Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05837117
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 29.5
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction	Behavioral: Patient's Perspective

Detailed Description

Primary Objectives:

1. To determine the frequency of discussion about sexual dysfunction in palliative care patients.

2. To evaluate the impact of cancer diagnosis and treatment on patient's sexual life.

Secondary Objectives:

1. To evaluate patient self-reported severity of sexual dysfunction

2. To evaluate the proportion of patients suffering distress from body image concerns

3. To identify patient self-reported barriers that prevent discussion about sexual dysfunction

4. To evaluate patient self-reported impact of sexual dysfunction on their wellbeing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sexual Dysfunction in Palliative Care Patients: An Assessment of Patient's Perspective
• Actual Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm

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.

Behavioral: Patient's Perspective; 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

Outcome Measures

Primary Outcome Measures

1. Quality of Life Questionnaires [through study completion an average of year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Patricia Bramati, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05837117
• Other Study ID Numbers: 2022-0495; NCI-2022-10774
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 1, 2023