Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial
SHINE
Optimizing Psychosocial Intervention for Breast Cancer-Related Sexual Morbidity:The Sexual Health and Intimacy Education (SHINE) Trial
4 other identifiers
interventional
340
1 country
236
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
236 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedStudy Start
First participant enrolled
March 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
February 18, 2026
February 1, 2026
3.4 years
January 10, 2024
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (16)
SHINE 1
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 2
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
SHINE 3
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 4
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.
SHINE 5
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 6
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
SHINE 7
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 8
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids.
SHINE 9
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 10
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
SHINE 11
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 12
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy -NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.
SHINE 13
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 14
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
SHINE 15
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
SHINE 16
EXPERIMENTALSHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
Interventions
Receive access to SHINE modules
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- National Cancer Institute (NCI)collaborator
- University of Virginiacollaborator
Study Sites (236)
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, 95405, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Beebe South Coastal Health Campus
Frankford, Delaware, 19945, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Atrium Health Navicent
Macon, Georgia, 31201, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
The University of Iowa - Ankeny
Ankeny, Iowa, 50023, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
The University of Iowa - West De Moines
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
The University of Iowa - Des Moines
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
The University of Iowa - Laurel
Des Moines, Iowa, 50314, United States
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine, 04005, United States
Penobscot Bay Medical Center
Rockport, Maine, 04856, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine, 04073, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
Maine Medical Partners - South Portland
South Portland, Maine, 04106, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Essentia Health - Ely Clinic
Ely, Minnesota, 55731, United States
Essentia Health - Fosston
Fosston, Minnesota, 56542, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
CentraState Medical Center
Freehold, New Jersey, 07728, United States
Hackettstown Medical Center
Hackettstown, New Jersey, 07840, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Newton Medical Center
Newton, New Jersey, 07860, United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534, United States
Chilton Medical Center
Pompton, New Jersey, 07444, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Randolph Health Cancer Center
Asheboro, North Carolina, 27203, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, 27410, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Saint Charles Health System-Redmond
Redmond, Oregon, 97756, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Beaufort Memorial Hospital
Beaufort, South Carolina, 29902, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Beaufort Memorial/New River Cancer Center
Okatie, South Carolina, 29909, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
SMC Center for Hematology Oncology-Union
Union, South Carolina, 29379, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120, United States
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Shenandoah Oncology PC
Winchester, Virginia, 22601, United States
Kaiser Permanente Bellevue Medical Center
Bellevue, Washington, 98004, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956, United States
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961, United States
Westfields Hospital/Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (1)
Shaffer KM, Reese JB, Dressler EV, Glazer JV, Cohn W, Showalter SL, Clayton AH, Danhauer SC, Loch M, Kadi M, Smith C, Weaver KE, Lesser GJ, Ritterband LM. Factorial Trial to Optimize an Internet-Delivered Intervention for Sexual Health After Breast Cancer: Protocol for the WF-2202 Sexual Health and Intimacy Enhancement (SHINE) Trial. JMIR Res Protoc. 2024 Aug 19;13:e57781. doi: 10.2196/57781.
PMID: 39159450DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Glenn Lesser, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Local NCORP site staff and study investigators will be blinded to the treatment assignment
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2024
First Posted
January 22, 2024
Study Start
March 14, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be submitted to the archive 6 months post-publication and maintained according to data archive guidelines.
- Access Criteria
- upon request to NCORP@wakehealth.edu
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.