Radiation Therapy on Pelvic Floor Disorders in Women

NCT04623515 | Terminated DMC

• 3 other identifiers: IRB00069825WFBCCC 01620P30CA012197
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Cancer

Keywords

Survivors of colorectal cancer; Lower bowel tract symptoms; Urinary incontinence; Irritative voiding symptoms; Voiding dysfunction; Bowel incontinence; Defecatory dysfunction; Lower urinary tract symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• PROMIS® Brief Profile Sexual Function and Satisfaction (Female)

  Up to 4 months

• Bowel Dysfunction - Modified Manchester Health Questionnaire

  Up to 4 months

• PROMIS® Brief Profile Sexual Function and Satisfaction- Male or Female Partners

  Up to 4 months

• Dyadic Adjustment Scale-Short Form (DAS-7) Questionnaire - Couple Relationship

  Up to 4 months

• Short Form-12 Questionnaire - General Health and Well Being

  Up to 4 months

Study Arms (2)

Surgery Only Group

Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link.

Other: REDCap Questionnaires

Surgery and Radiation Therapy Group

Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link.

Other: REDCap Questionnaires

Interventions

REDCap Questionnaires OTHER

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 ® .

Surgery Only Group; Surgery and Radiation Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female survivors of colorectal cancer and their partners.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Urinary Incontinence; Fecal Incontinence; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Candace Parker-Autry, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 10, 2020
• Study Start: May 5, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)