Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program

NCT ID: NCT03658161

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2019-06-25

Brief 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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CASCADE

Oncology providers will receive the CASCADE coaching intervention.

Group Type: EXPERIMENTAL

Communicating About Sexual Concerns and Dysfunction Effectively

Intervention Type: BEHAVIORAL

The coaching intervention will include two parts: 1) initial coaching session, and 2) follow-up appointment to check in on use of the intervention strategies.

Interventions

Communicating About Sexual Concerns and Dysfunction Effectively

The coaching intervention will include two parts: 1) initial coaching session, and 2) follow-up appointment to check in on use of the intervention strategies.

Intervention Type: BEHAVIORAL

Other Intervention Names

CASCADE

Eligibility Criteria

Inclusion Criteria

• Providers: We will recruit a total of 8 providers from the Duke Cancer Institute, including 2 from each type of cancer that we are targeting (breast, gynecologic, colorectal, and prostate). Within each cancer site, we will recruit one physician and one physician-extender (physician assistant, nurse practitioner, or nurse) to represent the range of provider types. Eligible providers will be currently treating patients in one of the above listed disease groups at the Duke Cancer Institute.

Exclusion Criteria

• Patients for Focus Groups: Patients who meet any of the following criteria will be excluded: a) < 18 years old; b) cognitive or hearing impairment that is documented in the medical record, or c) unable to provide meaningful consent (i.e., severe cognitive impairment such that descriptions of the research are not clearly understood).
• Providers: Providers who treat cancers other than breast, gynecologic, colorectal, and prostate cancers will not be eligible to participate.
• Patients for CASCADE: Patients who meet any of the following criteria will be excluded: a) < 18 years old; b) cognitive or hearing impairment that is documented in the medical record, or c) unable to provide meaningful consent (i.e., severe cognitive impairment such that descriptions of the research are not clearly understood).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin P Weinfurt, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Cancer Institute

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00071979

Identifier Type: -

Identifier Source: org_study_id