Genetic Counseling and Testing: Cancer Genetics
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1 KAISER PERMANENTE HAWAII CLINICAL PRACTICE GUIDELINE Genetic Counseling and Testing: Cancer Genetics QUALITY COMMITTEE ADOPTION DATE: October 2015 LAST REVIEW DATE: September 2015 NEXT SCHEDULED REVIEW DATE: September 2017 PROVIDER/STAFF DISTRIBUTION DATE: October 2015 GUIDELINE METHODOLOGY: Evidence Based MD ENDORSEMENT: Julie Won Ireland, MD, FACMG CONTACT PERSON(S): Rebecca Yee Bassett, MS,CGC DEPARTMENT(S): Genetics TELEPHONE: This protocol is adapted from Trepanier et al (2004), Genetic Cancer Risk Assessment and Counseling Recommendations of the National Society of Genetic Counselors, and the article by Riley et al (2012), Essential Elements of Genetic Cancer Risk Assessment, Counseling, and Testing: Updated Recommendations of the National Society of Genetic Counselors. I. Referrals All referrals must be submitted by a clinician at Kaiser Permanente Hawaii Region Patients will be referred due to a personal and/or family history suggestive of increased familial or hereditary risk for cancer, and not limited to those who are potential candidates for genetic testing Appointments will be scheduled for a genetic consultation with a board certified or board eligible genetic counselor who is supervised by a medical geneticist If requested or indicated, patients will be referred for a clinical genetic evaluation with a medical geneticist When indicated patients will also be referred to other clinicians for further treatment, risk reduction, and high risk screening II. Intake 1. Medical History a. All patients Age Biopsy history of benign and malignant tumors Major illness, medical conditions, hospitalizations Surgeries Reproductive history Cancer screening/surveillance Non-genetic risk factors (i.e., smoking, EtOH, environmental exposures) b. Patients with a history of cancer Site of origin Age at diagnosis/year Multiple primary tumors and/or metastatic sites Genetic Counseling and Testing: Cancer Genetics Page 1
2 Stage, pathology, and tumors markers Prior, current, or planned treatment regimen (i.e., surgery, chemotherapy, radiation) 2. Family History a. Documentation of a 3-4 generation pedigree Maternal and paternal family history obtained Each family member will have the current age or age and cause of death Each family member will have relevant health/cancer history documented Standardized nomenclature should be used Ethnicity/ancestry documented Pedigree should be updated periodically to maintain accuracy b. Targeted questions for hereditary risk assessment Cancer screening habits Prior surgical intervention (i.e., risk reducing surgeries) Carcinogen exposure Non-random associations with other cancers and other clinical features associated with certain cancer genetic syndromes should be noted Confirmation of familial mutations, cancer diagnoses, etc. should be obtained when applicable c. Limited family structure should be noted Adoption Small family size Individuals who died at young ages Number of male v. female relatives when assessing risks for gender specific cancer susceptibility III. Hereditary Risk Assessment 1. Overall hereditary risk impression - average, moderate, or high risk for cancer susceptibility Multiple relatives with same or similar cancer Early age at diagnosis Multiple primary tumors or bilateral diagnosis in paired organs Rare cancers or tumors Unusual or excessive benign lesions (i.e., polyps, nevi, papillomatosis) Ethnicity 2. Establish a differential diagnosis a. When appropriate a referral for physical examination by a medical geneticist or other specialist will be recommended b. Follow up patients will be given up-to-date risk assessment with the advent of new tests and technologies 3. Provide probability modeling when applicable a. Hereditary breast and ovarian cancer BRCAPRO BOADICEA Tyrer-Cuzick Gail/Claus Myriad Prevalence Tables Genetic Counseling and Testing: Cancer Genetics Page 2
3 b. Hereditary Non-Polyposis Colorectal Cancer/Lynch syndrome MMRPRO PREMM1,2,6 Myriad Prevalence Tables 4. Cancer risk assessment will be performed in all risk groups Including low risks for identifying mutations, in the absence of genetic testing, and when no mutation is found by currently available testing Current screening guidelines (i.e., NCCN, ACS) and chemoprevention (i.e., Tamoxifen use) should be mentioned Clinical judgment should always prevail, even if contradictory with probability modeling IV. Genetic Testing for Hereditary Cancer 1. Genetic testing should be offered under the following circumstances: The personal or family history is suggestive of an inherited cancer syndrome The genetic test can be adequately interpreted Testing will influence medical management of the patient or relatives The potential benefits outweigh the risks The patient is not coerced and voluntarily agrees to testing The patient or their legal representative is able to provide informed consent 2. Cancer genetic testing should generally not be offered to individuals less than 18 years of age, unless: The child has already been diagnosed with cancer There is an increased risk for childhood onset cancers Screening and risk reducing interventions are available in this age group 3. Parents must be appropriately counseled regarding the potential impact of the testing There is little data regarding long-term impact on children who test positive Reproductive impact and testing options will also be thoroughly discussed Including but not limited to gamete donation, egg/embryo preservation, in vitro fertilization (IVF), pre-implantation genetic diagnosis (PGD), and prenatal diagnosis Discussion of management issues for potential offspring as an adult V. Informed Consent 1. Informed consent a necessary component of genetic testing and should precede genetic testing by a trained health care provider 2. Elements of Informed Consent for Genetic Testing a. Purpose of testing and who should be tested Why is the test being offered How the results might impact the patient and/or family members Importance of testing affected individuals first Limitations of initially testing unaffected individuals b. General information about the gene(s) Which gene(s) are being tested Cancer risks associated with each gene Genetic Counseling and Testing: Cancer Genetics Page 3
