Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Will complete consult with the use of an artificial intelligence program Chatbot.

Will complete a traditional in-person genetic counseling. consult by meeting with a Genetics Counselor

Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)

Automated program (ChatBot)

Genetics counselor

Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)

BCGCKQ Survey

Survey assessing satisfaction with Decision-Genetic Testing

Satisfaction Survey

Genetic testing for all participants will assess for a mutation in 47 genes commonly associated with hereditary cancer syndromes (Invitae's Common Hereditary Cancer Panel) for those who choose to complete testing.

Genetic testing

Zahraa Al-Hilli, MD

The purpose of this study is to help better understand the uptake and impact of genetic testing for women diagnosed with breast cancer who do not meet National Comprehensive Cancer Network (NCCN) criteria for genetic testing. By doing so, the research team will gain a better understanding of the clinical implications for offering genetic testing for all patients recently diagnosed with breast cancer versus only offering genetic testing to those meeting NCCN criteria.

By offering genetic counseling and genetic testing to all women recently diagnosed with breast cancer, there will be a shortage of genetic counselors. This study will also assess the feasibility of using artificial intelligence to assist in the genetic counseling process.

This is a randomized trial comparing the effectiveness of pre-test genetic counseling using an artificial intelligence program and traditional in-person genetic counseling in women newly diagnosed with breast cancer who do not currently meet National Comprehensive Cancer Network (NCCN) criteria for genetic testing.

The primary objectives of this study are:

1. To determine up-take of testing for those who do not meet NCCN guidelines for genetic testing
2. To assess overall patient satisfaction and comprehension in both groups

The secondary objectives of this study are:

1. To assess mutation rate in the overall cohort
2. Identify reasons for not pursuing genetic testing
3. Identify any specific areas of improvement in satisfaction and comprehension
4. Assess the impact of genetic testing on Time to Treatment in this cohort
5. Develop workflow for offering genetic testing, providing pre-test genetic counseling, ordering testing, and delivering results

Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer

A Randomized Trial Comparing the Effectiveness of Pre-test Genetic Counseling Using an Artificial Intelligence Program and Traditional In-person Genetic Counseling in Women Newly Diagnosed With Breast Cancer Who do Not Currently Meet National Comprehensive Cancer Network (NCCN) Criteria for Genetic Testing.

Commercially available software being used to conduct the study

Up-take of testing for those who do not meet NCCN guidelines for genetic testing

Mean overall patient satisfaction with decision about genetic testing as assessed by survey. The survey is a previously validated six-question Likert scale based survey. The scale ranges from 6 to 30, with higher scores indicating more satisfaction.

Satisfaction will be compared between groups with t-test or Wilcoxon rank sum test. Published data suggest that standard deviation on the satisfaction survey is 3. A 2 point difference in average satisfaction score between groups is considered to be relevant

Comprehension as assessed by previously validated survey consisting of 27 questions, which are a blend of True or False and multiple choice questions. The scale ranges from to , with higher scores indicating more comprehension.

Comprehension will be compared between groups with t-test or Wilcoxon rank sum test.

Mutation rate as described by percentage of overall cohort with mutation. Groups will be compared with Chi-square test or Fisher's exact test

Number of patients who decline genetic testing. Groups will be compared with Chi-square test or Fisher's exact test

Reasons for not pursuing genetic testing in those who declined will be collected as a descriptive measure and then analyzed as frequencies of the different responses, summarizing the most common answers

Time to treatment will be compared between patients who had genetic testing to those who did not using t-test or Wilcoxon rank sum test among all study patients.

Case Comprehensive Cancer Center

Behaviors and Mental Disorders

Quality of Life

Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.

One-off distribution of a flyer to the patient containing both general information on sexual health and contact telephone numbers and e-mail addresses for oncosexology help

Quality of life questionnaire : EORTC QLQ-C30, EORTC QLQ-Breast cancer module (BR) 23, EORTC SHQ-C22 et HADS at inclusion, visit 1 (6 months +/-1 month before the inclusion), visit 2 (12 months +/-1 month before the inclusion), visit 3 (18 months +/-1 month before the inclusion) and visit 4 (24 months +/-1 month before the inclusion).

Quality of life questionnaire (QLQ)

The satisfaction score will be collected using a visual analog scale from 0 to 10 and the satisfaction questionnaire will also be completed at visit 4 (24 months +/- 1 month before the inclusion).

Satisfaction survey

Assessment of patient needs in the field of oncosexology during a face-to-face or virtual interview at inclusion and every 6 months for 2 years. If a need is identified, an oncosexology consultation will be organised. Following this, a personalised care plan may be proposed.

