Feasibility of a Factorial Design
Research Purpose:
This study was developed for women seeking to improve their sexual health after breast cancer treatment who are open to using a vaginal moisturizer and possibly listening to hypnotic relaxation or progressive muscle relaxation recordings.
Breast cancer treatment can contribute to vaginal dryness and changes in body image and sexual desire. The WISH multi-component research study is being conducted to determine if it is possible to address multiple aspects of sexual health with one or two interventions. This is the second WISH study, which builds on the first by adding an additional type of vaginal moisturizer and an additional relaxation intervention.
Importance:
Diminishing sexual function is one of the long-term effects most strongly linked by evidence to cancer diagnosis and treatment. Related symptoms are often accompanied by distress as the desire to “get back to normal” increases post treatment. Research has shown that interventions addressing sexual function can help women improve their sexual health following cancer.
Time Commitment:
- 1 virtual consent and baseline visit with surveys (60 min)
- 1 virtual education visit after 2 weeks (30 min)
- Once every 3 days, use vaginal moisturizer
- 3 self-hypnosis or progressive muscle relaxation sessions per week possible, depending on study
arm (20 min sessions, 3x/week for 6 weeks, total possible = 6 hours) - Bi-weekly phone check-in calls weeks 4 and 6 (20 min each)
- 1 virtual end of study visit at the end of week 8 (45 min)
- Surveys week 8 (15 min)
Compensation:
Participants will be compensated for their participation in this research study and may receive a total of up to $75 in the form of gift cards. Compensation will be prorated at $25 for each two week period which includes completion of data, check-in phone calls and AE assessments.
Eligibility: To participate, you must:
- Be female, at least 18 years old with a history of any stage of breast cancer.
- Be able to read and write English
- Have a history of any stage of breast cancer
- Have completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3months and ≤ 10 years prior to registration
- Have a current sexual partner and be able to engage in sexual activity
- Be experiencing vaginal or vulvar dryness and/or pain with sexual activity
- Be experiencing negative changes in body image or sexual desire since being diagnosed or treated for cancer
- NOT have an active psychiatric disorder that is causing you symptoms of distress such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, schizophrenia, PTSD or borderline personality disorder.
- NOT be using oral, transdermal or vaginal estrogen
- NOT be enrolled in another study that addresses sexual health.
- NOT have an allergy or intolerance to Replens, HYALO GYN or any of their components.
This is active but is no longer enrolling participants.
More studies will be added as they become available. If you have questions about participating in the WISH Multicomponent Research Study, complete the form below and a member of our study team will be in touch.
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