Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program — CASCADE  

Cancer Clinical Trial

Official title: Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program

Status Completed

Clinical Trial 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 include two parts: 1) initial coaching session with one of the study PIs, Dr. Kathryn Pollak; and 2) follow-up appointment with Dr. Pollak to check in on use of the intervention strategies. Providers will also complete self-report assessments prior to initiating CASCADE and upon completion of CASCADE. Clinic staff will let patients know that the clinic is participating in a research study about how to improve communication between patients and providers and provide patients of participating providers with an anonymous survey to complete following their clinic visit. The paper surveys will be given to all patients of the participating provider being seen in the clinic approximately 5 days prior to the coaching intervention session and 5 days following the intervention (e.g., second session with Dr. Pollak).

Descriptive statistics (e.g., means, standard deviations) will be used to characterize the experience of patients participating in focus groups with regard to their sexual functioning, emotional distress (i.e., symptoms of anxiety and depression), and physical functioning. Qualitative methods will also be used to analyze the focus groups.

Feasibility of CASCADE will be assessed by examining providers' accrual, attrition, and adherence. To determine acceptability, providers will be asked how useful the intervention was, whether the intervention will change their clinical practice, and whether they would recommend the program to a colleague. Simple t-tests will be used to examine changes in outcomes of interest (e.g., confidence, barriers, etc.) from pre- to post-intervention. Basic descriptive statistics (e.g., means, standard deviations) will be used to characterize patients' experiences during the interaction.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cancer

• NCT number: NCT03658161
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: January 6, 2017
• Completion date: June 25, 2019