Online Sexual Health Program for Breast Cancer Survivors

(SHINE Trial)

Recruiting in Palo Alto (17 mi)

+246 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Planned cancer treatment, Serious mental illness, Pregnancy, others

No Placebo Group

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.

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.

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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.

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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.

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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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Illinois CancerCare-Kewanee Clinic Kewanee, IL

Hennepin County Medical Center Minneapolis, MN

Fairview Lakes Medical Center Wyoming, MN

Holy Name Hospital Teaneck, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences Lead Sponsor

National Cancer Institute (NCI) Collaborator

University of Virginia Collaborator

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] In-person, individual counseling using the PLISSIT model is a well-known approach to help people with sexual problems. Evidence suggests that Grouped Sexuality Education (GSE) can be as effective as in-person sexuality education. The efficacy of PLISSIT versus GSE has not previously been evaluated in women with Breast Cancer (BC). In this paper, we report on the effect of PLISSIT versus GSE on self-reported sexual behaviors experienced by women after a BC diagnosis (n = 75). The women were randomly allocated into three groups, with 25 women in each arm. Data analysis of the intention-to-treat population (n = 65) revealed efficacy of both GSE and PLISSIT in improving sexual behaviors (p < 0.0001) with a positive change in sexual capacity, motivation and performance after 6- and 12-weeks post-intervention follow ups. We found the GSE model showed a greater efficacy than the PLISSIT model. Due to the substantial needs faced by women with cancer and the cost associated with implementing the PLISST model, GSE seems to be more effective. We recommend GSE for Iranian communities where management of sexual problems is at an early stage and where the sexuality of women with cancer is routinely overlooked.

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

Sexual functioning among early post-treatment breast cancer survivors. [2019] This study aims (1) to estimate percentages of partnered women who are sexually active over the first 2 years post-breast cancer diagnosis; (2) to identify factors related to sexual inactivity; and (3) to evaluate separately, among both sexually active and inactive survivors, the relation between sexual problems and treatment-related variables, symptoms, and psychosocial factors.

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] Sexual concerns are often unaddressed for breast cancer patients; one reason is inadequate clinician training. We examined the feasibility, acceptability, and potential benefits of a novel intervention, improving Sexual Health and Augmenting Relationships through Education (iSHARE) for breast cancer clinicians.

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

Effectiveness trial of an online self-help intervention for sexual problems after cancer. [2021] Sexual dysfunction affects over 60% of cancer survivors. Internet interventions have improved sexual function, but with considerable clinician guidance, restricting scalability. This pragmatic trial evaluated an online, self-help intervention. As with many unguided digital interventions, attrition was high. Given low numbers in other groups, this paper focuses on 30% of female patient participants who completed 3-month questionnaires and visited the intervention site (N = 60). Benefits included increased sexually active individuals at follow-up (p

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

A systematic review of characteristics of couple-based intervention studies addressing sexuality following cancer. [2018] To describe the characteristics of couple-based intervention studies that address sexuality following cancer.

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] Sexual health concerns are common among female cancer survivors. Few data exist regarding patient-reported outcomes following interventions in this population. We aimed to determine patient-reported adherence and impact of interventions provided in an academic specialty clinic for treatment of sexual health problems.

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

Online-based interventions for sexual health among individuals with cancer: a systematic review. [2018] Online interventions have the advantages of being widely available, accessible, comfortable, cost effective, and they can provide tailored information and support. Despite these benefits, the effects of specifically devised online intervention programs for cancer patients' sexual problems are somewhat unclear. The aim of this review is to describe online-based interventions and to assess their effects on sexual health among cancer survivors and/or their partners.

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] Sexual health is an integral component of quality of life for cancer survivors, and is often negatively impacted by treatment. Geographic limitations often prohibit survivors from accessing sexual health programs designed to address their needs. This study examined the efficacy of an online, 12-week psychoeducational program, which included elements of mindfulness meditation, for sexual difficulties in survivors of colorectal or gynecologic cancer. Complete pre- and postintervention data were available for 46 women (mean age 55.0, SD 9.6) and 15 men (mean age 59.7, SD 6.8). Women experienced significant improvements in sex-related distress (p