Online Sexual Health Program for Breast Cancer Survivors

(SHINE Trial)

Recruiting at 246 trial locations

Overseen By Karen Craver

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Endocrine therapy, cdk 4/6-inhibitors

Disqualifiers: Planned cancer treatment, Recent mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

340 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, ongoing treatments like endocrine therapy and certain cancer medications are allowed during the study.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, ongoing treatments like adjuvant endocrine therapy and certain other cancer-related medications are allowed during the study.

What data supports the effectiveness of the SHINE Program treatment for breast cancer survivors?

Research shows that group-based sexual education can effectively improve sexual behaviors in women with breast cancer, similar to individual counseling. Additionally, online self-help interventions have been beneficial for sexual problems after cancer, suggesting that the SHINE Program, which is an online sexual health program, may also be effective. ^{1 2 3 4 5}

What data supports the effectiveness of the SHINE Program treatment for breast cancer survivors?

Research shows that group-based sexual education can effectively improve sexual behaviors in women with breast cancer, similar to individual counseling. Additionally, online self-help interventions have been beneficial for sexual problems after cancer, suggesting that the SHINE Program, which is an online sexual health program, may also be effective. ^{1 2 3 4 5}

Is the Online Sexual Health Program for Breast Cancer Survivors safe for humans?

The research does not provide specific safety data for the Online Sexual Health Program or its variants, but similar interventions have been used in cancer survivors without reported safety concerns. ^{1 2 3 4 6}

How is the SHINE Program treatment different from other treatments for sexual health issues in breast cancer survivors?

The SHINE Program is unique because it is an online sexual health program specifically designed for breast cancer survivors, making it widely accessible and comfortable for participants. Unlike traditional in-person counseling, it offers a self-help approach that can be accessed from anywhere, potentially increasing its reach and convenience for users. ^{1 3 4 7 8}

How is the SHINE Program treatment different from other treatments for sexual health in breast cancer survivors?

The SHINE Program is unique because it is an online sexual health program specifically designed for breast cancer survivors, making it widely accessible and comfortable for participants. Unlike traditional in-person counseling, it offers a self-help approach that can be accessed from anywhere, potentially increasing its reach and convenience for users. ^{1 3 4 7 8}

Research Team

Glenn Lesser, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for cisgender female breast cancer survivors who are at least 18 years old, have finished primary cancer treatments like chemotherapy or surgery at least 12 weeks ago, and are currently in an intimate relationship. They should be somewhat bothered by sexual issues such as low interest, dryness, pain during sex, or orgasm difficulties due to their cancer.

Inclusion Criteria

I have experienced sexual function issues like lack of interest, dryness, pain, or trouble with orgasm in the last month.

Currently in an intimate relationship, as reported on the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS SexFS) screener

I am 18 years old or older.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete the SHINE program, which includes various web-based educational and interactive components tailored to address sexual health concerns over a 12-week period.

12 weeks

Online access at participant's convenience

Follow-up

Participants are monitored for changes in sexual distress and other outcomes through questionnaires administered at 12 and 24 weeks after the start of the study.

12 weeks

2 electronic questionnaires

Treatment Details

Interventions

• SHINE Program

Trial Overview The SHINE Trial tests an internet-delivered program designed to help manage sexual health concerns after breast cancer. Participants will use the SHINE program with educational content and may receive additional modules on communication with clinicians and partners or increasing intimacy over a period of 24 weeks.

Participant Groups

Group I: SHINE 9 Experimental Treatment 1 Intervention

SHINE 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.

Group II: SHINE 8 Experimental Treatment 1 Intervention

SHINE 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.

Group III: SHINE 7 Experimental Treatment 1 Intervention

SHINE 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.

Group IV: SHINE 6 Experimental Treatment 1 Intervention

SHINE 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.

Group V: SHINE 5 Experimental Treatment 1 Intervention

SHINE 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.

Group VI: SHINE 4 Experimental Treatment 1 Intervention

SHINE 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.

Group VII: SHINE 3 Experimental Treatment 1 Intervention

SHINE 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.

Group VIII: SHINE 2 Experimental Treatment 1 Intervention

SHINE 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.

Group IX: SHINE 16 Experimental Treatment 1 Intervention

SHINE 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.

Group X: SHINE 15 Experimental Treatment 1 Intervention

SHINE 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.

Group XI: SHINE 14 Experimental Treatment 1 Intervention

SHINE 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.

Group XII: SHINE 13 Experimental Treatment 1 Intervention

SHINE 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.

Group XIII: SHINE 12 Experimental Treatment 1 Intervention

SHINE 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.

