Frailty for Gynecologic Cancers
(PROOF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how frailty, or increased vulnerability to stressors like illness, impacts recovery and quality of life in adults with newly diagnosed gynecologic cancer. Participants will undergo physical assessments and surveys before and after their standard cancer surgery. Researchers will track their health and treatment progress for up to 10 years to determine how frailty affects outcomes such as survival and chemotherapy schedules. This trial suits adults newly diagnosed with gynecologic cancer who are open to regular check-ins over several years. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could improve future care for gynecologic cancer patients.
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's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this physical function assessment is safe for patients with gynecologic cancer?
Studies have shown that exercise is generally safe for people with gynecologic cancers. Research indicates that staying active can help these patients become stronger and more agile. In the past, many women with gynecologic cancer did not meet exercise recommendations, but those who did experienced benefits. Importantly, no evidence suggests that physical function tests, like those used in this trial, cause harm. These tests simply assess how well someone can move and perform physical activities. Overall, participants tolerate these assessments well, and they have not been linked to any negative effects.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on improving the functional recovery of gynecologic cancer patients with frailty, which is an area often overlooked in standard treatment plans. Unlike traditional approaches that mainly concentrate on treating the cancer itself, this trial emphasizes assessing and enhancing patients' physical function and overall well-being both before and after surgery. By closely monitoring progression-free survival, overall survival, and chemotherapy delays, the trial aims to offer insights into long-term outcomes and potentially improve the quality of life for those affected by gynecologic cancers. This holistic approach could lead to more personalized and effective care strategies for patients with unique needs.
What evidence suggests that this physical function assessment is effective for gynecologic cancer?
Research shows that exercise can help women with gynecologic cancer enhance their physical abilities. Early results indicate that exercise boosts fitness, muscle strength, and agility. Even simple activities can maintain or improve overall health. However, many women who have had gynecologic cancer do not exercise much, with only about half meeting recommended activity levels. This trial will assess participants' physical function to identify those who might need extra support to stay active during their cancer journey.23467
Who Is on the Research Team?
Stephanie Cham, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Baseline Assessment
Participants undergo physical function assessments, complete surveys, and medical records review at the time of diagnosis
Follow-up
Participants are monitored for quality of life and oncologic outcomes after surgery
Long-term Follow-up
Medical record reviews to examine long-term oncologic outcomes such as progression free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Physical function assessment
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will undergo physical function assessments, complete surveys, and medical records every 3 months +/- 4 weeks prior to standard of care surgery (outside of this protocol). After surgery subjects will be followed for at least 3 months +/- 4 weeks for up to one year after diagnosis. Medical record reviews will occur periodically to examine for long-term follow up oncologic outcomes of progression free survival, overall survival, and chemotherapy delays for up to 10 years after enrollment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
American Society of Clinical Oncology
Collaborator
Conquer Cancer Foundation
Collaborator
National Institute on Aging (NIA)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
The impact of gynaecological cancer treatment on physical ...
This review demonstrated that compared to pre-diagnosis, levels of physical activity remain low in gynaecological cancer survivors up to 3 years after ...
Functional Impairment and Physical Activity Adherence ...
Fifty percent of ovarian cancer survivors reported meeting physical activity guidelines, whereas 40% of endometrial and 45% of cervical cancer survivors did so.
3.
international-journal-of-gynecological-cancer.com
international-journal-of-gynecological-cancer.com/article/S1048-891X(24)01212-X/fulltextPhysical activity trajectories following gynecological cancer
Women with endometrial cancer (58% of the sample) were more likely to be overweight or obese and to report low levels of physical activity or none at all.
Efficacy of exercise interventions for women during and after ...
Preliminary research into the role of exercise post-gynaecological cancer suggests an improvement in exercise capacity, muscular strength, and agility.
Evaluation of physical function and quality of life before ...
Nonradical surgery for early-stage cervical cancer is associated with excellent QOL and small decreases in physical function (bladder, bowel, sexual)
Association between physical activity and gynecological cancers
A meta-analysis of prospective cohort studies was conducted to evaluate the association between PA and GC risk, including endometrial cancer (EC) ...
A Cross-Sectional Study of NHANES 2007-2018
This study aimed to examine the associations of regular and “weekend warrior” PA patterns with the risk of cervical cancer (CC), ovarian cancer ...
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