Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Patient receives standard pre-operative preparation which involves a discussion in to the likely aesthetic outcome with their surgeon or specialist nurse

Patient views photographs of women matched for BMI, age, and breast volume who are 1-5 years post BCT pre-operatively.

Patient pre-operatively views a simulation of their own breast of their likely outcome after BCT.

The viewing of a 3-dimensional simulation is classed as an intervention as it strays from the normal pre-operative preparation.

3-dimensional photograph with simulation

The viewing of a 2-dimensional photograph library is classed as an intervention as it strays from the normal pre-operative preparation.

Viewing of a 2-dimensional photographic library

Jennifer E Rusby, BMBS, MD

Amy R Godden, MBBS, BSc

Julie Curtis

Most women with breast cancer are able to have an operation to remove the cancer while preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most important goal, appearance of the breast after surgery has been shown to affect the quality of a woman's life after treatment. This is even more relevant now that most women are surviving breast cancer.

Before surgery, women are prepared for how they will look afterwards by having a discussion with the Surgeon or Breast Care Nurse. Sometimes women are shown two dimensional (2D) (standard) photographs of other women who had a similar operation. Patients have stated that viewing photographs of other patients does not prepare them adequately for their own experience of surgery.

Three dimensional (3D) digital photography is currently being used to predict the appearance of the breasts after enlargement surgery using specialist software. The investigators intend to use a similar system to simulate a patient's appearance after BCT for cancer. The investigators believe that this will lead women to feel better prepared for their surgery, reduce stress, and lead to greater satisfaction with their breast after treatment.

This study invites women undergoing BCT to be assigned at random to one of three groups receiving standard care (discussion), a 2D photograph, or the 3D simulation before their operation. The investigators will find out whether women feel better prepared for surgery and are more satisfied with their outcome if they are shown a simulated image of how their own breasts are likely to look.

By taking 3D photographs of all study patients before and after surgery, a more accurate way to predict appearance after surgery will be developed for future patients.

Women who are planning to have breast conserving therapy (BCT) (surgery and radiotherapy, BCT) will be identified via two pathways: 1) via the Multi-Disciplinary Team Meeting (MDM) or 2) the consulting clinician. At their surgical outpatient appointment, the patients will be given written information to take away and read at their convenience. After at least 24 hours a member of the study team will telephone the patient to answer any further questions and to see whether they would like to be considered for the trial. Women who wish to participate will have a face-to-face meeting arranged with one of the co-investigators.

At the face-to-face meeting the investigators will go through the study in detail and ask the participant to sign a consent form to allow themselves to be included in the trial. The investigators will make it clear that participants can withdraw at any point during the study. The investigators will answer any further questions, take a baseline 3-D surface image (this is done by a member of the study team in a closed room with a lockable door with the offer of a chaperone), and issue a BCT BREAST-Q.

BCT BREAST-Q is a questionnaire which has been designed for women with breast cancer who are undergoing BCT to look at their quality of life and satisfaction with different aspects of their treatment and outcome. It is split into two sections, one to be filled in before, and one after treatment.

At the face-to-face meeting, the participants will be randomly allocated into 3 groups by a computer so the study team are not involved in the decision. This makes sure the allocation is fair. All women will receive the standard care for BCT which involves a conversation with surgeon and specialist breast care nurse.

Group 1 will receive standard care only. Group 2 will be shown photographs of women who have had BCT by a member of the study team .

Group 3 will be shown a real time simulation of how their own breast is likely to look after BCT.

The preparation for group 2 and 3 will take place in a quiet closed room with the patient and co-investigator and a friend or relative if the patient wishes.

Next, the participants will be asked to complete a Visual Analogue Scale (VAS) which is a ten point scale ranging from worst-to-best (0-10) where the participant is asked to place a cross along the scale to rate their response to a specific question. The question "How confident are you that you know how your breasts are likely to look after treatment?" will be used at this point. This will conclude the face-to-face meeting. The investigators estimate the visit will take 30-40 minutes in total.

In summary thus far, after the face-to-face meeting all study participants will have given written consent, had a baseline 3D-SI, been randomised, received their appropriate preparation depending on the group allocation, have filled in a VAS for "How confident are you that you know how your breasts are likely to look after treatment?", and will have been issued with a BREAST-Q BCT questionnaire to fill out while they are waiting for randomisation or their simulation or to fill in at home and bring with them on the day of surgery.

The follow up plans will include 3D-SI, a further VAS for the question "How well do you think the information you were given about how your breasts are likely to look after surgery (discussion, 2D photographs, or 3D simulation) reflects how they actually look today?", and BCT BREAST-Q.

