Prehabilitation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-005226
NCT ID: NCT05047926
Sponsor Protocol Number: 21-005226
About this study
Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.
It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer –specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer patients. Most current studied mindfulness-based interventions are limited by the time commitment required by the patient, which is difficult for patients with advanced cancer undergoing treatment, therefore we have created a virtual program that is more easily accessible by patients.
Frailty is thought to be mediated by senescent cells and their dynamic secretome, referred to as the senescence-associated secretory phenotype (SASP). Senescent cells contribute to age-related tissue deterioration, inflammation, and fibrosis. A group of novel frailty biomarkers obtained at the time of diagnosis has been examined in advanced OC patients. Preliminary data show that these biomarkers strongly correlate with the clinical frailty phenotype, and define a frail subgroup of patients with higher treatment related morbidity and worse survival. These markers may represent important surrogate clinical trial endpoints, as well as deepen the understanding of aging in women with ovarian cancer. In this pilot, these markers and other surrogate endpoints for future novel translational research in the science of aging will be explored.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Females, age 18 years or older.
- Diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer based on imaging and physician diagnosis.
- Suspected Stage IIIC or IV disease based on clinician staging and imaging.
- Curative intent treatment with platinum-based chemotherapy.
- Planned surgical intervention at some point during treatment course.
- Ability to read English.
- No diagnosed severe cognitive impairment.
- Ability to provide informed consent.
- Ability to utilize technology to watch online modules for the Resilient Living Program.
Exclusion Criteria:
- Females under 18 years of age.
- Hemiplegia or paraplegia.
- Current pregnancy.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available