Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Prostatic Neoplasms

Sarcoma

Carcinoma, Renal Cell

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Kidney Neoplasms

Colorectal Neoplasms

Carcinoma

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms, Connective and Soft Tissue

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Adenocarcinoma

Pancreatic Cancer

Ovarian Cancer

Renal Cell Carcinoma

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review.

It is expected that about 20 people will take part in this part of the research study.

In the larger part of the study that will happen after this part of the study, it is expected 1000 people will participate.

A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling

Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit

Video Education

Genetic Counseling

Huma Q. Rana, MD. MPH

Huma Q Rana, MD

Huma Q. Rana, MD., MPH

The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.

This study consists of two parts:

* Qualitative assessment:

  * This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants.
  * The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial.
* Randomized control trial:

  * A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants

Video Education With Result Dependent dIsclosure

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Pre- and post-test of knowledge of hereditary cancer risk and cancer genetic counseling with qualitative patient interview question domains and instruments to assess understanding of language and imagery of video education as correlated with measures of health literacy.

National Cancer Institute (NCI)

National Human Genome Research Institute (NHGRI)

Dana-Farber Cancer Institute

Principal Investigator

Behaviors and Mental Disorders

Symptoms and General Pathology

Anxiety Disorders

Facies

This video contains the same instructions that the patient receives when they arrive at the clinic, as well as a video walk through of the clinic/patient room. Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions.

This arm will receive the standard-of-care verbal/written instructions and the pre-operative video explanation. These instructions contain the same content as in the pre-operative videos

Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions. The videos will be split into two modules: 1) preparing for Mohs Surgery 2) Mohs Surgery Walk through. The intervention, in the form of a video walk through, will be provided to the patient via email prior to their surgical procedure once they schedule an appointment with the Mohs clinic for their surgery day.

Pre-Operative Videos

As part of the standard of care for patients receiving Mohs surgery, patients are told about the day of their surgery and what to expect

verbal instructions

As part of the standard of care for patients receiving Mohs surgery, patients receive written material about the day of their surgery and what to expect

written instructions

Jeremy S. Bordeaux, MD, MPH

The purpose of this research is to look at how educational videos might affect patient satisfaction and anxiety before Mohs surgery day. Patients will be randomized to either: 1) a group that receives educational videos before the visit in addition to standard-of-care written and verbal instructions OR 2) a group that receives only standard-of-care written and verbal instructions.

The primary objective of this study is to determine if pre-operative videos describing the patient's forthcoming day in the Mohs clinic decrease pre-operative patient anxiety and increase postoperative patient satisfaction, when added to standard of care written and verbal instruction.

Design/Study Type This study will be a randomized control trial in which patients will be randomized to either the intervention (pre-operative Mohs Surgery video viewing) or control (standard of care) group in order to understand the impact of the video on patient anxiety and satisfaction. Patients will be randomized using an Accelerated Biased Coin Design in the statistical program R.

Impact of Videos on Patient Anxiety and Satisfaction

Impact of Pre-Operative Videos on Mohs Surgery Patient Anxiety and Satisfaction

For subject satisfaction score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a six item instrument with individual scores ranging from 1-5 (total score 6-30). Higher scores indicate greater satisfaction.

For subject anxiety score, the mean Likert scale rating for the control and intervention groups will be compared. The scale being used is a seven item instrument with individual scores ranging from 1-5 with positive worded items scored in reverse (total score 7-35). Higher scores indicate greater anxiety

Case Comprehensive Cancer Center

* Participant is given a pamphlet introducing genetic testing
* Participant is given information utilized for clinical, standard of care testing.
* Will receive genetic information with a virtual interactive Chatbot prior to genetic testing. After the Chatbot education, participant is asked if they would like to proceed with genetic testing.
* Participant is asked to complete an electronic family history tool

* Participant is given a pamphlet introducing genetic testing
* Participant is given information utilized for clinical, standard of care testing.
* Participant will watch a brief educational video that is approximately 8 minutes in length about the genetic testing process and what to expect prior to genetic testing. After the video education, participant is asked if they would like to proceed with genetic testing.
* Participant is asked to complete an electronic family history tool

Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit

Chatbot

Brief video designed to mirror the educational components of a traditional genetic counseling visit

This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.

In this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: Chatbot and video education.

The first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message.

The Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling.

The second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer.

In both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing.

Other studies at both DFCI and outside institutions have started to investigate alternative methods of educating patients about genetic testing. These studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care.

The investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. The investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result.

OPTimizing Treatment Focused Genetic Testing IN Cancer

OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

The proportion of participants who consent to genetic testing in each study arm

Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.

A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly".

For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature.

Three items will assess participants' intentions to disclose genetic testing results

This will evaluate participant's discussions about genetic testing within the family for an understanding of how genetic testing information was communicated

5 items will be asked pertaining to reflecting on the decision of the participant about getting genetic testing after learning about their result.

A 6 item survey evaluating participant's understanding of inherited genetic risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Video Education With Result Dependent dIsclosure	NCT05225428	Genetic Testing Breast Cancer Ovarian Cancer Pancreatic Canc... Prostate Cancer Colorectal Canc... Renal Cancer Melanoma Sarcoma	Video Education Genetic Counsel...	18 Years -	Dana-Farber Cancer Institute
Impact of Videos on Patient Anxiety and Satisfaction	NCT03485937	Mohs Surgery	Pre-Operative V... verbal instruct... written instruc...	18 Years -	Case Comprehensive Cancer Center
OPTimizing Treatment Focused Genetic Testing IN Cancer	NCT04066361	Breast Cancer Ovarian Cancer Pancreatic Canc... Prostate Cancer	Chatbot Video Education	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for video education