Sexual DysfunctionNCT05837117
Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective
An observational study of Sexual Dysfunction, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Patient's Perspective
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 13 Dec 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- 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
Who cannot join
- New patients (consults)
- Patient who have declined to participate, or who are unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Sexual Dysfunction
- Being tested
- Patient's Perspective
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient's PerspectiveBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient's Perspective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaires
Measured: through study completion an average of year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start15 Dec 2022
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Bramati, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837117
- Sponsor's protocol ID
- 2022-0495
- Other IDs
- NCI-2022-10774
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective
- ClinicalTrials.gov ID
- NCT05837117
- Acronym / sponsor ID
- 2022-0495
- Conditions
- Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 1 May 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient's Perspective | – | Behavioral: Patient's PerspectiveParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- New patients (consults)
- Patient who have declined to participate, or who are unable to consent
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 |
|---|---|---|
| Patient's PerspectiveParticipants 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 | Behavioural | Patient's Perspective |
Primary outcome
Quality of Life Questionnaires
Time frame: through study completion an average of year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Patricia Bramati, MD principal investigator
M.D. Anderson Cancer Center
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 Sexual Dysfunction, run by M.D. Anderson Cancer Center 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 4 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: finished, as of the sponsor's last update on 19 Dec 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life Questionnaires (time frame: through study completion an average of year). 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 19 Dec 2024.