

Survivorship Care for Ovarian Cancer (POSTCARE-O 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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05752448?tab=results

No Study Results Posted | NCT05752448 | Survivorship Care for ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06701

Survivorship Care Planning (POSTcare-O) to Support ... The experience of cancer survivors transitioning from active treatment to survivorship is marked by uncertainty. Patients often experience anxiety and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05752448/survivorship-care-for-women-living-with-ovarian-cancer-postcare-o

Survivorship Care for Women Living With Ovarian Cancer Ovarian cancer survivors (120) will be randomly allocated to receive survivorship care either using the POSTCare Process or standard of care.

7. asco.org asco.org/abstracts-presentations/ABSTRACT365614

A survivorship care transition for women with ovarian cancer. Conclusions: POSTCare intervention can serve as a platform for delivery of components of early concurrent palliative care that is acceptable to ovarian cancer ...