Neoplasms

Digestive System Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Rectal Neoplasms

Sexual Dysfunction, Physiological

Fecal Incontinence

Urinary Incontinence

Enuresis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients randomized to the exercise training group will be individually instructed in correct pelvic floor muscle contractions and intensive pelvic floor muscle training to perform daily. In addition they will be encouraged to exercise regularly ≥3 days/week. The exercise program will be individualized and consisting of both aerobic and strength exercise training.

Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training

Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.

Exercise training

Usual care

Siri Forsmo, PhD, MD

Cancer treatments often cause acute toxicity during treatment, and late toxicity after treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction are late side effects associated with cancer treatment in general, and patients treated for pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329 in 2010. Advances in the treatment during the past few decades have led to fewer local recurrences and increased long-term survival, and today the relative survival is 66% for women and 64% for men. More patients are having sphincter-preserving surgery with low colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70% of the patients with curative surgery. Unfortunately, many patients experience altered bowel function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal incontinence are common and distressing complications. These functional disturbances are seen in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant therapy. Urinary incontinence and decreased sexual function is also common in both men and women following rectal cancer treatment.

In many surgical settings, patients with higher preoperative physical fitness rehabilitate more quickly and have fewer operative complications compared with patients who are less physically fit. Additionally, specific strength training of the pelvic floor muscles builds up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and closes the levator hiatus thus providing improved structural support for the pelvic floor as well as more optimal automatic function. The aim of the present trial is to investigate whether exercise training including pelvic floor muscle training during preoperative radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the physiology of the anal sphincter muscle after LAR. In addition quality of life, cardiopulmonary parameters and postoperative complications will be studied.

Exercise Training for Rectal Cancer Patients

Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.

International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)

Low anterior resection syndrome score (LARS)

The International Index of Erectile Function (IIEF) for men and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) (PISQ-IR) for women

The European Organization for Research and Treatment of Cancer Quality of Life core questionnaire (EORTC QLQ-C30) and the colorectal cancer specific Quality of Life Questionnaire (QLQ-C38).

International Statistical Classification of Diseases and Related Health problems, 10th revision (ICD-10) diagnostic codes, from the patient records

Activity monitor (SenseWear) to measure level of daily physical activity

Number of days in hospital from the patient records

St. Olavs Hospital

Norwegian University of Science and Technology

Skin and Connective Tissue Diseases

Atrophy

Breast Neoplasms

Genital Diseases

Urogenital Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Central Nervous System Depressants

Herbal and Botanical

Other Dietary Supplements

Psyllium

Calcium polycarbophil

Mineral Oil

Dehydroepiandrosterone

Hypnotics and Sedatives

DHEA (Dehydroepiandrosterone)

Passionflower

The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis.

The vaginal moisturizer component of this arm is the same as that described for the VVA study arm.

This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers.

HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)

Hypnotic Relaxation Intervention (HRI)

VVA is a standard of care intervention (Replens™ vaginal moisturizer device)

Vulvovaginal Atrophy (VVA)

Debra L Barton, PhD,RN,FAAN

The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast cancer. Our team is developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vulvovaginal tissue quality and symptoms, desire/energy, and relationship-partner concerns. This proposal begins the proof-of-concept pilot study in women with a history of breast cancer to deliver a multi-component intervention to improve vulvo-vaginal atrophy with a vaginal moisturizer, and sexual energy and self-image with a mind-body intervention that involves relaxation and subconscious suggestions with a hypnotic induction delivered via audio file. The primary outcome will be to evaluate the feasibility and acceptability of a multi-component intervention for sexual function. It is hypothesized that at least eighty percent of randomized participants will complete the study without differential withdraws from the control group.

Women's Interventions for Sexual Health (WISH), is a two-arm randomized clinical trial to evaluate the feasibility and acceptability of a multi-component intervention addressing changes in body image, sexual desire, and vaginal dryness in thirty adult post-treatment breast cancer survivors. The study is eight weeks long and does not require any in-person visits. If a breast cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, they will be emailed the consent form and will schedule a virtual consent/baseline visit. After consent is obtained, the participant will be randomly assigned to a study arm, HRI (hypnotic relaxation intervention plus vaginal moisturizer) or VVA (vulvovaginal atrophy moisturizer only), given a study number, and educated on the use of Replens™ vaginal moisturizer. The participant will complete online surveys at the virtual baseline visit. Replens™ vaginal moisturizer will be sent to the participant's address and receipt of the moisturizer will be confirmed by study staff before the agreed upon week one start date. The participant will use the moisturizer every day during weeks one and two and every other day during weeks three through eight. Participants randomized to the HRI group will also receive an MP3 player with three hypnotic relaxation audio files and asked to complete a weekly practice log. Each hypnotic induction audio file will be used for two weeks, three times per week, for a total of six weeks of hypnosis. A second virtual visit will be held at two weeks to assess progress, adverse events and provide education to the HRI group. Check in phone calls will be scheduled for weeks four, six and eight. A link to online follow up surveys will be shared during weeks six and eight.

