Surveys for Gynecologic Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the experiences of patients with gynecologic cancers and their caregivers over six months. Participants will complete surveys to assess caregiver stress, needs, and patient outcomes. The study includes two groups: one for patients with a caregiver and one for those without, to compare how having a caregiver affects recovery and well-being. Patients receiving chemotherapy for gynecologic cancers who can access the internet or a phone are well-suited for this trial.
As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of caregiving on patient recovery and well-being.
Do I have to stop taking my current medications for the 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, but you should confirm with the study coordinator.
Why are researchers excited about this trial?
Unlike traditional medical treatments for gynecologic cancers, which typically involve surgery, chemotherapy, or radiation, this trial focuses on understanding the impact of caregiver presence through surveys. Researchers are excited because it explores how having a caregiver might influence patient outcomes and caregiver stress, which isn't something standard treatments address. This approach could reveal valuable insights into the emotional and social dimensions of cancer care, potentially leading to more holistic support strategies for patients and their caregivers.
What evidence suggests that this trial's interventions could be effective for gynecologic cancers?
Research has shown that patient-reported outcomes (PROs) serve as useful tools in gynecologic cancer care. These surveys track symptoms, treatment side effects, and overall quality of life for patients with these cancers. In this trial, participants will be divided into two groups: those with caregivers and those without. One study found that electronic PROs effectively monitor patients after major cancer surgeries. Another study showed that these surveys can identify cognitive issues and guide end-of-life care. Overall, PROs offer important insights that can enhance care and outcomes during cancer treatment.12345
Who Is on the Research Team?
Abigail Smith Zamorano, MD
Principal Investigator
UT MD Anderson
Are You a Good Fit for This Trial?
This trial is for people diagnosed with gynecologic cancers and their informal caregivers. Participants must be willing to complete surveys over a 6-month period.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants and caregivers complete baseline assessments to evaluate distress and NMDOH needs
Intervention
Caregivers receive a semi-automated, targeted caregiver resource navigation (CRN) system to address unmet needs
Follow-up
Participants and caregivers complete follow-up assessments at 3 and 6 months to evaluate changes in distress and unmet needs
What Are the Treatments Tested in This Trial?
Interventions
- Surveys
Trial Overview
The study uses surveys to track distress, unmet needs, and outcomes in patients with gynecologic cancers and their caregivers over time. It aims to better understand the challenges faced by both groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
This arm includes participants with gynecologic malignancies who identify and enroll with a caregiver. Both participants and caregivers will complete baseline, 3-month, and 6-month assessments. Caregiver distress and NMDOH needs will be evaluated at baseline, and results will be used to guide the provision of Community Resource Navigation (CRN).
This arm includes patients with gynecologic malignancies who do not identify or enroll with a caregiver. These participants will complete the same assessment timepoints (baseline, 3 months, and 6 months). Data from this group will serve as a comparison to evaluate differences in outcomes relative to patients with caregivers, including the impact of caregiver presence, distress levels, and NMDOH burden.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Ovarian Cancer Research Alliance (OCRA)
Collaborator
Citations
Patient reported outcomes measures in gynecologic oncology
Electronic patient-reported outcomes from home in patients recovering from major gynecologic cancer surgery: A prospective study measuring symptoms and ...
The use of patient-reported outcome tools in Gynecologic ...
Patient-reported outcomes (PRO) are defined as a report of a patient's symptoms, function and general well-being that comes directly from the patient, ...
3.
international-journal-of-gynecological-cancer.com
international-journal-of-gynecological-cancer.com/article/S1048-891X(24)03875-1/fulltextPatient-Reported Outcomes Clinical Trials in Ovarian Cancer
It is now common in ovarian cancer clinical trials for PROs to be used to measure the QoL of patients on different treatment arms as a secondary outcome measure ...
Patient Reported Outcomes for Women Undergoing ...
Purpose: Patients with gynecologic malignancies have high psychosocial and symptom burden. We report data from a prospective trial evaluating patient-reported ...
5.
eprints.whiterose.ac.uk
eprints.whiterose.ac.uk/id/eprint/88845/7/Gynecological_MAIN_TEXT_14.1.2014.pdfPatient-reported outcomes in randomised controlled trials ...
Gynecological cancers arise from the cervix, ovary, endometrium, vulva or vagina and as well as affecting 2.2% of the female population by the ...
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