The 3D-SI will be taken at two weeks after their surgery (to coincide with the routine outpatient surgical appointment), before radiotherapy (to coincide with the first session of radiotherapy), 3 months after radiotherapy (to coincide with the routine radiotherapy out-patient check-up), 6 months after radiotherapy (this will need to be an additional appointment - parking charges will be refunded), at 12 months following treatment (to coincide with their normal follow-up mammogram appointment), and then annually for 5 years (to coincide with their routine mammogram appointments).

The BCT BREAST-Q will be administered at 3 and 12 months post radiotherapy (at the same time as the 3D-SI appointments above), and then annually for 5 years (at the routine mammography appointments).

The VAS for "How well do you think the information you were given before surgery about how your breasts are likely to look after surgery (discussion, 2D photographs, or 3D simulation) reflects how they actually look today?" will be administered at 3 and 12 months post treatment. The results from the VAS before treatment will be analysed to show whether there was a difference between treatment groups in participants' preparedness for surgery.

The results from the BCT BREAST-Q will show whether there was a difference between groups for how satisfied participants were with the information given to them about BCT, satisfaction with their breast, and overall quality of life during and after BCT.

The 3D-SIs taken after at 3 and 12 months post BCT will be used for comparison with the simulation model in order to improve and make it as realistic as possible. The investigators will use the 3D-SI at all time points to look at how the breasts change over time up until five years following BCT.

The post operative VAS will be used to see if the participants thought their preparation for treatment matched reality following BCT. The investigators used three groups in this study as simulation for BCT has never been done before so the investigators do not know what the best method of preparation will be. However, most hospitals do not have access to a 3D camera and it may be that much of the benefit in terms of patient preparation and confidence can be achieved by reviewing photographs which would be more generalisable within the NHS. Hence the investigators also need to compare standard care with being shown 2D photographs, and 2D with 3D.

The investigators will be working from one hospital (one of the biggest breast cancer centres in the UK) where 8 BCT operations per week are performed. When looking at how long it would take to recruit enough women for the study to make the results meaningful the investigators presumed that only half of the women approached would want to participate (less then our previous experience with similar trials which was more than three quarters). With this in mind the investigators calculated it would take 30 weeks to gather enough participants into the trial.

The trial will finish 5 years after the last participant has finished BCT.

Simulating Outcomes From Breast Conserving Surgery Using 3D Surface Imaging

The Use of 3D Surface Imaging to Simulate Outcome After Breast Conserving Therapy

The mean VAS (0-10mm) will be compared between groups at 3 and 12 months post treatment. The VAS will relate to the question: "How well do you think the information you were given before your surgery about how your breasts are likely to look after surgery (discussion, 2D photographs, or 3D simulation) reflects how they actually look today?"

Linear mammometrics will be compared between the simulation and the actual outcome captured on 3D-SI at 3 and 12 months in order to assess how accurate the simulation was to reality. All measurements will be represented as percentage change from the simulation to the post-operative 3D-SI (simulation/3D-SI x100).

Volume measurements will be compared between the simulation and the actual outcome captured on 3D-SI at 3 and 12 months in order to assess how accurate the simulation was to reality. All measurements will be represented as percentage change from the simulation to the post-operative 3D-SI (simulation/3D-SI x100).

Surface asymmetry measurements will be compared between the simulation and the actual outcome captured on 3D-SI at 3 and 12 months in order to assess how accurate the simulation was to reality. All measurements will be represented as percentage change from the simulation to the post-operative 3D-SI (simulation/3D-SI x100).

Skin colour values will be compared between the simulation and the actual outcome captured on 3D-SI at 3 and 12 months in order to assess how accurate the simulation was to reality. Colours values will be presented as absolute numbers (continuous data).

Linear mammometrics will be compared using 3D-SIs of the operated and non-operated breast over time. The measurements will be represented as percentage change over time.

Volumes will be compared using 3D-SIs of the operated and non-operated breast over time. The measurements will be represented as percentage change over time.

Surface asymmetry will be compared using 3D-SIs of the operated and non-operated breast over time. The measurements will be represented as percentage change over time.

Colour values will be compared using 3D-SIs of the operated and non-operated breast over time. The measurements will be represented as percentage change over time.

The mean VAS score (range: 0 -10mm) will be compared between groups. It is intended to assess preparedness for surgery of the women in each of the three arms. Patient scores in answer to the question "How confident are you that you know how your breasts are likely to look after treatment?" will be measured for each patient following randomisation and completion of their pre-operative preparation depending on study group.

