Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial

Breast Cancer Female Clinical Trial

— SHINE  

Official title:

Optimizing Psychosocial Intervention for Breast Cancer-Related Sexual Morbidity:The Sexual Health and Intimacy Education (SHINE) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216574
• Other study ID #: IRB00104518
• Secondary ID: NCI-2023-06866WF
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: August 2027

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Karen Craver
• Phone: 336-716-0891
• Email: NCORP[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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
• Cisgender female (i.e., assigned female at birth, female gender identity)
• 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 and gender identity)
• 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.)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Internet-based Intervention
Receive access to SHINE modules

Locations

Country	Name	City	State
United States	Mission Cancer and Blood - Ankeny	Ankeny	Iowa
United States	Rush-Copley Medical Center	Aurora	Illinois
United States	Illinois CancerCare-Bloomington	Bloomington	Illinois
United States	Minnesota Oncology - Burnsville	Burnsville	Minnesota
United States	Illinois CancerCare-Canton	Canton	Illinois
United States	Saint Anthony Regional Hospital	Carroll	Iowa
United States	Illinois CancerCare-Carthage	Carthage	Illinois
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa
United States	Mercy Cancer Center-West Lakes	Clive	Iowa
United States	Mission Cancer and Blood - West Des Moines	Clive	Iowa
United States	Mount Carmel East Hospital	Columbus	Ohio
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Carle at The Riverfront	Danville	Illinois
United States	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Broadlawns Medical Center	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mission Cancer and Blood - Des Moines	Des Moines	Iowa
United States	Mission Cancer and Blood - Laurel	Des Moines	Iowa
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Carle Physician Group-Effingham	Effingham	Illinois
United States	Crossroads Cancer Center	Effingham	Illinois
United States	Illinois CancerCare-Eureka	Eureka	Illinois
United States	Trinity Regional Medical Center	Fort Dodge	Iowa
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	Beebe South Coastal Health Campus	Frankford	Delaware
United States	CentraState Medical Center	Freehold	New Jersey
United States	Central Ohio Breast and Endocrine Surgery	Gahanna	Ohio
United States	Illinois CancerCare-Galesburg	Galesburg	Illinois
United States	Mount Carmel Grove City Hospital	Grove City	Ohio
United States	Mercy Hospital Joplin	Joplin	Missouri
United States	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois
United States	Illinois CancerCare-Macomb	Macomb	Illinois
United States	Fairview Clinics and Surgery Center Maple Grove	Maple Grove	Minnesota
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Monticello Cancer Center	Monticello	Minnesota
United States	Louisiana State University Health Science Center	New Orleans	Louisiana
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Westfields Hospital/Cancer Center of Western Wisconsin	New Richmond	Wisconsin
United States	New Ulm Medical Center	New Ulm	Minnesota
United States	Cancer Care Center of O'Fallon	O'Fallon	Illinois
United States	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma
United States	Lake Regional Hospital	Osage Beach	Missouri
United States	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois
United States	Illinois CancerCare-Pekin	Pekin	Illinois
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Illinois CancerCare-Peru	Peru	Illinois
United States	Illinois CancerCare-Princeton	Princeton	Illinois
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Springfield Clinic	Springfield	Illinois
United States	Springfield Memorial Hospital	Springfield	Illinois
United States	Carle Cancer Center	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Illinois CancerCare - Washington	Washington	Illinois
United States	Saint Ann's Hospital	Westerville	Ohio
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota
United States	Fairview Lakes Medical Center	Wyoming	Minnesota
United States	Rush-Copley Healthcare Center	Yorkville	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI), University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	From baseline to 24 weeks