Sites randomized to Strategy I will receive a three hour training webinar in preparing for implementation of the PAT in their center.

Sites randomized to Strategy II will identify a Champion for screening and will participate in a monthly consultation call in addition to completing the three hour training webinar for implementing the PAT in their center.

The training webinar is a three hour training. The purpose of the study is to implement the Psychosocial Assessment Tool (PAT) in their center.

Training Webinar

In addition the Training Webinar, sites randomized to Strategy II will identify a Champion and will participate in monthly consultation calls in support of implementation of the PAT

Training Webinar Plus Implementation Enhanced Resources (TIER)

The diagnosis and treatment of pediatric cancer adversely affects multiple levels of the social ecology, including patient and caregiver physical and psychosocial health. It is the strong recommendation from the first Standard of the Psychosocial Standards of Care in Pediatric Cancer that cancer centers engage in universal, systematic, psychosocial risk screening for newly diagnosed patients and their families. Universal screening at diagnosis fosters early identification of psychosocial risks and provides the opportunity to match psychosocial care to the level of family need for more equitable, effective and integrated services. However, few programs offer such care in an efficient, comprehensive, and consistent manner, potentially resulting in insufficient care that magnifies inequities in outcomes. To support pediatric cancer centers in their goal of meeting the first Standard of Psychosocial Care, this study will compare two implementation strategies for the Psychosocial Assessment Tool (PAT), a validated parent report screener of family psychosocial risk in English and Spanish, in a cluster randomized trial across 18 pediatric cancer programs in the United States.

Background: Childhood cancer affects multiple levels of the social ecology, including social determinants of health (e.g. financial and resource issues, child and family problems). The 2015 Standards of Psychosocial Care in Pediatric Cancer outline optimal psychosocial care, starting with a standard devoted to assessment of psychosocial healthcare needs. The Psychosocial Assessment Tool (PAT) is a validated family psychosocial risk screener now ready for broad implementation. Method: The PAT will be implemented across a national sample of 18 pediatric cancer programs in a comparative effectiveness study, guided by the Interactive Systems Framework for Dissemination and Implementation, comparing two Strategies. It is hypothesized that implementation will be more successful at the patient/family, provider, and institutional level when Training (Strategy I) is combined with Implementation Expanded Resources (Strategy II). The trial will be informed by input from Stakeholders and will result in a web-based Toolkit for dissemination nationally. Sites will be randomized to cohort (one of three years) and strategy (Strategy I, II) for the trial. Outcomes include adoption and penetration of screening (patient/family), staff job satisfaction/burnout (provider), and cost effective use of resources consistent with family risk (institution). Discussion Use of the PAT across children's cancer programs nationally can achieve the assessment Standard and deliver psychosocial care matched to family need for all patients, especially those most impacted by health inequities.

Based on the Interactive Systems Framework for Dissemination and Implementation (ISF), this study is a comparative effectiveness trial of the two strategies at 18 childhood cancer centers of three sizes based on new patients per year, examining family (penetration, health equity), provider (feasibility, acceptability, burnout and job satisfaction), and institution (adoption, sustainability, costs) implementation outcomes.7 Sites will be randomized to time of implementation (three cohorts) and Strategy (two - I, II).

Aim. Compare the two theoretically based and empirically informed strategies to implement the PAT in English and Spanish using a cluster randomized controlled trial. Compared to Training:

H1. At the patient/family level, TIER will be associated with: a) a higher proportion of families of newly diagnosed children screened and provided with feedback (penetration); and b) higher rates of screening for ethnic minority and socioeconomically diverse families (health equity).

H2. At the provider level, TIER will be: a) more feasible and rated as appropriate and acceptable; b) associated with greater engagement in addressing health disparities; and c) associated with less burnout and better job satisfaction.

H3. At the institution level, TIER will be associated with: a) a higher rate of site participation (adoption), b) more positive perceptions of implementation benefits and fewer challenges (sustainability); and c) psychosocial care better matched to need demonstrating a more equitable distribution of services and costs of care.

All sites, regardless of randomization to Strategy I or II, will participate in a 3-hour professionally prepared internet based learning session (webinar) at the beginning of their cohort. Each site PI, all staff who will be directly involved in screening, and the research coordinator will participate. For sites randomized to Strategy II, the Champion will also attend. The investigators will work with sites to identify the team that will participate in screening and the Champion (in TIER) ("individuals who dedicate themselves to supporting, marketing, and driving through an implementation, overcoming indifference or resistance that the intervention may encounter in an organization"), recognizing that these determinations will vary across programs. The webinar will be professionally prepared to be engaging and effective as an educational approach with resource materials provided (Develop Educational Materials, Distribute Educational Materials).

The training webinar will include all information necessary to access the web-based PAT. Sites will be provided with a User Agreement, user manual, and access to the password protected site. The completed PAT is scored immediately and a summary of the score and clinical concerns identified is sent. Only de-identified data will be transmitted to the study data core. Sites will be supported in the technical aspects of the implementation related to using the web-based forms (Centralize Technical Assistance). If any pattern of problems with technical aspects of implementation is identified, the study staff will communicate with sites promptly. During training, each site PI and staff involved in screening will develop a specific implementation plan, describing who will implement the PAT, who will be screened, where results will be stored, how results will be communicated and how results will be used (Develop a Formal Implementation Blueprint). For TIER, the Plan includes questions about the Champion and the Consultation Calls.

Strategy I. For sites randomized to Strategy I (Training), the webinar is the implementation condition. Sites will also receive technology support, as needed, throughout the one-year implementation period. These strategies correspond to implementation strategies: creating a structure for implementation including creating implementation teams, developing an implementation plan.2

Strategy II. Strategy II, Training + Implementation Expanded Resources (TIER), includes the same webinar and technical support as in Strategy I with the addition of two evidence-based resources that may improve implementation (as finalized from analysis of Aim 1 interviews). The Site PI and center staff conducting screening will participate in a monthly one-hour PAT Implementation Consultation Call (Provide Ongoing Consultation, Create a Learning Collaborative). The group format of this strategy is intended to foster group problem-solving about common issues in implementation and provide peer support for those implementing the PAT. The data regarding implementation progress and challenges from the calls will be addressed in subsequent calls and will be considered in the development of the Toolkit. Second, sites will identify a Champion for PAT implementation (Identify and Prepare Champions), most likely be a division chief, nurse in a leadership role, or clinical administrator.

At the Patient/Family level the following data for the English and Spanish versions of the PAT will be reported monthly: new patients meeting eligibility requirements as outlined on the PAT Implementation Plan (n); patients with documentation of PAT screening (n); patients with evidence of family feedback letter (n); demographic data (race, ethnicity, zip code, insurance). As part of the PAT Implementation Plan, the Site PI and Coordinator will determine institution-specific ways to identify new patients and their demographic characteristics.

At the Provider level the Site PI and staff identified as screeners will complete self-report measures at baseline and at 6 and 12 months.

There are four outcomes at the Institution level. The first outcome is adoption, or the intention of sites to use the PAT, by examining the site participation rate. To evaluate the extent to which screening is perceived as an asset to the institution electronic health record data (EHR) data will be extracted and aggregated at the site level for each family at 30, 60 and 90 days after screening. It provides a sum of hospital based services and external referrals and the number and length of inpatient and outpatient visits, missed appointments and evidence of non-adherence or difficulties in delivering care, allowing determination of healthcare utilization or medical services delivered. Cost will be assessed to understand the relationship among PAT risk level, psychosocial services provided, and aspects of medical care that may reflect unnecessary or inefficient services. Because the care provided may be related to the intensity of medical treatment, the Intensity of Treatment Scale will be used.

Analysis

H1. ANOVA will compare the effectiveness of the two implementation strategies on penetration and health equity. The outcomes are proportions: families screened/families eligible, families provided feedback/families screened, ethnic minority families screened/ethnic minority families eligible, low socioeconomic status (SES) families screened/low SES families eligible. Interclass Correlation Coefficients (ICC) among the clusters will be calculated and used to adjust for the cluster effect.

H2. Three sets of outcome variables - perception of implementation, engagement in addressing health disparities, and burnout/job satisfaction - will be tested. A two group analysis with the framework of Structural Equation Modeling (SEM) will be conducted to compare the effectiveness of the two strategies. To test the effect of time (T1, T2, T3), latent growth curve analysis will be conducted; it is expected that provider outcomes will improve over time. Analyses will be performed using Mplus 5.0 with ML estimation for outcome variables that meet the distribution assumptions, and with Robust Least Weighted Squares (WLSMV) estimation for outcome variables that do not. Potential mediating effects of favorable perception of implementation on provider job satisfaction and burnout will be examined using mediation models. TIER is expected to be associated with more favorable perceptions of implementation, which in turn will lead to less burnout and higher job satisfaction.

H3. At the institution level adoption of the PAT will be measured by a ratio of sites that initiate implementation/sites that agreed (H3a). If substitutions are necessary, sites that are newly invited will be added to the denominator and adoption calculated by total acceptances/total invited. ANOVA will be conducted to compare the effectiveness of the two strategies. For H3b sustainability (PIQ perceptions of implementation benefits and challenges), ANOVA will be conducted to compare the effectiveness of the two strategies on benefits and challenges. For H3c the interest is in the extent to which psychosocial care is matched to need and the extent to which intensive medical and psychosocial services are delivered for those most in need. There has not yet been established a cost-effectiveness threshold or criterion to which to compare costs of screening with these two implementation strategies, necessitating our consideration of valued outcomes in the psychosocial screening literature and resources available. ANOVA will be conducted to test whether psychosocial care is matched with levels of psychosocial risks, resulting in a 2 (Strategy) x 3 (psychosocial risks: clinical, targeted, universal) design on distribution of services and costs of care. It is expected that the 3 levels of the Pediatric Psychosocial Preventative Health Model (PPPHM) will be related to number and costs of services provided as measured on the Psychosocial Services and Medical Treatment Checklist (PSMTC). Additional analyses will be conducted to compare English speaking and Spanish speaking families, different ethnicity, race, and SES and insurance status on the outcome variables.

This is an implementation trial in which institutions are assigned to conditions. There is no masking.

Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer

Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer With The Psychosocial Assessment Tool (PAT)

The investigators will share de-identified data upon reasonable request.

Number of families screened divided by number of families eligible

Number of sites that completed the study divided by sites enrolled

Number of families provided feedback divided by number of families screened

Number of ethnic minority families screened divided by number of ethnic minority families eligible

Changes in level of engagement in addressing health disparities as measured by the AREA, a 9 point scale with a 5 point likert response. Total scores range from 0 to 36 with higher scores indicating higher level of engagement

Changes in burnout measured with this 22 item scale with a items on a 7 point Likert scale, higher scores indicate higher job satisfaction. Range of scores is from 0 to 42.

Changes in acceptability of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher acceptability

Changes in perceived appropriateness of the PAT using this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher appropriateness

Changes in perceptions of the feasibility of using the PAT measured with this four item survey on a 5 point likert scale; range of scores is from 5 to 25; higher score is higher feasibility

Children's Hospital of Philadelphia

American Cancer Society, Inc.

Nemours Children's Clinic

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Syndrome

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Quality of Life

Mailed questionnaire that contains questions about experiences living with colorectal cancer, take 45-60 minutes to complete. The phone interview should take 30-45 minutes to complete.

The phone interview should take 30-45 minutes to complete.

Telephone Interview

Mailed questionnaire that contains questions about experiences living with colorectal cancer, take 45-60 minutes to complete.

Questionnaire

Susan Peterson, MPH,PHD

Objectives:

Specific Aims:

1. Researchers will evaluate and compare predictors of health-related quality of life (QOL) among colorectal cancer (CRC) survivors who have Lynch syndrome (LS) with those patients who have sporadic CRC using both quantitative and qualitative methodology.

   a. In both CRC groups, researchers will evaluate cancer preventive and health behaviors, including lifestyle factors and screening, psychosocial factors, including mood, family functioning, coping style, anxiety, depression, and social resources, and health care system factors, including interactions with health care providers and service utilization.
2. Researchers will compare the experience of first-degree relatives (FDRs) of patients who have LS with that of FDRs of patients who have sporadic CRC using both quantitative and qualitative methodology.

   a. Researchers will evaluate all of the domains listed above, as well as anticipatory grief, assessment of caregiving responsibilities, and fear of cancer in FDRs of patients with LS-related and sporadic CRC.
3. Researchers will examine CRC patients from both groups and their FDRs using dyadic analyses in order to evaluate the similarities and differences in their survivorship experience.
4. Researchers will evaluate the preventive and health behavior of patients who are non-conclusive for Lynch syndrome and their family members. They will examine their screening behavior and will explore how the interaction between the patients and their relatives affects the relatives' screening behavior. They also will examine how these non conclusive LS patients and their family members perceive their risk for LS-related cancers.

Data will be collected primarily using a mailed self-administered questionnaire. A subset of the participants who complete the mailed questionnaire will be recontacted and invited to participate in an in-depth, semi-structured telephone interview.

Qualitative Mailed Questionnaires:

Participants will complete a questionnaire that contains questions about your experiences living with colorectal cancer. The questionnaire should take 45-60 minutes to complete.

Up to 200 colorectal cancer survivors and up to 200 close relatives of colorectal cancer survivors will take part in this portion of the study.

Telephone Interviews:

In the phone interview, you will be asked some questions about your experiences living with colorectal cancer. The phone interview should take 30-45 minutes to complete.

Up to 30 colorectal cancer survivors and up to 30 close relatives of colorectal cancer survivors will take part in this portion of the study.

Survivorship in Lynch Syndrome Families

Cancer Survivorship in Lynch Syndrome: Impact on Patients and Families

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Individuals with mesothelioma who have a BAP1 or other DNA repair/cancer predisposition mutation regardless of CLIA confirmation

Individuals with a CLIA confirmed BAP1 or other DNA repair/cancer predisposition mutation who do not have a diagnosis of mesothelioma

Maria Garcia L Agra, R.N.

Raffit Hassan, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

-A gene provides instructions to the body. Mutated genes can sometimes cause cancer. Germline mutations are those people are born with. These mutations in the BAP1 gene can cause mesothelioma and other cancers. Researchers want to study people with germline mutations of BAP1 and other genes known to cause cancer.

Objective:

-To learn how cancer might develop in people with certain gene mutations.

Eligibility:

-People ages 2 and older with a germline mutation in BAP1 or another gene that might cause cancer

Design:

* Participants will be screened with:

  * Medical and family history
  * Saliva test
* Participants with mesothelioma will be in the NIH Group. Participants without mesothelioma can choose to be in either the NIH Group or the Remote Group.
* Remote Group participants will have a medical and family history by phone. If they have tumor tissue from a previous surgery, it will be tested. They will be contacted once a year by phone.
* NIH Group participants will have a baseline visit. This can take up to 4 days. They may have to stay in the area overnight. The visit will include:

  * Physical exam
  * Evaluation of tumor tissue if available
  * Optional tumor biopsy
  * Blood tests
  * Scans: A machine will take pictures of the body.
  * Photographs of skin lesions or other issues
  * Skin exam
  * Eye exam
* NIH Group participants will have visits once or twice a year. These will include a physical exam, lab tests, scans, and other tests as needed.
* Participants who have a confirmed mutation will be asked to contact any relatives who may be at risk and ask them about joining the study.

