Clinical trial NCT04544735: Improving Women's Function After Pelvic Radiation
Official title: Integrated Physical Therapy and Coping Skills Training for Improving Women's Sexual Function After Pelvic Radiation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Sexual Dysfunction
Pelvic Floor Disorders
Gynecologic Cancer
Keywords: Pelvic radiation
Sexual side effects
Pelvic health physical therapy
Cancer survivors
Intimacy dysfunction
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The 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 after pelvic radiation.

Detailed description: Pelvic radiation, which is a critical component in the treatment of many gynecologic, bladder, rectal and anal cancers, often results in devastating and long-lasting sexual side effects. Vaginal changes following pelvic radiation include adhesions, agglutination, fibrosis, dryness, atrophy, and stenosis. Pelvic radiation-related sexual problems are often undertreated, resulting in poor symptom management and reduced quality of life. Rehabilitation programs including pelvic floor muscle training (PFMT) and vaginal dilator exercises may help minimize post-radiation vaginal changes and related sexual problems, but use of these rehabilitation strategies is inconsistent and infrequent in routine clinical practice. For many women, engaging in these rehabilitation strategies can be difficult and adherence is low (e.g.,1% to 35% for dilator use). Barriers to engaging in PFMT and dilator exercises include lack of information, pain, embarrassment, fear, and reliving invasive treatments. There is a critical need for interventions to help women access and engage in rehabilitation following pelvic radiation treatment. We propose to develop and pilot test a novel physical therapist delivered intervention to improve women's sexual function after pelvic radiation that integrates pelvic health physical therapy interventions (i.e., vaginal dilators, PFMT) and cognitive-behavioral based coping skills training for managing symptoms and improving treatment adherence. Pelvic health physical therapy interventions have demonstrated effectiveness for treating pelvic pain and sexual pain disorders. Coping skills training interventions have demonstrated benefits for reducing symptoms and improving treatment engagement.This study includes two phases: intervention development and pilot testing. For intervention development (months 1-6), qualitative data obtained from patient and healthcare provider interviews will be used to develop and refine the integrated PT and coping skills training intervention. Using information obtained in qualitative interviews, we will develop the intervention. In pilot testing (months 7-12), we will pilot the developed intervention with women who were treated with pelvic radiation. : The specific aims of this study are to: 1) develop and refine an integrated PT and coping skills training intervention based on qualitative data from interviews with cancer survivors, oncology providers, and pelvic health physical therapists; 2) pilot the developed intervention to examine its feasibility and acceptability; and 3) examine the patterns of change and relationships among outcome variables including vaginal changes, pelvic floor function, sexual function and satisfaction, and use of rehabilitation exercises.

Eligibility criteria: Cancer Survivors participating in the Intervention Development Interviews

Inclusion Criteria:

* Diagnosis of non-metastatic gynecologic (cervical, endometrial, vaginal, vulvar), anal, rectal, or bladder cancer
* Completed pelvic radiation treatment within the last 5 years
* 18 years of age or older
* Able to speak/read English
* Able to give meaningful informed consent

Exclusion Criteria:

* Major untreated or uncontrolled mental illness (e.g., schizophrenia)
* Unable to provide informed consent

Medical Providers Participating in Intervention Development Interviews

Eligibility Criteria:

* 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.
* Physical therapists with specialized certification in pelvic health or women's health physical therapy who provide care to patients in the outpatient setting.

Cancer Survivor User Testers

Inclusion Criteria:

* Diagnosis of non-metastatic gynecologic (cervical, endometrial, vaginal, vulvar), anal, rectal, or bladder cancer
* Completed pelvic radiation treatment in the past 2 to 24 months
* 18 years of age or older
* Able to speak/read English
* Able to give meaningful informed consent

Exclusion Criteria:

* Major untreated or uncontrolled mental illness (e.g., schizophrenia)
* Unable to provide informed consent

Primary outcomes:
measure: Session Attendance
timeFrame: Following completion of the intervention, up to 12 months
measure: Attkisson & Zwick's Client Satisfaction Questionnaire
timeFrame: 3 months post intervention
Secondary outcomes:
measure: Sexual Vaginal Changes Questionnaire
timeFrame: Baseline and 3 months post intervention
measure: Australian Pelvic Floor Questionnaire
timeFrame: Baseline and 3 month post intervention
measure: PROMIS Sexual Function and Satisfaction Measure Full Profile (Female)
timeFrame: Baseline and 3 months post intervention
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline and 3 months post intervention
measure: Patient Health Questionnaire Depression Screener (PHQ-9)
timeFrame: Baseline and 3 months post intervention
measure: Adherence to Rehabilitation Strategies Scale
timeFrame: Baseline and 3 months post intervention
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Rebecca Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References: