Clinical trial NCT03658161: Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program
Official title: Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Patients for Focus Groups: Patients treated at the Duke Cancer Institute will be recruited to participate. Patients who self-refer to the study will also be recruited to participate, and eligibility will be verified after completing informed consent. All participants will meet the following inclusion criteria: a) aged 18 years or older; b) able to speak and understand English; and c) diagnosis of breast, prostate, gynecologic, gastrointestinal, or brain cancer and treated at the Duke Cancer Institute. Patients participating in one of the two LGBTQ groups (i.e., LGBTQ individuals who identify as male; LGBTQ individuals who identify as female) must self-identify as gay, lesbian, bisexual, transgender, or queer.
* 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.
* Patients recruited for CASCADE: Patients treated at the Duke Cancer Institute will be recruited to complete the anonymous survey. All participants will meet the following inclusion criteria: a) aged 18 years or older; b) able to speak and understand English; and c) diagnosis of breast, prostate, gynecologic, or gastrointestinal cancer and treated 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).

Primary outcomes:
measure: PROMIS Sexual Function and Satisfaction v2 - brief profile (Sex-SF)
timeFrame: Focus group participants will complete this measure at the time of the focus group; up to 2 hours
measure: PROMIS four-item Anxiety Scale
timeFrame: Focus group participants will complete this measure at the time of the focus group; up to 2 hours
measure: PROMIS four-item Depression Scale
timeFrame: Focus group participants will complete this measure at the time of the focus group; up to 2 hours
measure: PROMIS four-item Physical Function scale
timeFrame: Focus group participants will complete this measure at the time of the focus group; up to 2 hours
measure: Psychosocial services use, preferences, and perceived barriers/facilitators questionnaire
timeFrame: Focus group participants will complete this measure at the time of the focus group; up to 2 hours
measure: Change in confidence in talking with patients about sexuality from baseline to assessment 2
timeFrame: Baseline and Assessment 2 (up to 1 year)
measure: Change in outcome expectancies from baseline to assessment 2
timeFrame: Baseline and Assessment 2 (up to 1 year)
measure: Change in comfort with sexual health discussions from baseline to assessment 2
timeFrame: Baseline and Assessment 2 (up to 1 year)
measure: Communication with providers
timeFrame: One time patient survey (15 minutes)
measure: NCCN distress screen
timeFrame: One time patient survey (15 minutes)
measure: Service Utilization
timeFrame: One time patient survey (15 minutes)
measure: Usefulness of the intervention
timeFrame: Assessment 2 (up to 1 year)
measure: Likelihood the intervention would change clinical practice
timeFrame: Assessment 2 (up to 1 year)
measure: Likelihood providers would recommend the program to a colleague
timeFrame: Assessment 2 (up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Kevin P Weinfurt, PhD
role: PRINCIPAL_INVESTIGATOR
References: