Mind-Body Intervention for Sexual Dysfunction in Breast Cancer Survivors

Overseen By Pearman D Parker, PhD, MPH, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Must be taking: Hormonal therapies

Disqualifiers: Advanced breast cancer, no internet, others

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

Compensation: Varies

Number of Visits: 9

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young women who have survived breast cancer improve their sexual health and body image. It tests an 8-session nurse-led program called EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience), delivered online to determine its effectiveness in reducing menopausal symptoms and improving sexual functioning. Women who have undergone breast cancer treatments like chemotherapy or radiation in the last five years, are on certain hormonal therapies, and are in a relationship might be suitable candidates. Participants will receive tools such as vaginal rehydration and lubrication products and can earn up to $150 in gift cards. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for breast cancer survivors.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, participants must be on hormonal therapies like aromatase inhibitors or tamoxifen.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on hormonal therapies like aromatase inhibitors or tamoxifen, so you may need to continue those.

What prior data suggests that this intervention is safe for breast cancer survivors?

Research has shown that nurse-led programs can improve sexual health after breast cancer. One study on sexual wellness found that sessions led by nurses specializing in cancer care benefited breast cancer survivors. These private sessions address sexual problems that many women experience after breast cancer.

The EMBRACE program includes educational sessions and products such as vaginal moisturizers, dilators, and lubricants. These products are commonly used and generally safe. Similar situations have reported no serious side effects from these products.

Overall, the combination of education and these products aims to safely enhance sexual health and well-being for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for sexual dysfunction in breast cancer survivors, which often rely on medication or surgery, the EMBRACE intervention focuses on a holistic approach combining mind and body techniques. Researchers are excited about this intervention because it involves personalized sessions with a nurse certified in sexuality and sex education, providing both emotional support and practical solutions. Participants receive tools for vaginal rehydration, dilation, and lubrication, which are mailed directly to them, offering convenience and accessibility. This approach not only addresses physical symptoms but also empowers survivors to reclaim their sexual health and well-being, distinguishing it from more conventional treatments.

What evidence suggests that the EMBRACE intervention is effective for improving sexual functioning in breast cancer survivors?

Research has shown that many breast cancer survivors experience sexual problems, affecting over 60% of women. These issues can persist for years after treatment. The EMBRACE program in this trial aims to address these problems using a mind-body approach. Early evidence suggests that focusing on both mental and physical aspects can improve sexual function and body image. The program includes tools like vaginal moisturizers and exercises, which have been used to manage menopause symptoms and enhance sexual health. These components are designed to help women regain their sexual health after cancer. Participants in this trial will be randomized into either the EMBRACE Group or the Delayed EMBRACE Group to evaluate the program's effectiveness. ^{1 4 6 7 8}

Who Is on the Research Team?

Pearman D Parker, PhD, MPH, RN

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for young women aged 18-50 who were diagnosed with breast cancer stages I-III, have finished active treatment within the last five years, can communicate in English, and are currently in a relationship. They must be able to talk privately online and be on hormonal therapies like aromatase inhibitors or tamoxifen.

Inclusion Criteria

I was diagnosed with breast cancer at stages I-III and was between 18-50 years old at diagnosis.

Currently partnered (i.e., in a relationship)

I finished my cancer treatment within the last 5 years.

Exclusion Criteria

Women without access to the internet

I cannot read or speak English.

I am currently receiving chemotherapy or radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a nurse-led psychoeducational intervention for sexual health over 8 sessions

16 weeks

8 sessions (virtual)

Follow-up

Participants complete surveys to assess the impact of the intervention on sexual health and body image

6 weeks

Surveys at Week 1, Week 16, and Week 22

What Are the Treatments Tested in This Trial?

Interventions

• EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience)

Trial Overview The EMBRACE intervention is being tested to see if it helps improve sexual health after breast cancer. It's an online nurse-led program focusing on sexual functioning, menopausal symptoms, and body image over eight sessions across 16 weeks.

How Is the Trial Designed?

Group I: EMBRACE Group Experimental Treatment 1 Intervention

Immediately following consent, participants randomized to the EMBRACE Group will begin with the EMBRACE intervention. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.

Group II: Delayed EMBRACE Group Active Control 1 Intervention

After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 16 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Intimate Pathways, LLC

Collaborator

Trials

1

Recruited

40+

Intimate Pathways Center for Sexual Health

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Internet-based cognitive behavioral therapy (CBT) significantly improved sexual satisfaction, intimacy, and relationship satisfaction for partners of breast cancer survivors, based on a study of 69 participants.

While the CBT program primarily targeted the sexual health of breast cancer survivors, it is suggested that future programs should also focus on the partners' needs to enhance overall sexual functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Functioning and Relationship Satisfaction of Partners of Breast Cancer Survivors Who Receive Internet-Based Sex Therapy. Hummel, SB., van Lankveld, JJDM., Oldenburg, HSA., et al.[2019]

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]

The couple-based Intimacy Enhancement (IE) intervention, delivered via telephone to 29 breast cancer survivors and their partners, was found to be feasible and acceptable, indicating it could be a valuable resource for addressing sexual concerns post-treatment.

The IE intervention showed medium to large positive effects on sexual and psychosocial outcomes for survivors, suggesting it effectively enhances intimacy and well-being, although the impact on relationship outcomes was less pronounced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot trial of a couple-based intervention addressing sexual concerns for breast cancer survivors. Reese, JB., Smith, KC., Handorf, E., et al.[2020]

Internet-based cognitive behavioral therapy (CBT) significantly improved sexual functioning in breast cancer survivors, with notable increases in sexual desire, arousal, and lubrication over a 24-week period, compared to a control group.

