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NCT03658161 · ClinicalTrials.gov registry record · NA
Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program
A NA study of Cancer, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT03658161: Completed NA study of Cancer, sponsored by Duke University.
NCT03658161 is a NA study of Cancer that has completed, run by Duke University. The registered enrollment target is 37 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03658161, a NA study of Cancer, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with cancer suffer many devastating side effects; one that is understudied but vital to quality of life is the effect of cancer and its treatments on patients' sexual functioning and satisfaction. The long-term goal of this work is to improve the care of patients with cancer who are experiencing difficulties with sexual function and satisfaction. As a necessary first step, providers must be skilled in eliciting patients' concerns about sexual health and addressing them appropriately. However, prior studies have found that (1) oncology providers are reluctant to discuss sexual issues with their patients, (2) patients report that needed conversations about their sexual concerns do not occur, and (3) patients want to discuss sexual health with their provider. Thus, the goal of the present study is to develop and test a brief intervention to improve oncology provider's skills in addressing patients' concerns regarding sexual function-the Communicating about Sexual Concerns and Dysfunction Effectively (CASCADE) Program. To aid in development of the intervention, focus groups will be held and target 9 distinct populations of cancer survivors: 1) Breast; 2) Gynecologic; 3) Prostate; 4) males with gastrointestinal malignancies; 5) females with gastrointestinal malignancies; 6) males with brain tumors; 7) females with brain tumors; 8) LGBTQ individuals who identify as male; 9) LGBTQ individuals who identify as female. Maximum accrual for this phase will be 90 patients for 9 focus groups, or a maximum of 10 patients per group. Groups will last approximately 75 minutes and be audio recorded. Participants will also complete self-report measures which as about their sexual functioning, emotional wellbeing, physical functioning and utilization of services offered through the Duke Cancer Institute. The intervention will then be pilot tested with up to 10 providers to assess feasibility and acceptability of the protocol. Specifically, the coaching intervention will inclu
Primary Outcome
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction scale asks participants to provide information about their sexual functioning and satisfaction over the last 30 days. Separate versions of the measure will be used for males and females to address gender-specific differences in sexual functioning (e.g., pain and discomfort in the clitoris or labia vs. ability to maintain an erection). The male version of the questionnaire consists of 10 items w
Conditions Studied
Interventions
- BEHAVIORAL Communicating About Sexual Concerns and Dysfunction Effectively
Study Locations (1)
North Carolina
- Duke Cancer Institute - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-01-06 |
| Est. Completion | 2019-06-25 |
| Phase | NA |
What the finished NCT03658161 record still lists
NCT03658161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Communicating About Sexual Concerns and Dysfunction Effectively is the first listed.
NCT03658161 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03658161 about?
NCT03658161 is a clinical study titled "Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program". Patients with cancer suffer many devastating side effects; one that is understudied but vital to quality of life is the effect of cancer and its treatments on patients' sexual functioning and satisfaction. The long-term goal of this work is to improve the care of patients with cancer who are experie...
What is the current status of trial NCT03658161?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2017-01-06. Estimated completion is 2019-06-25.
What conditions does trial NCT03658161 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT03658161?
The interventions under investigation include: Communicating About Sexual Concerns and Dysfunction Effectively (BEHAVIORAL).
Who is sponsoring clinical trial NCT03658161?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03658161 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03658161's enrollment target sits among peer trials
37 482nd of 615 higher than 132 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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