Colorectal CancerRadPFDNCT04623515
Radiation Therapy on Pelvic Floor Disorders in Women
An observational study of Colorectal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- REDCap Questionnaires
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 14 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female survivors of colorectal cancer and their partners.
Who may be able to join
- 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.
Who cannot join
- No internet access.
- Non-English speakers (validated instruments are only available in English).
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27103
About this study
Official title: Exploring the Impact of Radiation Therapy on Pelvic Floor Disorders in Women Treated for Colorectal Cancer (RadPFD)
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
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- REDCap Questionnaires
- Keywords
- Survivors of colorectal cancer, Lower bowel tract symptoms, Urinary incontinence, Irritative voiding symptoms, Voiding dysfunction, Bowel incontinence, Defecatory dysfunction, Lower urinary tract symptoms
- Medical subject headings
- Colorectal Neoplasms, Urinary Incontinence, Fecal Incontinence, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REDCap QuestionnairesOther
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 ® .
| Study group | Role | What they receive |
|---|---|---|
| Surgery Only Group | Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. Receives: Other: REDCap Questionnaires | |
| Surgery and Radiation Therapy Group | Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. Receives: Other: REDCap Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 months
Secondary outcomes (5)
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
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.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start5 May 2021
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Why it stopped: IRB closure, slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Candace Parker-Autry, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623515
- Sponsor's protocol ID
- IRB00069825
- Other IDs
- WFBCCC 01620, P30CA012197
- Acronym
- RadPFD
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Radiation Therapy on Pelvic Floor Disorders in Women Treated for Colorectal Cancer (RadPFD)
- ClinicalTrials.gov ID
- NCT04623515
- Acronym / sponsor ID
- RadPFD / IRB00069825
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB closure, slow accrual
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Only Group | – | Other: REDCap QuestionnairesParticipants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. |
| Surgery and Radiation Therapy Group | – | Other: REDCap QuestionnairesParticipants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female survivors of colorectal cancer and their partners.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- No internet access.
- Non-English speakers (validated instruments are only available in English).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REDCap QuestionnairesOnce 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 ® . | Other | Surgery Only Group, Surgery and Radiation Therapy Group |
Primary outcome
Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time frame: Up to 4 months
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.
5 secondary outcomes
PROMIS® Brief Profile Sexual Function and Satisfaction (Female)
Time frame: Up to 4 months
Bowel Dysfunction - Modified Manchester Health Questionnaire
Time frame: Up to 4 months
PROMIS® Brief Profile Sexual Function and Satisfaction- Male or Female Partners
Time frame: Up to 4 months
Dyadic Adjustment Scale-Short Form (DAS-7) Questionnaire - Couple Relationship
Time frame: Up to 4 months
Short Form-12 Questionnaire - General Health and Well Being
Time frame: Up to 4 months
Results and safety
The study was stopped early (reason given: IRB closure, slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candace Parker-Autry, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB closure, slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.