Radiation Therapy on Pelvic Floor Disorders in Women

Colorectal Cancer Clinical Trial

— RadPFD  

Official title:

Exploring the Impact of Radiation Therapy on Pelvic Floor Disorders in Women Treated for Colorectal Cancer (RadPFD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04623515
• Other study ID #: IRB00069825
• Secondary ID: WFBCCC 01620P30C
• Status: Terminated
• Start date: May 5, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators propose a retrospective cohort study to examine the impact of radiation therapy on the global pelvic floor function of women who have completed the immediate surveillance period for colorectal cancer

Description:

Primary Objective: To characterize the impact of radiation therapy on the lower urinary and bowel tract symptoms, (featuring urinary incontinence, irritative voiding symptoms, voiding dysfunction, bowel incontinence, and defecatory dysfunction) of female survivors of colorectal cancer 2-5 years after treatment. Secondary Objectives: - To characterize sexual dysfunctions present in female colorectal cancer survivors 2-5 years after treatment and to determine the impact of radiation therapy compared to surgical treatment alone. - To examine the impact of radiation therapy on the sexual function of the partner of female survivors of colorectal cancer treated with radiation treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Living, female patients.
• Age 18 or older with a diagnosis of colorectal cancer (current or past, regardless of Stage)-confirmed by pathology report - made between the years of 2015 and 2018.
• History of treatment for colorectal cancer in the Wake Forest Baptist Health System.
• Sexual partners of the above participants (subjects can participate even if they are not sexually active or if no sexual partner is available).
• English speaking.

Exclusion Criteria:

• No internet access.
• Non-English speakers (validated instruments are only available in English).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Pelvic Floor Disorders

Intervention

Other:
• REDCap Questionnaires
Once consent is obtained, the participants will be routed to a REDCap secure link. Participants will complete a questionnaires regarding demographics and medical history. Participants will also complete validated questionnaires regarding their lower urinary and bowel tract function and sexual health- International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Modified Manchester Health Questionnaire (MMHQ), PROMIS® v2.0 Brief Profile Sexual Function and Satisfaction (Female) and SF-12 ® .

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)	The ICIQ-FLUTS is a 12-item validated, self-administered questionnaire that is derived from the Bristol Female Lower Urinary Tract Symptoms (BF-LUTS) questionnaire and designed for use in women and to assess urinary symptoms and effects on quality of life. There are 3 subscales within this instrument to assess incontinence, voiding and filling. Investigators will specifically use the incontinence subscale as the primary outcome. The instrument is based on 5 questions, with possible answers on a 5-point scale (ranging from "never" to "all of the time"). Scoring is 0-48 with higher scores equaling to a greater bother with urinary dysfunction in participants.	Up to 4 months
Secondary	PROMIS® Brief Profile Sexual Function and Satisfaction (Female)	This is a 14-item validated questionnaire that has been validated for use in cancer populations to assess female sexual function. Scoring is 0-100 with lower numbers indicating worse sexual function.	Up to 4 months
Secondary	Bowel Dysfunction - Modified Manchester Health Questionnaire	This is a 31-item patient reported outcome measure that is designed to assess degree and severity of bowel dysfunction and the impact of this dysfunction on quality of life. Scoring is 0-100 with higher scores indicating worse bowel function.	Up to 4 months
Secondary	PROMIS® Brief Profile Sexual Function and Satisfaction- Male or Female Partners	The PROMIS® Brief Profile Sexual Function and Satisfaction is an 11-item validated questionnaire that has been validated in a heterogeneous population to assess partner sexual function. Scoring is 0-100 with lower numbers indicating worse sexual function.	Up to 4 months
Secondary	Dyadic Adjustment Scale-Short Form (DAS-7) Questionnaire - Couple Relationship	This is a 7-item questionnaire to assess the quality of dyadic relationship designed for cohabitating or married couples. Score range is 0-36 with higher scores indicating better function.	Up to 4 months
Secondary	Short Form-12 Questionnaire - General Health and Well Being	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Scoring is 0-100 with higher scores indicating better function in the participant.	Up to 4 months