Group XIV: SHINE 11 Experimental Treatment 1 Intervention

SHINE 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.

Group XV: SHINE 10 Experimental Treatment 1 Intervention

SHINE 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.

Group XVI: SHINE 1 Experimental Treatment 1 Intervention

SHINE 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Findings from Research

In a study involving 75 women with breast cancer, both the PLISSIT model and Grouped Sexuality Education (GSE) significantly improved self-reported sexual behaviors after 6 and 12 weeks, indicating their efficacy in addressing sexual issues post-diagnosis.

GSE was found to be more effective than the PLISSIT model, suggesting it may be a better option for supporting the sexual health of women with cancer, especially in communities where these issues are often neglected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual health outcomes of PLISSIT-based counseling versus grouped sexuality education among Iranian women with breast cancer: A randomized clinical trial. Khoei, EM., Kharaghani, R., Shakibazadeh, E., et al.[2023]

Over the first 18 months post-breast cancer diagnosis, the percentage of partnered women who reported being sexually active increased from 52.4% to 60.7%.

Factors such as age, past chemotherapy, depressive symptoms, and perceived attractiveness were linked to sexual inactivity, with sexually inactive women experiencing more sexual problems, highlighting the need for healthcare providers to address sexual health in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual functioning among early post-treatment breast cancer survivors. Avis, NE., Johnson, A., Canzona, MR., et al.[2019]

The iSHARE intervention, which trained breast cancer clinicians to communicate about sexual health concerns, was feasible and well-accepted, with 88% participation from the enrolled clinicians.

Post-intervention, clinicians showed increased self-efficacy and improved communication behaviors regarding sexual health, although patient satisfaction and the duration of these discussions remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief intervention to enhance breast cancer clinicians' communication about sexual health: Feasibility, acceptability, and preliminary outcomes. Reese, JB., Lepore, SJ., Daly, MB., et al.[2020]

In a trial involving 60 female cancer survivors, an online self-help intervention significantly increased the number of sexually active participants at follow-up, indicating its potential effectiveness in improving sexual function (p < 0.001).

Participants also reported improved sexual function and increased use of sexual aids, suggesting that the intervention can positively impact sexual health, although high attrition rates highlight the need for better patient engagement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness trial of an online self-help intervention for sexual problems after cancer. Schover, LR., Strollo, S., Stein, K., et al.[2021]

A systematic review of 14 couple-based intervention studies from 2009 to 2016 found that these interventions, which addressed sexuality issues after cancer, varied widely in structure, delivery methods, and session duration, indicating a lack of standardization in the field.

Despite the diversity in approaches, the review highlights the need for improved research quality and clearer outcome measures to better inform clinical practices for addressing sexuality-related problems in cancer survivors and their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of characteristics of couple-based intervention studies addressing sexuality following cancer. Jonsdottir, JI., Jonsdottir, H., Klinke, ME.[2018]

A survey of 220 female cancer survivors revealed that common sexual health issues included pain during intercourse (87.2%), vaginal dryness (85.3%), and low libido (82.6%), with menopausal women experiencing these issues more frequently.

The majority of participants adhered to recommended therapies, such as vaginal moisturizers and lubricants (96.9-100%), and reported significant improvements in their sexual health, with 92% feeling more informed and 91% willing to recommend the program to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. Rash, JK., Seaborne, LA., Peterson, M., et al.[2023]

Online interventions for cancer patients' sexual health have shown significant improvements in sexual function and interest, as well as addressing psychological aspects of sexual problems.

The review of four studies indicates that these interventions effectively combine education, interactive methods, and cognitive behavior therapy to support both cancer survivors and their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online-based interventions for sexual health among individuals with cancer: a systematic review. Kang, HS., Kim, HK., Park, SM., et al.[2018]

A 12-week online psychoeducational program significantly improved sexual function, sex-related distress, and mood in women cancer survivors, with benefits lasting up to six months after the program ended.

While men showed some improvement in intercourse satisfaction, their overall sexual desire did not significantly change, indicating a need for more tailored interventions for male survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. Brotto, LA., Dunkley, CR., Breckon, E., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Sexual health outcomes of PLISSIT-based counseling versus grouped sexuality education among Iranian women with breast cancer: A randomized clinical trial. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Sexual functioning among early post-treatment breast cancer survivors. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A brief intervention to enhance breast cancer clinicians' communication about sexual health: Feasibility, acceptability, and preliminary outcomes. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness trial of an online self-help intervention for sexual problems after cancer. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review of characteristics of couple-based intervention studies addressing sexuality following cancer. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Online-based interventions for sexual health among individuals with cancer: a systematic review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. [2018]