- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05837117
Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective
February 20, 2024 updated by: M.D. Anderson Cancer Center
To learn about the communications that Supportive Care patients receive about sexual well-being from their healthcare provider.
Researchers also want to learn about your attitudes, beliefs, and feelings about sexual well-being.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Primary Objectives:
- To determine the frequency of discussion about sexual dysfunction in palliative care patients.
- To evaluate the impact of cancer diagnosis and treatment on patient's sexual life.
Secondary Objectives:
- To evaluate patient self-reported severity of sexual dysfunction
- To evaluate the proportion of patients suffering distress from body image concerns
- To identify patient self-reported barriers that prevent discussion about sexual dysfunction
- To evaluate patient self-reported impact of sexual dysfunction on their wellbeing
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patricia Bramati, MD
- Phone Number: (832) 829-1680
- Email: pbramati@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
M D Anderson Cancer Center
Description
Inclusion Criteria:
- All patients who are evaluated as follow-ups in the Supportive Care clinic, and able to voluntarily consent to participate in the study
- Patients must be able to understand, read, write, and speak English
- Diagnosis of cancer
- Patients who are 18 years of age or older
Exclusion criteria:
- New patients (consults)
- Patient who have declined to participate, or who are unable to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient's Perspective
Participants will complete a questionnaire about sexual wellbeing, sexual dysfunction, and communication with your provider on this topic.
Participants may choose to complete the questionnaire electronically (via email link), in-person, or over the phone, whichever you prefer.
Your demographic information (such as age, gender, ethnicity, marital status, and cancer diagnosis) will be collected from your medical record.
Some of this information may also be asked of you during the questionnaire.
|
Participants will complete a questionnaire about sexual wellbeing, sexual dysfunction, and communication with your provider on this topic. Participants/Researchers will learn about your attitudes, beliefs, and feelings about sexual well-being |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life Questionnaires
Time Frame: through study completion an average of year
|
through study completion an average of year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patricia Bramati, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2022
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
April 19, 2023
First Submitted That Met QC Criteria
April 19, 2023
First Posted (Actual)
May 1, 2023
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2022-0495
- NCI-2022-10774 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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