Background:

* BRCA1-Associated Protein-1 (BAP1), a deubiquitinase involved in regulating DNA repair enzymes, is believed to be a prominent mutation in malignant mesothelioma
* Germline mutations involving BAP1 have been reported in familial studies. These have been associated with a higher likelihood of mesothelioma as well as several other malignancies, including uveal melanoma, cutaneous melanomas, renal cell carcinoma and cholangiocarcinoma
* BAP1 mutations, if found, have a high probability of detecting multiple malignancies in family members.

Objectives:

-To characterize the natural and clinical history of malignant mesothelioma patients and their family members who have germline mutations in BAP1 and other DNA repair/cancer predisposition genes

Eligibility for Genetic Testing:

Cohort 1

-Individual with mesothelioma with deleterious germline mutations in BAP1 or another DNA-repair/cancer predisposition gene(s) (previous testing may have been research or clinical)

OR

* Individual with a diagnosis of mesothelioma who is otherwise eligible for testing on Cohort 2
* Age greater than or equal to 2

Cohort 2

-Individual with a germline BAP1 mutation who does not have a history of mesothelioma (previous testing may have been research or clinical)

OR

-Individual with no personal history of mesothelioma with:

--a first degree biological relative (living or deceased) with a history of mesothelioma

OR

--a first degree biological relative with a CLIA confirmed germline mutation in BAP1

OR

--a second degree biological relative with a CLIA confirmed germline mutation in BAP1 if relevant first degree relative is deceased or unavailable for testing

OR

--a first degree biological relative with mesothelioma and a CLIA confirmed germline mutation in another DNA-repair/cancer predisposition genes

OR

--a second degree biological relative with mesothelioma and a CLIA confirmed germline mutation in BAP1

-Age greater than or equal to 16 unless participant has a BAP1 mutation or a first degree biological relative with a confirmed TP53 or BAP1 germline mutation; in such cases, will begin screening at age greater than or equal to 2

Eligibility for Surveillance:

Cohort 1

-No additional criteria

Cohort 2

-Testing performed on study must confirm presence of germline mutation in BAP1 or another DNA repair/cancer predisposition gene(s)

Design:

* Individuals with suspected hereditary predisposition to mesothelioma and their families will be recruited to assess for genetic mutations, and to study the natural history of malignancies occurring in germline BAP1 mutations as well as other mutations involved in DNA repair.
* Screening examinations will be offered to those with germline BAP1 mutations as well as other mutations involved in DNA repair/cancer predisposition.
* We will determine if there is a relationship between germline mutation and disease phenotype.

Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Standard exploratory and descriptive measures will be used. Counts, incidence, and frequencies of cancers identified via screening procedures on this trial will be reported, all in the context of an exploratory study with appropriate caveats.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer	NCT04446728	Pediatric Cance...	Training Webina... Training Webina...	-	Nemours Children's Clinic
Survivorship in Lynch Syndrome Families	NCT01126840	Colorectal Canc...	Telephone Inter... Questionnaire	18 Years -	M.D. Anderson Cancer Center
Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes	NCT03830229	Mesothelioma Families		2 Years -	National Institutes of Health Clinical Center (CC)
Survivorship in Lynch Syndrome Families	NCT01126840	Colorectal Canc...	Telephone Inter... Questionnaire	18 Years -	M.D. Anderson Cancer Center
Survivorship in Lynch Syndrome Families	NCT01126840	Colorectal Canc...	Telephone Inter... Questionnaire	18 Years -	M.D. Anderson Cancer Center
Implementation of Family Psychosocial Risk Assessment in Pediatric Cancer	NCT04446728	Pediatric Cance...	Training Webina... Training Webina...	-	Nemours Children's Clinic
Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes	NCT03830229	Mesothelioma Families		2 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for families

Every month we try and update this database with for families 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 families

Every month we try and update this database with for families 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 families 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.