Assessment of patient needs in the field of oncosexology

Aurore MOUSSION

Emmanuelle TEXIER

Aliette DEZELLUS, Dr

Claire CHARRA-BRUNAUD, Dr

Philippe TOUSSAINT, Dr

Véronique D'HONDT, Dr

Angélique BOBRIE, Dr

Anne CREISSON, Dr

Frédéric FITENI, Dr

Silène DELORME

Eva JOUVE, Dr

Marion AUPOMEROL, Dr

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients.

Breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. Given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. Sexual health is a crucial component of well-being and overall quality of life.

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request.

For that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years.

Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

EORTC Sexual Health Questionnaire (SHQ)-C22 specific questionnaire sexual satisfaction scale score.

Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level.

Scores obtained on the EORTC SHQ-C22 questionnaire scales. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level.

Scores obtained on the scales of the EORTC QLQ-C30. Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Scores obtained on the scales of the QLQ-BR23 This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.

The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms.

Coefficients obtained with a model adapted for longitudinal quality of life data scores as a function of covariates potentially associated with sexual and global quality of life.

Anxiety and depression (psychological distress variables) will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire.

The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.

Percentage of adherence in the interventional arm

Satisfaction score measured on a visual analogue scale ranging from 1 to 10 (10 indicating high satisfaction)

Institut du Cancer de Montpellier - Val d'Aurelle

Head and Neck Neoplasms

Videos and written instructions on Hatha yoga will be provided

Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided

A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.

Yoga Video

The strengthening video directs patients through a sequence of isometric exercises to strengthen neck, shoulder and core muscles that are critical for good posture and musculoskeletal integrity. The patient may opt to do the strengthening exercises standing, sitting or with their back on the floor depending on their strength. The video lasts 20 minutes.

Posture and Strengthening Video

The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes

Relaxation Video

The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.

Breath Work Video

Participants will complete a questionnaire addressing satisfaction with the yoga program.

Instructor guided yoga session twice a week

Guided Yoga Session

Written Yoga Instructions

Barbara Murphy, MD

This is a randomized prospective pilot study assessing the safety and feasibility of two yoga interventions in head and neck cancer patients undergoing primary or adjuvant radiation with or without concurrent chemotherapy

Primary Objective:

- To assess the safety and feasibility of Hatha yoga in head and neck cancer patients undergoing treatment with primary or adjuvant radiation with or without chemotherapy.

Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation

Feasibility Study of a Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation

Number of adverse events as graded by CTCAE 4.0

At least 50% of patients will need to moderately compliant to be feasible (Compliance will be defined as:Fully Compliant: Participation in at least 1 yoga activity on at least 70% of days on study; Moderately Compliant: Participation in at least 1 yoga activity on at least 40% of days on study;Noncompliant: Participation on less than 40% of days on study)

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Sponsor Investigator

Patient Navigator (PN) Intervention Group. In addition to the Baseline Questionnaire and the Follow-up Questionnaire, PN intervention participants will complete a brief Patient Navigator Satisfaction Survey.

Usual Care (UC) Control Group. Control sample of patients not receiving PN intervention will complete a Baseline Questionnaire and the six-week Follow-up Questionnaire. Participants under UC will have access to all services typically provided to Moffitt Cancer Center (MCC) patients. Any baseline distress score greater than three will be reported to the patient's primary oncologist and clinic nurse.

Patient navigation (PN) is an intervention model designed to assist vulnerable patients in overcoming health system, personal and/or logistical barriers to care throughout the cancer care continuum. The strategic aims of PN are to reduce barriers and improve disease outcomes while also reducing distress and enhancing quality of life for the patient and family. Participants in the PN group will meet with a patient navigator.

Patient Navigator (PN)

Complete a baseline questionnaire online or by meeting with a member of the study team. This questionnaire has items asking about the participant's health, distress levels, satisfaction with their care at Moffitt Cancer Center, and what support services they have used since their diagnosis. This questionnaire will take about 15 to 20 minutes of their time.

Baseline Questionnaire

After participants complete the baseline questionnaire, they will be asked to complete a follow-up questionnaire approximately 6 weeks from when they completed the baseline questionnaire. The follow-up questionnaire will take about 15 to 20 minutes to complete.

Follow-up Questionnaire

Evaluation of Patient Navigator intervention process.

Patient Navigator Satisfaction Survey

Kristine Donovan, PhD, MBA

The purpose of this study is to develop and test a model of patient navigation that investigators hope will address the unique needs of adolescent and young adult (AYA) cancer patients and their families by minimizing barriers in their care and potentially improving the outcomes of their treatment while reducing distress and enhancing quality of life. Investigators plan to achieve this by increasing access to, and use of, the resources available at Moffitt Cancer Center for AYA patients and their families.