4 Mode of inheritance Concepts of genetic heterogeneity, incomplete penetrance, and variable expressivity c. Possible test results Positive Result i. Pathogenic mutation is found and specific guidelines available regarding individuals with this genetic condition ii. Provides an opportunity for at risk relatives to undergo counseling and testing Negative Results i. Uninformative Negative Absence of known pathogenic mutation in the family Must be interpreted with caution with regard to patient and the family for screening and risk reduction failure to counsel appropriately may lead to non-adherence ii. True Negative Patient does not carry known familial mutation No increased risk for cancer based on affected family members with known mutation other family history risk factors should still be considered Variant of Uncertain Significance (VUS) i. Pathogenicity of genetic variant is unknown ii. Testing unaffected relatives not recommended clinically, but research studies may help with establishing clinical significance iii. Utilization of mutation evaluation programs online might help with interpretation, but do have limitations which should be noted d. Technical aspects and accuracy of the test Likelihood of false-positive and false-negative Turnaround time Method of disclosure e. Economic considerations Cost of testing Insurance coverage/reimbursement and pre-verification f. Possibility for genetic discrimination Federal and state legislation to reduce genetic discrimination i. GINA limited to health insurance and employment for unaffected individuals ii. HIPAA protection for affected individuals with regard to health insurance iii. ADA protection for affected individuals with regard to employment g. Psychosocial aspects Anticipated reaction to results and coping strategies Timing and readiness of testing Family dynamics and issues Preparing for result disclosure h. Confidentiality HIPAA requires health care providers to protect all medical information, including genetics Genetic Counseling and Testing: Cancer Genetics Page 4
5 Patients should have the right to know who will be receiving results, including post-mortem access to records i. Utilization of test results Risk reducing options Surveillance Individualized approach based on cancer risk assessment, genotype, family history, personal medical history, diet, and social habits j. Alternatives to genetic testing Genetic testing should be free from coercion and patients should understand their care will continue regardless of whether they elect genetic testing Reasons patients may decline genetic testing include: i. Lack of interest ii. Indecision iii. Inadequate insurance coverage iv. Uninformative result in an affected family member If a patient declines genetic testing, risk assessment and screening recommendations will be made on the basis of the personal risk factors and family history information When appropriate and feasible, DNA banking should be discussed to allow access to at-risk family members in the future VI. Disclosure of Genetic Test Results 1. In all cases (positive, negative, uncertain) the following should be discussed with each patient Personalized interpretation of result Cancer risk assessment Identification of at-risk family members 2. In-person disclosure is recommended based on complexity of interpretation and emotional responses, although telephone disclosure is appropriate in certain circumstances Elements of Disclosure Address questions and concerns prior to disclosing result Disclose result with interpretation Assess patient understands and reaction to result provide emotional support Review medical and psychological impact of result on patient and family Explain sensitivity, specificity, and limitations of test performed Re-assess cancer risk and management guidelines/recommendations Refer to other appropriate health care providers Identify at risk family members, and provide patients with tools to inform and educate family members (family contact letters, websites, referral to genetics) If a patient refuses to inform family members, evaluation of ethical/legal duty to warn should be assessed. Consultation with HIPAA compliance officer and ethics committee should be performed by provider. 3. Cancer screening and prevention options for individual and family members Position in pedigree Genetic test results for individual and family members Related medical history 4. Patients with positive test results Genetic Counseling and Testing: Cancer Genetics Page 5
6 Conditions with published consensus guidelines/management NCCN, ACS, ACOG, SGO, AGA, ATA Conditions without consensus management guidelines Detailed literature review and options for research participation Notification of at-risk relatives Follow up counseling recommended 5. Patients with negative test results Residual risk assessment based on personal history, family history, and modeling Discussion of testing other affected family members due to presence of phenocopies Discussion of differential diagnosis and possible additional genetic testing Discussion of limitations with regard to knowledge and technology Periodic follow up recommended to reassess genetic risk and testing options VII. Psychosocial Risk Assessment 1. Critical in pre- and post-test counseling Identify motivation for consultation Inquire about understanding of genetic counseling and testing process Identification of misconceptions should be addressed in a sensitive manner Psychosocial issues should be assessed Worry, anxiety, intrusive thoughts, depression, anger, fear, guilt Family experiences with cancer Perception of risk for self and others Competence for giving informed consent Social stressors and support networks Family communication Readiness for testing 2. Identify patients who will require additional professional assistance and counseling Refer to Behavioral Health Department DISCLAIMER Adherence to this clinical recommendation is voluntary. The recommendations provided should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedures must be made by the physician in light of the individual circumstances presented by the patient. Copyright 2012 All rights reserved. Genetic Counseling and Testing: Cancer Genetics Page 6
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