The intervention also positively affected body image and reduced menopausal symptoms, indicating that Internet-based CBT can be an effective therapeutic option for addressing sexual dysfunction in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Cognitive Behavioral Therapy in Improving Sexual Functioning of Breast Cancer Survivors: Results of a Randomized Controlled Trial. Hummel, SB., van Lankveld, JJDM., Oldenburg, HSA., et al.[2022]

Sexual dysfunction is a prevalent issue among breast cancer survivors due to treatment-induced hormonal changes, highlighting the need for regular sexual assessments by healthcare providers.

The review emphasizes the importance of using various assessment tools to identify sexual dysfunction in breast cancer survivors, which can significantly improve their quality of life and that of their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Survivors and Sexuality: A Review of the Literature Concerning Sexual Functioning, Assessment Tools, and Evidence-Based Interventions. Dow, J., Kennedy Sheldon, L.[2017]

Psychological interventions significantly improve sexual function, satisfaction, relationships, and reduce sexual distress in women with breast cancer, based on a systematic review of 15 studies involving 1307 participants.

Cognitive behavioral therapy and psychoeducational therapy were particularly effective, highlighting the importance of these approaches in enhancing sexual health for women undergoing treatment for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions for sexual function and satisfaction of women with breast cancer: A systematic review and meta-analysis. Xu, J., Xue, B., Li, L., et al.[2023]

A 6-week psycho-educational group intervention for breast cancer survivors showed modest improvements in relationship adjustment and sexual satisfaction, particularly benefiting those who were least satisfied with their sexual relationships.

While the intervention did not significantly change emotional functioning compared to the control group, it highlights a potential approach for addressing ongoing intimacy issues in breast cancer survivors, which can be implemented in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing intimacy and partner communication after breast cancer: a randomized controlled group intervention. Rowland, JH., Meyerowitz, BE., Crespi, CM., et al.[2021]

A study of 31 breast cancer survivors who declined participation in a couple-based Intimacy Enhancement intervention revealed that the main reasons for refusal were time commitment (74%) and lack of partner interest (32%).

Most participants expressed a desire for their partners to be involved in addressing sexual concerns, with a preference for resources like informational websites (45%) and professional meetings (26%), suggesting that more flexible and brief intervention formats could improve participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why do breast cancer survivors decline a couple-based intimacy enhancement intervention trial? Reese, JB., Sorice, KA., Oppenheimer, NM., 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 study involving 31 women who underwent breast cancer surgery showed that acceptance and commitment therapy-based psychoeducation significantly improved body image, sexual quality of life, and dyadic adjustment after the intervention.

The improvements were measured using validated scales, indicating that this type of psychoeducation can be an effective part of nursing care for enhancing the well-being of women post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Acceptance and Commitment Therapy-Based Psychoeducation on Body Image, Quality of Sexual Life, and Dyadic Adjustment of Women After Breast Cancer Surgery. Tunç, E., Sevcan Orak, O., İşeri, Ö.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10937197/

Investigating sexual health after breast cancer by ... Nearly 78.1% among 7895 patients reported at least one sexual concern between diagnosis and 4 years' follow-up. Over time, the proportion of ...

2. researchgate.net researchgate.net/publication/258192220_Sexual_Health_and_Well-Being_After_Cancer_Applying_the_Sexual_Health_Model

(PDF) Sexual Health and Well-Being After Cancer Applying ... Sexual dysfunction is a common and often persistent complication for cancer survivors, affecting >60% of women diagnosed with cancer. Although ...

3. apm.amegroups.org apm.amegroups.org/article/view/128988/html

Sexual health after breast cancer: a clinical practice review [2022], found that the risk of sexual dysfunction increased 3.5-fold among BC survivors compared to women with other forms of cancer (4).

4. jons-online.com jons-online.com/issues/2024/november-2024-vol-15-no-11/reclaiming-intimacy

Reclaiming Intimacy: Exploring the Impact of Cancer on the ... Altered sexuality and intimacy are among the top quality-of-life issues cited by cancer survivors posttreatment, according to Sage Bolte, PhD, LCSW, Chief ...

5. mdpi.com mdpi.com/2077-0383/11/22/6723

Sexual Health after a Breast Cancer Diagnosis In this article, we review the contributing factors, screening, and management of sexual difficulties in cisgender female breast cancer survivors.

6. scielo.br scielo.br/j/rbcan/a/BTPfySSfBQtCkw9DfbGdFBG/?lang=en&format=pdf

Sexuality and Psychological Well-Being in Breast Cancer ... Incidence and severity of sexual dysfunction among women with breast cancer: a meta-analysis based on female sexual function index. Support Care Cancer.

7. cancer.uams.edu cancer.uams.edu/clinical-trial/improve-sexual-health-in-breast-cancer-survivorship/

Improve Sexual Health in Breast Cancer Survivorship A nurse-led study about sexual wellness in survivorship. We will offer private one-on-one sessions with an Oncology Sexual Health Specialist Registered Nurse.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6297963/

Management of sexual dysfunction in breast cancer survivors Female sexual dysfunction occurs frequently in midlife breast cancer survivors (BCS) and encompasses problems with sexual desire, interest, arousal, orgasm and ...