Improving Women's Function After Pelvic Radiation

Gynecologic Cancer Clinical Trial

Official title:

Integrated Physical Therapy and Coping Skills Training for Improving Women's Sexual Function After Pelvic Radiation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04544735
• Other study ID #: Pro00105435
• Status: Suspended
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 12
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Pelvic Floor Disorders
• Sexual Dysfunction

Intervention

Behavioral:
• Integrated Physical Therapy and Coping Skills Training
The proposed intervention will provide pelvic health physical therapy interventions including: education about vaginal moisturizers and lubricants, low back and hip assessment and instruction in accommodations (e.g., strategies for accommodating sexual position of choice), instruction in vulvar massage, instruction and facilitation of vaginal dilator use, and pelvic floor muscle training (PFMT) and exercises. Women will be given a set of vaginal dilators. Cognitive behavioral techniques that have been successfully used by physical therapists in prior intervention studies will be integrated into the PT intervention including breathing and relaxation techniques, guided imagery, systematic desensitization, cognitive restructuring techniques and coping thoughts, and problem solving

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Session Attendance	Treatment feasibility will be assessed by measuring the session attendance rate for each participant	Following completion of the intervention, up to 12 months
Primary	Attkisson & Zwick's Client Satisfaction Questionnaire	18 item questionnaire to measure and assess consumer satisfaction with health and human services.	3 months post intervention
Secondary	Sexual Vaginal Changes Questionnaire	27-item questionnaire to assess intimacy, sexual interest, sexual satisfaction, vaginal changes (lubrication, pain and bleeding) and sexual functioning	Baseline and 3 months post intervention
Secondary	Australian Pelvic Floor Questionnaire	42 item questionnaire to assesses all pelvic floor symptoms including bladder, bowel and sexual function and prolapse symptoms	Baseline and 3 month post intervention
Secondary	PROMIS Sexual Function and Satisfaction Measure Full Profile (Female)	27 item questionnaire to measure sexual function and satisfaction in female population with cancer in past 30 days	Baseline and 3 months post intervention
Secondary	Generalized Anxiety Disorder Screener (GAD-7)	7-item questionnaire to assess symptoms of anxiety over the past two weeks	Baseline and 3 months post intervention
Secondary	Patient Health Questionnaire Depression Screener (PHQ-9)	9-item questionnaire to asses depressive symptoms over the past two weeks	Baseline and 3 months post intervention
Secondary	Adherence to Rehabilitation Strategies Scale	3 item questionnaire to assess adherence to rehabilitation strategies such as vaginal dilators, moisturizers, pelvic floor muscle exercises.	Baseline and 3 months post intervention