Communicating About Sexual Concerns and Dysfunction Effectively (CASCADE) Program
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/8/2018 |
Start Date: | January 6, 2017 |
End Date: | June 30, 2020 |
Contact: | Caroline S Dorfman, PhD |
Email: | caroline.dorfman@duke.edu |
Phone: | 919-416-3473 |
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.
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.
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).
We found this trial at
1
site
20 Duke Clinic Cir
Durham, North Carolina 27710
Durham, North Carolina 27710
(888) 275-3853
Principal Investigator: Kevin P Weinfrut, PhD
Phone: 919-416-3473
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
Click here to add this to my saved trials