The difference in mean BCT BREAST-Q 'satisfaction with information' domain scores will be compared between groups at 3 and 12 months post BCT. The mean of the 4 most relevant scales within the 'satisfaction with information' domain (6i-6l) will be compared between groups separately.

The mean difference between pre and post operative score for satisfaction with breasts will be compared between groups at 3 and 12 months.

The mean difference between pre and post operative score for 'quality of life' will be compared between groups at 3 and 12 months.

Royal Marsden NHS Foundation Trust

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients with prostate cancer were treated with 2D-radiotherapy

2D radiotherapy

Alessio G Morganti, MD

Prostate cancer (CAP) is one of the most common malignancies in men, both in Western countries and developing countries. Radiation therapy (RT) is an important therapeutic option. New technologies (3D, IMRT, IGRT, VMAT) have been introduced in the last decades, with a progressive improvement of clinical outcome. However, in many countries the only treatment option is the traditional 2D technique based on standard simulation. The indications for field definition in this treatment are still based on expert's opinions. The aim of this analysis is to propose new indications for 2D fields definition based on three-dimensional simulation in a population of patients with CAP. Twenty patients with CAP consecutively treated with RT in our center were identified. Patients underwent CT-simulation in supine position. Pelvic MRI images were fused with CT-simulation images. In this way, delineation of the prostate and seminal vesicles was performed on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP without involvement of the seminal vesicles, and high-risk CAP with involvement of seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV in all directions. For each patient, 8 treatment plans were calculated. In particular, for each of the 4 categories of risk, 2 treatment plans were calculated by using a cobalt source or 10 MV photons. Treatment plans were calculated using the box technique. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 \> 95%), distances of the fields edges from a set of reference points were measured.

Optimized 2D-RT for Prostate Cancer

Definition of Fields Margins for Optimized 2D Radiotherapy of Prostate Carcinoma

Twenty patients with prostate cancer (CAP) were identified. Pelvic MRI images were fused with CT-simulation images to delineate prostate and seminal vesicles on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP with or without involvement of the seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV. For each patient, 8 treatment plans were calculated using box tecnhique: 2 treatment plans for each risk category were calculated by using a cobalt source or 10 MV photons. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 \> 95%), distances of the fields edges from a set of reference points were measured.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Professor

Head and Neck Neoplasms

The intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.

The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses

The intervention will be delivered by a radiation oncology nurse. Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.

In-person education sessions

Radiation Oncology Nurse will hand participant the NCI booklet

NCI Booklet

written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.

Survey

A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.

Interview

Susan Mazanec, PhD, RN

Patients with head and neck cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study tests whether different forms of education and support can help family caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.One group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses. The caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life. In addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements. This pilot study will only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Main Campus.

Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.

Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.

Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.

Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer

Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer

Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.

Descriptive statistics will be used to summarize responses to semi-structured interviews

Feasibility will be assessed via attrition and consent rates.

Time for delivering the intervention will be recorded to aid in assessing costs.

Integrity of the intervention will be assessed through monitoring of intervention checklist.

Describe the average incidence of all patient events that may be impacted by caregiver self-efficacy. Events may include acute care visits, admission to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course, and others

Case Comprehensive Cancer Center

Symptoms and General Pathology

Behaviors and Mental Disorders

Hemorrhage

Quality of Life

All Drugs and Chemicals

Androgens

Prostate Immobilization Device

Anthony V. D'Amico, MD, PhD

During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.

* MRI using an endorectal coil done prior to treatment for staging.
* Baseline Quality of Life (QOL) assessment will be completed prior to treatment.
* Total androgen suppression is initiated and will continue for at least 6 months.
* Prostate Immobilization Device (PID) placed during the planning session.
* PID will be placed daily for the first 15 3D external beam radiation treatments.
* QOL assessment and follow-up will take place every 6 months for 3 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Simulating Outcomes From Breast Conserving Surgery Using 3D Surface Imaging	NCT03250260	Breast Cancer F...	3-dimensional p... Viewing of a 2-...	18 Years -	Royal Marsden NHS Foundation Trust
Optimized 2D-RT for Prostate Cancer	NCT03339531	Prostate Cancer	2D radiotherapy	18 Years - 79 Years	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer	NCT02577237	Head and Neck C...	In-person educa... NCI Booklet Survey Interview	18 Years -	Case Comprehensive Cancer Center
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding	NCT00114985	Prostate Cancer	Prostate Immobi...	31 Years - 80 Years	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for simulation

Every month we try and update this database with for simulation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for simulation

Every month we try and update this database with for simulation cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for simulation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.