Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216574
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-01-10
Brief Title:
Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors SHINE Trial
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Optimizing Psychosocial Intervention for Breast Cancer-Related Sexual MorbidityThe Sexual Health and Intimacy Education SHINE Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE
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 andor talking to your partner about sexual concerns andor 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
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 andor talking to your partner about sexual concerns andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R37CA269776 | NIH | Wake Forest NCORP Research Base | httpsreporternihgovquickSearchR37CA269776 |
| NCI-2023-06866 | REGISTRY | None | None |
| WF-2202 | OTHER | None | None |