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ACTIVE NOT RECRUITING

NCT06216574

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

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2024-03-14

Completion Date

2027-08-01

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Breast Cancer Female

Interventions

OTHER

Internet-based Intervention

Receive access to SHINE modules

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.)

Locations (236)

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Beebe South Coastal Health Campus

Frankford, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Atrium Health Navicent

Macon, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

Advocate Outpatient Center - Aurora

Aurora, Illinois, United States

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 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

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Advocate Sherman Hospital

Elgin, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Condell Memorial Hospital

Libertyville, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, 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

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

Illinois CancerCare - Washington

Washington, Illinois, United States

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

The University of Iowa - Ankeny

Ankeny, Iowa, United States

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

The University of Iowa - West De Moines

Clive, Iowa, United States

Iowa Methodist Medical Center