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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06216574
Other study ID # IRB00104518
Secondary ID NCI-2023-06866WF
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.)

Study Design


Related Conditions & MeSH terms


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
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