Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Breast Neoplasms

Premature Birth

Primary Ovarian Insufficiency

Menopause, Premature

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Breast Diseases

Skin Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Menopause

Pharmaceutical Solutions

All Drugs and Chemicals

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 once weekly for 8 - 10 weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. 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.

After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 8 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education once weekly for 8 - 10 weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. 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.

The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills.

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

Pearman D Parker, PhD, MPH, RN

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 8 - 10 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.

Participant eligibility is based on gender at birth.

Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors

Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women

A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.

A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment.

A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.

Intimate Pathways Center for Sexual Health

University of Arkansas

Behaviors and Mental Disorders

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Quality of Life

Participants who are treated with radiation therapy: Questionnaires 5 times.

Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Questionnaire

Diane C. Bodurka, MD

Objectives:

Primary Objectives:

To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity, dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; To assess general cancer-related QOL over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; To characterize the relationship between sexual dysfunction and overall cancer-related QOL over time; and To identify factors that may predict better sexual function outcomes in patients treated for cervical cancer.

Secondary Objectives:

Describe vaginal changes objectively via measurement of vaginal length. Demonstrate reliability of the vaginal length instrument and its applicability to future studies.

There are two parts to this study. The first part is called a "feasibility study" and will include 20 women who have been treated for cervix cancer in the past. These women will be asked to fill out questionnaires to evaluate their quality of life and sexual functioning. The questionnaires will only be completed once. The questionnaires will be filled out during routine clinic visits.

If the feasibility study is successful (if the majority of the 20 women are able to complete the questionnaires), the second part of the study will be performed with a larger number of women who have been diagnosed with cervix cancer but who have not yet begun treatment. Patients who participate in this part of the study will also be asked to fill out the questionnaires described above.

Participants who are treated with radiation therapy will be asked to complete questionnaires 5 times: before radiation treatment starts, at the time of the first ALTO, and 1 month, 4 months and 7 months after treatment ends. Vaginal measurements will only be done 4 times: at the time of first ALTO, and 1 month, 4 months and 7 months after treatment ends.

Participants who undergo a radical hysterectomy will be asked to complete questionnaires and have a vaginal measurement 4 times: before surgery and 1 month, 4 months and 7 months after treatment ends. Vaginal measurements will only be done 4 times: at the time of first ALTO, and 1 month, 4 months and 7 months after treatment ends.

The questionnaires take about 20 minutes to complete. The vaginal measurement is done by a doctor and takes less than a minute to complete.

This is an investigational study. About 165 patients will take part in this multicenter study. About 135 patients will be enrolled at M. D. Anderson.

Sexual Functioning in Cervical Cancer Survivors

Sexual Functioning and Quality of Life in Women With Cervical Cancer

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Carcinoma, Adenosquamous

Radical trachelectomy outcomes for cervical cancer

5 Questionnaires at differing times before and after surgery.

Questionnaires

Michael M. Frumovitz, MD

The goal of this research study is to learn about quality of life, sexual functioning, and symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer.

This is an investigational study.

Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Before Surgery:

If you agree to take part in this study, before you have the abdominal radical trachelectomy surgery, the following information will be recorded during one of your regular clinic visits:

* Your race and date of birth.
* Your complete medical and surgical history, including the date of your diagnosis and your diagnosis before surgery.
* Your weight, height, and body mass index.

During and After Surgery:

During and after surgery, the following information will be gathered from your medical record or you will be asked:

* If there was any blood loss during surgery.
* How long the surgery lasted.
* If there were any complications during the surgery.
* If you needed any blood transfusions.
* What type of instrument was used for preventing or sealing blood loss.
* How long you stayed in the hospital.
* If you experienced any infections within 1 month after surgery.
* If you experienced any complications within 1 month or later than 1 month after surgery.
* The length of time it took to recover your bowel and urinary function.
* If you received any treatments for cancer after surgery, such as radiation therapy, chemotherapy, or hormonal therapy.

Once a year for up to 5 years, if you return for an annual routine follow up visit, the results of any pap smears you have had will be collected.

Once a year for up to 5 years, you will also be asked the following questions about your health and fertility, either by mail or during a regular clinic visit:

* What is the status of the disease?
* Did you want to get pregnant in the last year?
* Did you attempt to get pregnant?
* Did you become pregnant? If so, how you became pregnant and the outcome of the pregnancy? If not how long did you try to become pregnant and did you try any form of assisted reproduction?

Questionnaires:

You will complete 4-5 questionnaires at each of the following times:

* Within 2 weeks before your surgery.
* At 4-6 weeks after surgery
* At 6 months after surgery.
* At 1 year after surgery.
* Once a year for the next 4 years.

These questionnaires will ask about your physical health, mental and emotional health, pain, vitality, social functioning, general health, quality of life, and sexual functioning. It will take about 15 minutes to complete 5 questionnaires. If you do not receive your follow-up care at MD Anderson, the questionnaires will be mailed to you at the above time-points with a prepaid return envelope. Mailed questionnaires will be returned to the study chair in an envelope marked CONFIDENTIAL with NO RETURN ADDRESS on the return envelope. Your name will not appear on the questionnaires or return envelope. Instead, a code will be used (on the questionnaires only) that will connect the questionnaires with your medical record. Only the study chair or study coordinator will have access to the code document. The document is kept in a locked filing cabinet and/or password protected computer. All responses will be stored in a locked office.

Length of Study:

You will be on study for up to 5 years. If the disease returns, you will be taken off study.

Radical Trachelectomy for Women With Early Stage Cervical Cancer

Completed SF-12 questionnaires at baseline and at each follow-up visit (4-6 weeks, 6 months, 1 year, and annually for 4 more years)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors	NCT06307470	Women's Health:... Menopause, Prem... Body Image Sexual Dysfunct... Cancer, Breast	EMBRACE (Empowe...	18 Years - 50 Years	University of Arkansas
Sexual Functioning in Cervical Cancer Survivors	NCT00522223	Cervical Cancer	Questionnaire	-	M.D. Anderson Cancer Center
Sexual Functioning in Cervical Cancer Survivors	NCT00522223	Cervical Cancer	Questionnaire	-	M.D. Anderson Cancer Center
Radical Trachelectomy for Women With Early Stage Cervical Cancer	NCT00813007	Cervical Cancer	Questionnaires	18 Years - 40 Years	M.D. Anderson Cancer Center
Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors	NCT06307470	Women's Health:... Menopause, Prem... Body Image Sexual Dysfunct... Cancer, Breast	EMBRACE (Empowe...	18 Years - 50 Years	University of Arkansas

Spots Global Cancer Trial Database for sexual functioning