Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genetic Predisposition to Disease

Disease Susceptibility

Endometrial Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Uterine Neoplasms

Uterine Diseases

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Participants are provided with a link to the Michigan Department of Health and Human Services (MDHHS) informational website and are instructed to follow up with their oncology provider about genetic testing.

Participants receive access to an online genetics tool, the virtual genetics navigator, to help learn why and how to seek out genetic testing for hereditary cancer syndromes.

Participants receive up to 2 phone calls from trained genetics health coaches who provide information about genetic testing and use motivational interviewing to encourage participants to seek out clinical genetic testing.

Participants may view the publicly available Michigan Department of Health and Human Services (MDHHS) website as they wish.

Publicly available genetic testing resources

A mobile-optimized website/online genetic tool developed by investigators from the University of Michigan's Center for Health Communications Research (CHCR).

Virtual genetics navigator

At least 2 phone calls delivered by trained genetic health coaches using motivational interviewing and providing genetic testing information.

Motivational interviewing (MI)

Cancer AnswerLine

Elena Stoffel, MD, MPH

The primary purpose of this study is to compare three interventions, two experimental and one standard of care (usual care), to see if the experimental interventions will increase the likelihood of a participant obtaining guideline-concordant genetic testing. Eligible participants will be randomized (assigned) to one of the following interventions: 1) Virtual genetics navigator, a mobile-optimized website, designed by the investigators, that delivers tailored messages and content; 2) two motivational interviewing (MI) telephone calls delivered by trained genetics health coaches; or 3) usual care.

This trial will be conducted in partnership with the Michigan Department of Health and Human Services (MDHHS) and a network of oncology practices in Michigan, the Michigan Oncology Quality Consortium (MOQC).

As of April 2023 we were approved by our IRB to expand our inclusion criteria and recruitment cohort. This expansion will enhance our reach to individuals who are not in the acute stages of clinical care as well as individuals who are not in oncology care currently yet still qualify for genetic testing based on their family history of cancer alone or in combination with any personal cancer history. These expansions will also support the unburdening of oncology practices - who continue to face downstream, resource-limiting affects from the COVID-19 pandemic - across the state. The goal and aims of the study remain the same.

Methods for Increasing Genetic Testing Uptake in Michigan

The primary outcome is completion of genetic testing (yes/no) at 6 months after randomization by patient self-report.

Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 7-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.

Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 23-item, study-specific survey, developed by the investigators to assess the importance of specific barriers that were identified in a previous, observational study. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the barriers in importance. A higher mean score indicates greater importance of that specific barrier.

Participants who have completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all; 5=extremely). The mean score for each question, across all participants who completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.

Participants who have not yet completed genetic testing (before the 6- or 12-month time point for this survey) will be asked to respond to this 5-item, study-specific survey, developed by the investigators to assess the importance of specific motivators for future testing. Each item is scored on a scale from 1-5 (1=not at all, 5=strongly agree). The mean score for each question, across all participants who have not yet completed genetic testing, will be calculated in order to rank the motivators in importance. A higher mean score indicates greater importance of that specific motivator.

National Cancer Institute (NCI)

University of Michigan Rogel Cancer Center

We will use a prospective, observational cohort design, we will invite a sample of individuals who have indicated willingness to be re-contacted for future studies (from existing protocols involving cancer survivors and their unaffected relatives employing mixed methods -qualitative interviews coupled with validated measures - to assess: the proportion of participants experiencing psychological distress from Whole genome/exome sequencing (WGS/WES) results.

We will also recruit an additional group of participants from the general public (with or without a cancer history) who have not had their genomes or exomes sequenced to participate in focus groups to inform us about their perceptions of the hypothetical utility of learning of incidental results from their genome or exomes. For our sampling purposes, this group of participants is referred to as the 'focus group participants (sample #3-hypothetical group)

A week before the participants return to the clinic to learn of their results, the RSA will call each participant to complete the Hospital Anxiety \& Depression Scale (HADS), revised Impact of Events Scale (IES-R), \& a questionnaire about their health behaviors, to establish baseline distress levels \& health behaviors. A week later, participants will return to the Clinical Genetics Service to review their results with the genetics provider \& discuss resultant therapeutic \& management recommendations for the participants \& their relatives. A week later, the RSA will call each participant to complete the HADS, IES-R again, to establish the safety of receiving these results. Participants will also be asked to complete the revised Multidimensional Impact of Cancer Risk Assessment (MICRA) measure. The RSA will also invite participants to complete an in-depth telephone interview.

qualitative interviews

Mark Robson, MD

This study uses new methods called "genome sequencing" that allow the investigators to study part or all of a person's genome. The genome is the collection of all of a person's genes. Genes carry the instructions that our bodies need to develop and function. Genes are passed on from one generation to the next. Genome sequencing can study all of a person's genome (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the study, the investigators refer to all these research methods as 'genome sequencing'. Genome sequencing typically shows a large number of gene changes, known as "variants." Some (but not all) of these genetic variants may be linked to increased risks of diseases other than cancer.

The purpose of this study is to learn what kinds of genetic variants the patient wants to learn about from their genome.

Participants will be recruited from cohorts of patients whose DNA samples are being examined with WGS/WES as part of efforts to identify novel cancer susceptibility alleles. Participants will be derived from the following protocols: 09-068 and 96-051.

A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results

of receiving incidentally identified disease risk results from whole genome/exome sequencing. Safety is defined as no more than 20% of participants experiencing clinically meaningful levels of distress at 1 week follow-up, as measured by the Hospital Anxiety \& Depression Scale (HADS; score \> or = to 8 on the anxiety sub-scale). Patients will be considered evaluable for the primary outcome if they are not distressed at baseline and have completed the 1 week follow-up assessment.

Memorial Sloan Kettering Cancer Center

Behaviors and Mental Disorders

Depression

Depressive Disorder

Behavioral Symptoms

Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention

Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention

Sessions for both arms (BP \& SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:

* Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks).
* Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).

Behavioral Activation

Supportive Psychotherapy

Rebecca Saracino, PhD

Christian Nelson, PhD

The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)

A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 consists of nine items, each of which corresponds to one of the nine symptoms required for a diagnosis of a major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders. Respondents are asked to rate how often they have been bothered by each of the nine symptoms over the preceding two weeks. Respondents rate each item on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). Its reliability and validity have been established in diverse general and medical populations. Total scores range from 0-27; In outpatient cancer settings, psychometric research suggests that a score of ≥8 indicates clinically significant depressive symptoms and should be used as a clinical cut-off .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Methods for Increasing Genetic Testing Uptake in Michigan	NCT05162846	Breast Cancer Colorectal Canc... Ovarian Cancer Prostate Cancer Pancreatic Canc... Endometrial Can... History of Canc...	Publicly availa... Virtual genetic... Motivational in...	18 Years -	University of Michigan Rogel Cancer Center
A Safety Study Assessing the Effects of Receiving Genome Sequencing Results	NCT01692223	History of Canc...	qualitative int...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors	NCT05574127	Survivorship	Behavioral Acti... Supportive Psyc...	65 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for history of cancer