This is a two-arm, randomized clinical trial.

Women's Interventions for Sexual Health: WISH

Women's Interventions for Sexual Health: WISH, A Pilot Study

This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data sharing requests for deidentified data as appropriate.

The number of participants who consented divided by the number eligible

The number of participants who complete the 8 weeks of the study divided by the number who consented.

Breast Cancer Research Foundation

The University of Tennessee, Knoxville

McMahan-McKinley Endowed Professor of Gerontology

This will consist of still vaginal dilator and/or lubricant.

The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

Vaginal Renewal Program

Vaginal Dilator

David M Kushner, MD

This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers.

In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP).

Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.

Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction

Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial

Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.

The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale:

0 = no pain with intercourse

1. = pain with intercourse that doesn't prevent the completion
2. = pain with intercourse requiring interruption or discontinuance
3. = pain with intercourse preventing any intercourse

Difference in Marinoff scores reported, value at 6 months minus value at baseline.

The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported.

Change in vaginal length as measured from baseline to 6 months.

University of Wisconsin, Madison

Participants were assessed for toxicity at each study visit. All events at least possibly related to the study intervention will be collected. Participants were instructed to call the study team for adverse events that occurred between visits. The study team or an on-call physician were available 24 hours a day.

Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Standard of Care

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Prior Pelvic Radiation

No Prior Pelvic Radiation

Pelvic Radiation

Ovary

Endometrium

Cervix

Vulva

Dual Primary (Ovary and Endometrium)

Primary Disease Site

The study was closed before completion due to a slowing accrual rate.

Dr. David Kushner

Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months

Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.

Change in Marinoff Scale at 6 Months

FACT-G Score

Vaginal Length

Overall Study

Urinary Bladder Neoplasms

Erectile Dysfunction

Hematuria

Sexual Dysfunctions, Psychological

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Genital Diseases, Male

Mental Disorders

Psychotic Disorders

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urination Disorders

Hemorrhage

Questionnaires answered at baseline and 4 months follow up.

EORTC QLQ-C30 and EORTC BLS-24 questionnaire

Peter B Østergren, MD

The purpose of the study is to investigate sexual function in patients suspected of non muscle invasive bladder cancer (NMIBC). The investigators hypothesis is that reduced sexual function is underdiagnosed in patients with non-muscle invasive bladder cancer and that active examination and treatment may worsen the sexual function.

Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer

Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"

Change in erectile function measured by the Erection Hardness Scale

Herlev Hospital

No intervention

Sam Porter, PhD, RN

The aim of this survey study is to provide broad information as reported by cancer survivors and their intimate partners about both their sexual health and their experiences of care from the United Kingdom hospital cancer team, including their perspectives on factors that may hinder or help care. This information will be analysed and used to inform the questions asked in a separate, subsequent, qualitative study.

Caring for the Sexual Health and Wellbeing of Cancer Survivors and Their Intimate Partners: An Anonymous Survey

An Anonymous Survey Investigating Care for the Sexual Health of Cancer Survivors and Their Intimate Partners, as Provided by the United Kingdom Hospital Cancer Team

Participant information sheet stated that information would not be made publicly available via a data sharing repository. This approach was taken due to the sensitive nature of the topic and was anticipated to provide reassurance and potentially improve recruitment.

Sexual health discussion:19 examples of the sort of topics that may have been discussed in relation to sexual health

An online survey questionnaire (no validated questionnaire available and therefore research created the questionnaire based on a literature reviews on sexual health in oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exercise Training for Rectal Cancer Patients	NCT02538913	Rectal Neoplasm...	Exercise traini... Usual care	18 Years - 80 Years	Norwegian University of Science and Technology
Women's Interventions for Sexual Health: WISH	NCT05692960	Sexual Dysfunct... Body Image Libido; Loss, A...	Hypnotic Relaxa... Vulvovaginal At...	18 Years - 99 Years	The University of Tennessee, Knoxville
Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction	NCT01444911	Sexual Dysfunct...	Vaginal Renewal... Vaginal Dilator	18 Years -	University of Wisconsin, Madison
Exercise Training for Rectal Cancer Patients	NCT02538913	Rectal Neoplasm...	Exercise traini... Usual care	18 Years - 80 Years	Norwegian University of Science and Technology
Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer	NCT02381912	Urinary Bladder... Sexual Dysfunct... Sexual Dysfunct... Erectile Dysfun... Hematuria	EORTC QLQ-C30 a...	40 Years -	Herlev Hospital
Caring for the Sexual Health and Wellbeing of Cancer Survivors and Their Intimate Partners: An Anonymous Survey	NCT06074445	Cancer	No intervention	18 Years -	Bournemouth University

Spots Global Cancer Trial Database for sexual dysfunction, physiological