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

43 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are: 1. What is the feasibility of this intervention in an online, private setting? 2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image? Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 16 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.

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 data supports the idea that Mind-Body Intervention for Sexual Dysfunction in Breast Cancer Survivors is an effective treatment?

The available research shows that Mind-Body Intervention, specifically Internet-based cognitive behavioral therapy (CBT), significantly improves sexual functioning in breast cancer survivors. Participants in the CBT group experienced increased sexual desire, arousal, and pleasure, along with less discomfort and distress during sex compared to those who did not receive the treatment. Additionally, the intervention improved body image and reduced menopausal symptoms. While other treatments like the couple-based Intimacy Enhancement (IE) intervention also showed promise, the CBT approach had clear positive effects on sexual functioning and related aspects. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment EMBRACE for sexual dysfunction in breast cancer survivors?

Research shows that Internet-based cognitive behavioral therapy (CBT) significantly improves sexual functioning, body image, and reduces menopausal symptoms in breast cancer survivors. Additionally, a couple-based Intimacy Enhancement intervention demonstrated positive effects on sexual concerns and psychosocial well-being, suggesting that mind-body interventions can be effective for addressing sexual dysfunction in this population. ^{1 2 3 4 5}

What safety data exists for the Mind-Body Intervention for Sexual Dysfunction in Breast Cancer Survivors?

The provided research does not directly address the safety data for the Mind-Body Intervention or its variations like EMBRACE. The studies focus on the efficacy of different interventions, such as Internet-based cognitive behavioral therapy and psychoeducational programs, in improving sexual functioning and related outcomes in cancer survivors. However, they do not provide specific safety data for the Mind-Body Intervention or EMBRACE. Further research or specific studies on EMBRACE would be needed to determine its safety profile. ^{3 4 6 7 8}

Is the Mind-Body Intervention for Sexual Dysfunction in Breast Cancer Survivors safe?

The research articles reviewed do not provide specific safety data for the Mind-Body Intervention or its variations like EMBRACE. However, similar interventions, such as internet-based cognitive behavioral therapy and psychoeducational programs, have been studied without reported safety concerns, suggesting they are generally safe for participants. ^{3 4 6 7 8}

Is the treatment EMBRACE a promising treatment for sexual dysfunction in breast cancer survivors?

Yes, EMBRACE is a promising treatment for sexual dysfunction in breast cancer survivors. It focuses on improving sexual functioning, body image, and reducing menopausal symptoms, which are important for enhancing the quality of life for these survivors. ^{1 3 7 9 10}

How is the EMBRACE treatment different from other treatments for sexual dysfunction in breast cancer survivors?

The EMBRACE treatment is unique because it focuses on mind-body reclamation, empowering breast cancer survivors to address sexual dysfunction through a holistic approach that combines mental and physical well-being, unlike other treatments that may focus solely on psychological or physical aspects separately. ^{1 3 7 9 10}

Research Team

Pearman D Parker, PhD, MPH, RN

Principal Investigator

University of Arkansas

Eligibility Criteria

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.

I finished my cancer treatment within the last 5 years.

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

Exclusion Criteria

Women without access to the internet

I cannot read or speak English.

I am currently receiving chemotherapy or radiation.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized pilot trial of a couple-based intervention addressing sexual concerns for breast cancer survivors. [2020]

2. United States 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. [2023]

3. United States 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. [2022]

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

Why do breast cancer survivors decline a couple-based intimacy enhancement intervention trial? [2021]

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

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

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing intimacy and partner communication after breast cancer: a randomized controlled group intervention. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Sexual Functioning and Relationship Satisfaction of Partners of Breast Cancer Survivors Who Receive Internet-Based Sex Therapy. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Psychological interventions for sexual function and satisfaction of women with breast cancer: A systematic review and meta-analysis. [2023]