Up to 80 participants may be recruited to this study at Moffitt Cancer Center to obtain a final sample size of 60 completed participants.

Participants will be identified in consultation with the patient's primary oncologist and program social worker. A research assistant (RA) will verify eligibility and consent eligible patients.

After completing a baseline questionnaire, participants will be randomly placed into one of two groups. Both groups will receive their normal care, but one group will also meet with a patient navigator. Participants in both groups will be asked to complete a follow-up questionnaire approximately 8 to 10 weeks from when they complete the baseline questionnaire. The follow-up questionnaire will take about 15 to 20 minutes to complete.

Participation in the study will last about 10 weeks.

Patient Navigation in the Adolescent and Young Adult (AYA) Cancer Population

Rate of participants reporting satisfaction with the patient navigator service, based on survey response scores.

Follow-up Questionnaire scores for Patient Navigator group vs. Control group, as compared to Baseline Questionnaire Scores. Distress Indicator: Rating of 0 to 10, with 0 being No Distress and 10 being Extreme Distress). Health and Well Being Rating Categories: General health; Activity limitations; Problems with regular activities; Frequency of physical or emotional problems. Satisfaction with Care: Rating of 1 to 5, with 1 being Strongly Disagree and 5 being Strongly Disagree for 29 questions. Service Use: Regarding information and informational resources provided at Moffitt Cancer Center.

H. Lee Moffitt Cancer Center and Research Institute

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

EORTC QLQ-C30, EORTC QLQ-GI.NET21 and satisfaction survey

Quality of life questionnaire that has to be completed every 6 months

EORTC QLQ-C30

EORTC QLQ-GI.NET21

Questionnaire regarding satisfaction of care that has to be completed on Day 1.

Timon U Vandamme

Isolde Van der Massen

Wim Demey

Laura Wuyts

Timon Vandamme

Marijke Ulenaers

Willem Lybaert

Frank Van Fraeyenhove

Isabelle Maurissen

Neuroendocrine tumors (NET) are rare tumors that require specific diagnosis and treatment. Therefore, this poses a challenge for clinical practice. Diagnosis and treatment can be optimized when physician specialists and other healthcare providers, across various hospitals, join forces to provide patients the best care. Based on this idea, a hospital network called NETwerk was set up. The following hospitals are part of this network: University Hospital Antwerp, VITAZ, AZ Monica, AZ Voorkempen, AZ Klina, Gasthuiszusters Antwerpen, Ziekenhuis Netwerk Antwerpen and AZ Rivierenland. In this NETwerk, patients with a neuroendocrine tumor or patients suspected with a neuroendocrine tumor are discussed with the specialists and treated.The aim of this study is to map the quality of life of NET patients within NETwerk in order to optimize the quality of care. Throughout the diagnosis, the treatment process and the follow-up, the patient will be asked to fill out three questionnaires (QLQ-C30, QLQ-GI.NET21 and a satisfaction survey). These questionnaires will be filled out every six months at home. Patients will be asked to complete these questionnaires over a period of five years.

Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk

Quality of life measurement with QLQ-C30 questionnaire

Quality of life measurement with QLQ-GI.NET21 questionnaire

Quality of care measurement with satisfaction survey

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer	NCT04354675	Breast Cancer	Automated progr... Genetics counse... BCGCKQ Survey Satisfaction Su... Genetic testing	18 Years -	Case Comprehensive Cancer Center
Effectiveness of AI Genetic Counseling Program vs In-person Genetic Counseling in Breast Cancer	NCT04354675	Breast Cancer	Automated progr... Genetics counse... BCGCKQ Survey Satisfaction Su... Genetic testing	18 Years -	Case Comprehensive Cancer Center
Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request	NCT06415266	Breast Cancer	Quality of life... Satisfaction su... Assessment of p...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request	NCT06415266	Breast Cancer	Quality of life... Satisfaction su... Assessment of p...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation	NCT04146779	Head and Neck C...	Yoga Video Posture and Str... Relaxation Vide... Breath Work Vid... Satisfaction Su... Guided Yoga Ses... Written Yoga In...	21 Years -	Vanderbilt-Ingram Cancer Center
Patient Navigation in the Adolescent and Young Adult (AYA) Cancer Population	NCT03176576	Cancer	Patient Navigat... Baseline Questi... Follow-up Quest... Patient Navigat...	18 Years - 39 Years	H. Lee Moffitt Cancer Center and Research Institute
Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk	NCT05268783	Quality of Life	EORTC QLQ-C30 EORTC QLQ-GI.NE... Satisfaction su...	18 Years -	University Hospital, Antwerp

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