What side effects are associated with this type of intervention?

The most common treatments for ovarian neoplasms include chemotherapy agents like carboplatin, paclitaxel, and doxorubicin, which are associated with side effects such as neuropathy, cardiotoxicity, fatigue, and cognitive impairment. Immunotherapy with pembrolizumab can lead to immune-related toxicities. The combination of pembrolizumab and lenvatinib has a high rate of toxicity, with common side effects including hypertension, diarrhea, and fatigue.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of ovarian neoplasms, including carboplatin, paclitaxel, and doxorubicin, which are commonly used in chemotherapy regimens. Additionally, bevacizumab, a monoclonal antibody, has been approved for use in combination with chemotherapy for recurrent ovarian cancer. Pembrolizumab, an immune checkpoint inhibitor, is approved for microsatellite-instable solid tumors, including ovarian cancer, and is often used in combination with lenvatinib. These treatments are relevant to the POSTCare-O trial, which aims to improve quality of life for ovarian cancer survivors through structured survivorship care.

What other types of research exist?

Promising alternatives to POSTCare-O for ovarian neoplasms patients include: 1) Integrative survivorship care models that combine medical follow-up with psychosocial support, physical rehabilitation, and nutritional counseling. 2) Digital health interventions, such as mobile apps and telehealth platforms, that provide continuous monitoring and personalized care plans. 3) Enhanced recovery after surgery (ERAS) protocols tailored for ovarian cancer patients to improve postoperative outcomes and quality of life. 4) Immunotherapy and targeted therapy regimens that are being explored for their potential to reduce recurrence and improve long-term survival. 5) Patient-centered care approaches that involve shared decision-making and individualized treatment plans based on genetic and molecular profiling of the tumor.

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Survivorship Care for Ovarian Cancer (POSTCARE-O Trial)

N/A

Recruiting

Led By Elizabeth Kvale, MD,MPH

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Within 6 months of completion of initial treatment (continued maintenance therapy okay)

Stage 2-4 ovarian cancer

Must not have

Admission to hospice at the completion of treatment for ovary cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves supportive care rather than medication, typical drug side effects are not expected. However, participants may experience emotional or psychological responses as they engage with the survivorship transition process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

My ovarian cancer is at stage 2, 3, or 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Depressive Symptom Burden

Quality of Life by FACT-O

Recurrence Fear

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Group received care Using POSTCare process

Group II: Usual CareActive Control1 Intervention

Group received usual care

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian neoplasms include surgery, chemotherapy, and targeted therapies. Surgery aims to remove as much of the tumor as possible, which can reduce tumor burden and improve outcomes. Chemotherapy, often platinum-based, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, such as PARP inhibitors, specifically interfere with cancer cell DNA repair mechanisms, making them particularly effective in patients with BRCA mutations. Understanding these mechanisms is crucial for patients as it helps in anticipating side effects, managing expectations, and improving adherence to treatment plans. Structured survivorship care, like the POSTCare-O process, is essential to address the long-term impacts of these treatments on quality of life, providing support and monitoring to mitigate morbidity and enhance overall well-being.