Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Endometrial Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Neoplasms

Uterine Diseases

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Patients will be randomized at their pre-surgical consultation. Patients will undergo a physical therapy evaluation prior to surgery and at 4 and 8 weeks post-op. Their preoperative visits will be as close to 4 weeks before surgery as possible but given the urgency of some of these surgeries and diagnoses, treatment will not be delayed to complete the components of this study. The patient will also be asked to complete a quality of life assessment at the beginning and end of the study as well as an anonymous survey at the conclusion of the study evaluating her satisfaction with the experiment.

Patients will be randomized at their pre-surgical consultation. Patients will undergo a physical therapy evaluation, nutritional counseling and group therapy, prior to surgery and at 4 and 8 weeks post-op. Their preoperative visits will be as close to 4 weeks before surgery as possible but given the urgency of some of these surgeries and diagnoses, treatment will not be delayed to complete the components of this study. The patient will also be asked to complete a quality of life assessment at the beginning and end of the study as well as an anonymous survey at the conclusion of the study evaluating her satisfaction with the experiment. Patient nutritional assessments will be obtained with Patient Generated Subjective Global Assessment questionnaires as well as targeted questioning by the dietician.

Patients will receive physical therapy alone.

Unimodal

Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.

Trimodal

Shannon Grabosch, MD

Patients will be randomized to a unimodal or trimodal prehabilitation program prior to surgery for known or suspected gynecologic cancer.

Prehabilitation generally refers to the act of an intervention prior to a known potentially debilitating event. Usually taking the form of physical therapy prior to surgery, prehabilitation programs have demonstrated success in colorectal, urological, and surgical oncology cases. Patients with a gynecologic oncology diagnosis face an arduous course. Their treatment generally involves a major surgery and is often followed by chemotherapy, radiation, or both.The patient population is generally older in life as the average age for an endometrial or ovarian cancer diagnosis is 63. These patients may already have a lower performance status at baseline deeming their treatment course exponentially more difficult to endure. Women with gynecologic cancer suffer significant mental duress often living in fear of the high rates of recurrence from some of these malignancies suggesting they may benefit from psychologic support and counseling through their treatment.

Given the proven success in other surgical disciplines, we believe that instituting prehabilitation programs should be standard of care. Patients will be randomized to a trimodal approach (physical therapy, nutritional counseling, cognitive behavioral therapy) versus a unimodal intervention (physical therapy) for a formal prehabilitation program. Our primary outcome will be functional return to baseline following surgery with secondary outcomes including items such as quality of life assessments, patient satisfaction, and compliance.

Gyn Onc Prehab Study

Optimizing Prehabilitation in Gynecologic Oncology

Data will not be shared outside of members of the research team.

Patients will have a preoperative physical therapy assessment incorporating standard evaluations of a 6 minute walk test, grip strength, and timed up and go. These will serve as the individual patient's baseline for subsequent comparison after surgery.

Need for postoperative readmission with be monitored in each group.

Surgical or treatment complications with be monitored in each group.

Patients from each group will be asked to complete an anonymous survey evaluating their satisfaction with the program.

Patients will complete baseline and follow up quality of life assessments using the FACT-G (Functional Assessment of Cancer Therapy-General). This is a 28 question quality of life assessment with scores ranging from 0 to 112 (higher scores correlate with a higher quality of life).

Rate of program completion will be assessed for each group.

St. Louis University

Assistant Professor of Gynecologic Oncology

Digestive System Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Pancreatic patients will participate in the trimodal prehabilitation: nutrition, psychological and exercise support.

Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation: nutrition, psychological, and exercise support.

Trimodal prehabilitation

Ana Ruiz-Casado, MD

María Romero Elías, MsC

Maria Romero Elias, PhD

Ana Ruiz Casado, MD PhD

Pancreatic cancer is a disease with a very poor prognosis and less than 10% of these patients live beyond 5 years from diagnosis. Further, it is expected to become the second leading cause of death in the coming years. Today, surgery remains the cornerstone in curing this disease, but the addition of chemotherapy is needed to improve survival. The impact of adjuvant treatment has been previously demonstrated and its efficacy is absolute. However, neoadjuvant chemotherapy (pre-surgery) improves the results after surgery (achieving earlier stages and with better prognosis) and would lead to better survival results. Besides, the moment of cancer diagnosis is a moment of special receptivity to change lifestyles ("teachable moment").

Multimodal prehabilitation includes 1) physical exercise; 2) nutritional and 3) psychological support. The potential advantages of prehabilitation during neoadjuvant therapy would be 1) the possibility of achieving a better physical condition to face surgery; 2) fewer postoperative complications; 3) more likely to receive adjuvant treatment after surgery; 4) better physical function at the end of treatments. To date, most studies have focused on lung and prostate cancer, with a high prevalence of men in the series.

This strategy has previously been explored, showing that it is safe and feasible, (Loughney et al). We have not identified any study of trimodal prehabilitation during neoadjuvant treatment and none that has integrated motivational strategies to maintain adherence.

Patients during chemotherapy have perceived several adverse effects that could limit adherence to the program. In this regard, a review on the motivation and exercise in cancer survivors shows that it is necessary to apply theoretical frameworks to understand cognitive and motivational processes and develop educational interventions. The self-determination theory is one of the motivational theories most applied today to the analysis of factors related to the adoption of healthy lifestyles. Likewise, patients who are motivated are more likely to improve healthy habits and obtain greater adherence to exercise performance. Therefore, we aimed of carrying out an intervention (pilot study) in ten patients to describe the feasibility of a trimodal prehabilitation program in the hospital environment, applying motivational strategies and a mixed-method (face-to-face and online).

outcome measures refer to feasibility of the intervention:

Recruitment Attendance to the training sessions Attendance to psychologist and nutritionist sessions

And also to physical condition Cardiorespiratory fitness Muscular strength Body composition Physical activity Quality of life Fatigue score

All the participants will receive trimodal prehabilitation. Only one arm

Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study

Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions

EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer. Quality of Life questionnaire. C30. all scores of the QLQ-C30 were transformed linearly so that all scales ranged from 0 to 100. In the function scales higher scores represent a better level of functioning while in the case of symptom scales/items higher scores mark a higher level of symptomatology or problems.

PERFORM (Multidimensional scale 12-60. The higher the less fatigue)

percentage of intended doses that are administered in the due time

Percentage of patients with no viable cells in the surgical specimen

Patients that received at least two cycles after surgery

Qualitative methods. semi-structured interviews and observation

Hospital Anxiety and Depression Scale questionnaire. Values 8-21. The higher the worse

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gyn Onc Prehab Study	NCT04298827	Gynecologic Can... Ovarian Cancer Endometrial Can... Cervical Cancer Surgery Treatment Adher... Quality of Life	Unimodal Trimodal	18 Years - 90 Years	St. Louis University
Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment	NCT05722223	Pancreatic Neop...	Trimodal prehab...	18 Years -	Puerta de Hierro University Hospital
Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment	NCT05722223	Pancreatic Neop...	Trimodal prehab...	18 Years -	Puerta de Hierro University Hospital

Spots Global Cancer Trial Database for trimodal

Every month we try and update this database with for trimodal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for trimodal

Every month we try and update this database with for trimodal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trimodal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.