Breast Cancer Female
Conditions
Keywords
breast cancer, sexual health, factorial MOST design
Brief summary
The goal of this clinical trial is to develop an effective internet-delivered program to help breast cancer survivors manage cancer-related sexual concerns. This study is being done to find out if the study approach is better or worse than the usual approach to helping breast cancer survivors manage cancer-related sexual concerns. The usual approach is defined as care most cancer survivors get for their cancer-related sexual concerns. Participants will complete a questionnaire and if they qualify, they will be assigned to one of sixteen groups of participants. Groups will get access to various kinds of help through an Internet-delivered program called SHINE, which was designed and is run by researchers at the University of Virginia Center for Behavioral Health and Technology. All groups will get access to education about sexual health after cancer: either a standard education website or an enhanced education web program. Groups may also receive up to three additional web programs on: talking to your clinicians about sexual concerns, and/or talking to your partner about sexual concerns, and/or increasing intimacy. Participants are asked to complete the SHINE program within 12 weeks. After participants finish this 12-week period, the study team will ask them to complete a questionnaire to check in with the participant. The participant will be asked one additional time 12 weeks later to complete another questionnaire to see how the participant is doing. A participant will be in the study for 24 weeks.
Detailed description
This study has sixteen study groups with about twenty people in each group. Different groups receive different combinations of help. Participants will receive a certain combination of these four different Cores to make up their SHINE program. A Core is equal to one 20-45-minute lesson. Participants will receive access to all assigned Cores at one time. Participants can complete them at their own pace, as the SHINE program allows them to return where they left off. The four Cores are described below: * Education Core: A one-time education about sexual health after breast cancer by either a traditional webpage or by a web-based program. In the traditional webpage, a participant can read and review the information at their own pace. In the web-based program, a participant can also read and review the information at their own pace, and the information will be presented with interactive activities and email reminders. This one-time lesson should take the participant 20-45 minutes to complete. * Talking with a Clinicians Core: A participant may receive access to a web-based program about how to talk with their health care team about their sexual concerns. A participant can use this program at their own pace, and it will have information, activities, and email reminders. This one-time lesson should take a participant approximately 45 minutes to complete. * Talking with a Partner Core: A participant may receive access to a web-based program about how to talk with their partner about their sexual concerns. A participant can use this program at their own pace, and it will have information, activities, and email reminders. This one-time lesson should take a participant approximately 45 minutes to complete. * Intimacy Enhancement Core: A participant may receive access to a web-based program about how to increase their physical and emotional closeness with their partner. A participant can use this program at their own pace, and it will have information, activities, and email reminders. This one-time lesson should take the participant approximately 45 minutes to complete. Before you begin the study, your medical team will review your medical record. This helps your medical team decide if it is safe for you to take part in the study. If you join the study, you will have the usual care you would get even if you were not in the study. If you choose to take part in this study, you will be asked to fill out forms with questions about your sexual concerns, function, symptoms, and experiences, as well as relationship satisfaction and intimacy. In addition, you will be asked about your communication about sexual concerns with your medical team and partner. Finally, you will be asked for your thoughts about the SHINE program, and a little about your demographics, distress, daily lifestyle, physical activity, and tobacco use. Researchers will use this information to determine what combination of kinds of help delivered by the internet is best for breast cancer patients to better understand and address their sexual concerns. Participants will be asked to fill out questionnaires electronically from a link that is emailed to them three separate times during the study: * After a participant consents, before they can be randomized to a study group. * Approximately 12 weeks after the participant completes the first questionnaire. * Approximately 24 weeks after the participant completes the first questionnaire. Each questionnaire will take about 40 to 45 minutes to complete. Participants may skip any question for any reason.
Interventions
OTHERInternet-based Intervention
Receive access to SHINE modules
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Local NCORP site staff and study investigators will be blinded to the treatment assignment
Intervention model description
Factorial trial using the multiphase optimization strategy (MOST) framework, in which participants will be randomized to one of 16 conditions (2\^4) to receive access to a combination of one to four SHINE components.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of Stage 0-III breast cancer diagnosis. History of non-breast malignancies are permitted. * ≥12 weeks following last primary cancer treatment. For this protocol, primary cancer treatments are defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and surgical procedures intended to remove malignant tissue. Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2-based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors (e.g., neratinib), and/or pending breast reconstructive surgery are allowed. (There is no upper limit on time since treatment.) * Age ≥ 18 years at the time of study enrollment SELF-REPORTED ELIGIBILITY SCREENER INCLUSION * female * Currently in an intimate relationship, as reported on the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS SexFS) screener (this relationship may be with an individual of any sex) * Endorse being at least "somewhat" bothered by \>=1 of the following during the last 30 days: (lack of) interest in sexual activity, vaginal dryness, pain during sexual activity, or (in)ability to orgasm, as reported on the PROMIS SexFS Bother Regarding Sexual Function screener * Endorse that ≥ 1 of the bothersome sexual symptoms, from the PROMIS SexFS Bother Regarding Sexual Function screener is related to their breast cancer * Has a working email address (or willing to create one) and receive emails from the study
Exclusion criteria
* Planned cancer treatment for residual, progressive, or recurrent disease within the 24 weeks following enrollment (defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and/or surgical procedures intended to remove malignant tissue). Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2-based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors (e.g., neratinib), and/or pending breast reconstructive surgery are allowed. * Unable to read and comprehend English (SHINE intervention currently only available in English) as indicated by being unable to complete the self-reported screening questionnaire independently SELF-REPORTED ELIGIBILITY SCREENER EXCLUSION * Does not have reliable access to internet (e.g., by home broadband, public network, personal data plan) by computer, tablet, smartphone etc. and is not willing to participate in the tablet lending program for this study * Recent serious mental illness, as defined by reporting an inpatient psychiatric hospitalization within the past 12 months * Currently participating in couple, marital, or sex therapy * Currently pregnant (Pregnant women are excluded from this study because childbirth is accompanied by significant biological, psychological, and environmental changes that alter a woman's sexual functioning. Intervention content may not be medically appropriate for women who have recently given birth, given that medical providers commonly recommend that women avoid sexual contact for at least four to six weeks post-partum while healing.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual distress as measured by the total sum score of the Female Sexual Distress Scale - Desire, Arousal, Orgasm (FSDS-DAO). The total sum score ranges from 0-60 with higher scores reflecting greater distress. | From baseline to 24 weeks | Estimated mean change from Baseline to 24 weeks with main effect of Time will be obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants will be utilized in the model (ITT analysis). |
Countries
United States
Contacts
STUDY_CHAIRGlenn Lesser, MD
Wake Forest University Health Sciences
Outcome results
None listed