← Back to Search

Behavioral Intervention

Mind-Body Intervention for Sexual Dysfunction in Breast Cancer Survivors

N/A

Recruiting

Led By Pearman D Parker, PhD, MPH, RN

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with breast cancer (stages I - III) between ages 18 - 50

On hormonal therapies (aromatase inhibitors, tamoxifen)

Must not have

More than five years have passed since completing active treatment (chemotherapy and/or radiation)

History of advanced breast cancer (stage IV) or a breast cancer recurrence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, week 16, week 22

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a nurse-led program to help young women who are breast cancer survivors with their sexual health. The trial will look at whether the program can be done online and in private, and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a psychoeducational intervention rather than a drug treatment, there may not be physical side effects. Participants might experience emotional discomfort discussing personal topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am currently on hormone therapy for cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

It has been over 5 years since I finished my chemotherapy or radiation.

Select...

I have had advanced (stage IV) breast cancer or a recurrence.

Select...

I cannot read or speak English.

Select...

I am currently receiving chemotherapy or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, week 16, week 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1, week 16, week 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 16, week 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Image Scale

Female Sexual Functioning Index

Vulvovaginal Symptoms Questionnaire (VSQ)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EMBRACE GroupExperimental Treatment1 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 GroupActive Control1 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.

0 / 6Eligibility criteria met