Physical Therapy + Coping Skills for Gynecologic Cancer

RS
Overseen ByRebecca Shelby, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach that combines physical therapy (PT) and coping skills training to help women improve sexual function after pelvic radiation for certain cancers. The treatment includes exercises for pelvic health and training to better manage symptoms. Women who have received pelvic radiation for non-spreading gynecologic, anal, rectal, or bladder cancer in the last two years and experience related issues might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance quality of life.

Do I need to stop my current medications for the 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 intervention is safe for improving sexual function after pelvic radiation?

Research has shown that combining physical therapy with coping skills training is generally safe for individuals undergoing treatment for gynecologic cancers. Studies have examined how these methods assist women who have undergone pelvic radiation, focusing on enhancing physical abilities and managing symptoms. Physical therapy may include exercises such as pelvic floor muscle training, which can improve muscle control in the pelvic area. Coping skills aim to help manage stress and maintain adherence to the treatment plan.

Most studies have not reported serious side effects from these treatments, indicating they are usually well-tolerated. However, individual reactions can vary. Prospective trial participants should discuss any concerns with their healthcare provider.12345

Why are researchers excited about this trial?

Researchers are excited about the integrated physical therapy and coping skills training for gynecologic cancer because it combines physical and psychological support in a way that’s rarely done. While standard treatments often focus solely on the physical aspects, like pelvic floor exercises or dilator use, this approach adds coping skills to help manage symptoms and improve adherence to treatment. This dual focus aims to enhance women's sexual function after pelvic radiation by addressing both the body and the mind, potentially offering more comprehensive and effective care.

What evidence suggests that this integrated physical therapy and coping skills training is effective for improving sexual function after pelvic radiation?

Studies have shown that physical therapy, including exercises for the pelvic floor muscles and the use of vaginal dilators, can improve sexual function after pelvic radiation. Research indicates that pelvic floor therapy can reduce radiation side effects, such as incontinence, which impacts sexual health. Additionally, learning coping skills helps women manage symptoms and adhere to their treatment plans. This trial will evaluate the combined approach of integrating physical therapy with coping skills training, which early findings suggest could help women regain better sexual function after treatment.13678

Who Is on the Research Team?

RS

Rebecca Shelby, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for women who have had non-metastatic gynecologic, anal, rectal, or bladder cancer and completed pelvic radiation in the last 2-24 months. It includes oncology providers and physical therapists with specialized certification. Participants must speak/read English and be able to consent.

Inclusion Criteria

You have been diagnosed with cancer in your cervix, uterus, vagina, vulva, anus, rectum, or bladder, but it has not spread to other parts of your body.
You have had radiation treatment in your pelvic area within the last 2 to 24 months.
Oncology providers (e.g., radiation, medical, and surgical oncologists; nurses; advanced practice professionals) who provide care to women who receive pelvic radiation for gynecologic, anal, rectal or bladder cancers.
See 4 more

Exclusion Criteria

Unable to provide informed consent
You have a severe mental illness that is not being treated or controlled.

Timeline for a Trial Participant

Intervention Development

Qualitative data obtained from patient and healthcare provider interviews will be used to develop and refine the integrated PT and coping skills training intervention.

6 months

Pilot Testing

Pilot the developed intervention with women who were treated with pelvic radiation to examine its feasibility and acceptability.

6 months

Follow-up

Participants are monitored for changes in vaginal changes, pelvic floor function, sexual function and satisfaction, and use of rehabilitation exercises.

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Physical Therapy and Coping Skills Training
Trial Overview The study tests a new approach combining physical therapy with coping skills training aimed at improving sexual function after pelvic radiation treatment in women.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Integrated Physical Therapy and Coping Skills TrainingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Improving Women's Function After Pelvic RadiationThe purpose of the study is to develop and test an intervention combining physical therapy (PT) and coping skills training to improve women's sexual function ...
Physical Therapy and Coping Skills Training for Improving ...This clinical trial studies the experiences and needs of women who have received pelvic radiation for gynecologic, anal, rectal or bladder cancer.
Role of Physical Rehabilitation Including Pelvic Floor ...The present study aims to describe: 1. How the side effects of radiotherapy (RT) could impact sexual health in women; 2. The effectiveness of ...
An Integrative Medicine Educational Program for Radiation ...A radiation-specific IMEP resulted in a high rate of intention to disclose CHA use and improvements in patients' reported self-efficacy to manage radiation- ...
5.internationaljournalofcaringsciences.orginternationaljournalofcaringsciences.org/docs/43.lochana.pdf
The Impact of Pre-Treatment Nurse-Led Pelvic Floor ...This review evaluates the effectiveness of pre- treatment nurse-led pelvic floor exercises (PFEs) in reducing radiotherapy-induced incontinence (RII) in ...
Exploring prehabilitation interventions for patients with ...Radiotherapy imposes a significant physiological and psychological burden on gynaecological cancer patients.
Prehabilitation for Gynecological Cancer Radiotherapy PatientsPurpose. Radiotherapy imposes a significant physiological and psychological burden on gynaeco- logical cancer patients.
Prehabilitation for Gynecological Cancer Radiotherapy PatientsRadiotherapy imposes a significant physiological and psychological burden on gynaecological cancer patients. Prehabilitation is being increasingly used to ...
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