Clinical trial NCT04623515: Radiation Therapy on Pelvic Floor Disorders in Women
Official title: Exploring the Impact of Radiation Therapy on Pelvic Floor Disorders in Women Treated for Colorectal Cancer (RadPFD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-10
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female survivors of colorectal cancer and their partners.

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
timeFrame: Up to 4 months
Secondary outcomes:
measure: PROMIS® Brief Profile Sexual Function and Satisfaction (Female)
timeFrame: Up to 4 months
measure: Bowel Dysfunction - Modified Manchester Health Questionnaire
timeFrame: Up to 4 months
measure: PROMIS® Brief Profile Sexual Function and Satisfaction- Male or Female Partners
timeFrame: Up to 4 months
measure: Dyadic Adjustment Scale-Short Form (DAS-7) Questionnaire - Couple Relationship
timeFrame: Up to 4 months
measure: Short Form-12 Questionnaire - General Health and Well Being
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Candace Parker-Autry, MD
role: PRINCIPAL_INVESTIGATOR
References: