| Background:Colorectal cancer(CRC)has become one of the most common malignant tumours in the world.The number of new cases and deaths of CRC was 555,000 and286,000,respectively in the year of 2020 China,and the trend is increasing.Genetic factors are potentially linked to approximately 20%to 30%of CRCs.Genetic susceptibility to CRC includes well-defined inherited syndromes that constitute 5%to10%of all CRCs,such as Lynch syndrome and familial adenomatous polyposis.Individual who was diagnosed inherited CRC syndrome substantially increases the risk of contracting colorectal and endometrial cancer;it also increases the risk of ovarian,stomach,small bowel,urinary tract,and brain cancer.Identification of hereditary CRC syndromes offers an opportunity for optimizing therapy and managing future risk for patients,and for early detection and prevention of cancer for asymptomatic carriers of hereditary CRC syndromes-associated mutations.High-risk individuals may be identified based on phenotypic criteria,including family history and patient-specific factors,such as age at diagnosis and tumor phenotype.Further genetic testing to diagnose the hereditary CRC syndromes is recommended based on family history of cancer and patient-specific factors.However,decision making regarding genetic testing is complicated.Individuals need to cope with many limitations of genetic testing,such as the purpose and implications of the uncertain test results,and the impact of the testing on their family.At present,there are few studies on promoting informed decision-making of CRC genetic evaluation.And the genetic counseling system needs to be improved in China,which cannot meet the needs of patients and their relatives.Therefore,it is imperative to develop a support tool that is suitable for the clinical situations in China and can promote informed decision-making for patients and relatives and uptake of CRC genetic evaluation for at-risk individuals.Objective:The Delphi method was used to develop a family-centered decision aids tool for CRC genetic evaluation based on the Ottawa Decision Support Framework.To assess the feasibility and effectiveness of decision aids intervention for informed decision-making by patients or their relatives.Methods:This study takes the Ottawa Decision Support Framework as the theoretical framework,and was carried out in a total of five steps:(1)Effectiveness of interventions to inform decision making of CRC genetic evaluation:A systematic review.Ten electronic databases were searched to identify eligible clinical trials from each database's inception to March 25,2020.The reference lists of the included studies and reviews were checked for additional articles.Studies were screened and independently appraised by two reviewers using the standardized critical appraisal checklist for randomized controlled trials and quasi-experimental studies from the Joanna Briggs Institute.The results were tabulated and reported in descriptive format.(2)Factors of decision conflicts and information needs of patients and their relatives in genetic testing for hereditary CRC.A cross-sectional study design and convenience sampling method were used to select 312 CRC patients and their relatives from a tertiary and class-A hospital in Changchun,China.Data including demographic characteristics,hereditary CRC and genetic testing knowledge,attitude,decision conflicts and decisional needs were collected.Independent samples t-test/rank sum test/?~2 test and logistic regression were used to analyze the factors of decision conflicts and decisional needs.(3)A qualitative study on the decision-making process of patients and their relatives in CRC genetic evaluation.Using the descriptive,qualitative method and purposive sampling was used to select participants(25 patients or relatives,and 12medical practitioners and nurses)in a tertiary and class-A hospital in Changchun,China.We conducted individual semi-structured interviews to them.The data were analyzed using qualitive content analysis.(4)To develop a decision aids tool for CRC genetic evaluation based on the Ottawa Decision Support Framework.According to the Ottawa Decision Support Framework,and based on relevant literature and guidelines,considering the current status of tumor genetic screening practice in China and the decisional needs of patients or relatives,developed a family-centered decision aids tool for CRC genetic evaluation.The decision aids tool was further improved after Delphi method.(5)Feasibility and effectiveness of a decision aids intervention to inform decision making of CRC genetic evaluation.Convenience sampling was used to select CRC patients and relatives from a tertiary and class-A hospital in Changchun,China.They were randomly assigned to the intervention group or the control group.The participants in intervention group were given the decision aids and animation video intervention.The control group maintained usual nursing practice.Participants'knowledge,decision conflicts,decision self-efficacy,quality of life,and healthy lifestyle were assessed at baseline,immediately after the intervention,and at 6 weeks after the intervention.Generalized estimating equations(GEE)was used to evaluate the difference in outcome changes between the intervention group and the control group during the intervention period,so as to test the effect of decision aids to inform decision making of CRC genetic evaluation on patients and their relatives.Results:(1)Effectiveness of interventions to inform decision making of CRC genetic evaluation:A systematic review.A total of 4 studies satisfied the inclusion criteria and were included.The studies examined intervention strategies related to education(n=3)and decision aids(n=1).Educational and decision aids interventions had positive effects on the uptake of CRC genetic evaluation for at-risk individuals and their informed decision-making.Decision aids may be important during decision making process and may improve patients'understanding of genetic testing.Compared with educational intervention,the characteristics of decision aids were balanced information about different decision options,patient stories,and a value clarification exercise.(2)Factors of decision conflicts and information needs of patients and their relatives in genetic testing for hereditary CRC.The mean of the knowledge questionnaire was 7.65±3.81,and 65.2%of the participants had a positive attitude towards the genetic testing of hereditary CRC.The median of decision conflicts was58.59(39.06,71.88),and only 7.4%of the participants had no decision conflicts;77.9%of participants hoped to obtain more knowledge and information about hereditary CRC and genetic testing.Logistic regression analysis showed that age(OR=4.376,95%CI:1.402–13.665,P=0.011),knowledge(OR=0.046,95%CI:0.005–0.420,P=0.006),stage of decision-making(OR=0.159,95%CI:0.039–0.653,P=0.011;OR=0.210,95%CI:0.054–0.813,P=0.024)and choice predisposition/decision(OR=8.145,95%CI:1.874–35.399,P=0.005)were independent influencing factors for decision conflicts.Age(OR=0.242,95%CI:0.123–0.475,P<0.001)and choice predisposition/decision(OR=0.090,95%CI:0.030–0.269,P<0.001;OR=0.319,95%CI:0.136–0.751,P=0.009)were independent influencing factors of support needs.(3)A qualitative study on the decision-making process of patients and their relatives in CRC genetic evaluation.Six main categories for patients and relatives were eventually generated,including the cognition of and attitude towards hereditary CRC and genetic testing,the informed decision-making of hereditary CRC genetic testing and factors of decision-making,decisional support and support needs for hereditary CRC genetic testing.Five main categories for doctors and nurses were eventually generated,including genetic literacy,attitude towards and clinical practice of hereditary CRC genetic testing,barriers to implementation of clinical genetic screening,and how to response to the obstacles of genetic screening.Patients,relatives,doctors and nurses all have insufficient awareness of hereditary CRC screening and diagnosis.Due to insufficient knowledge of patients and medical staff and lack of genetic screening resources in medical institutions,medical practitioners rarely provide genetic evaluation advice and adequate information support to high-risk patients and their relatives.As a result,most patients and their relatives face decision conflicts and have decisional needs in genetic screening and testing.(4)To develop a decision aids tool for CRC genetic evaluation based on the Ottawa Decision Support Framework.According to the Ottawa Decision Support Framework,and based on relevant literature and guidelines,considering the current status of tumor genetic screening practice in China,and the decisional needs of patients and their relatives,developed a family-centered decision aids tool for CRC genetic evaluation.(5)Feasibility and effectiveness of a decision aids intervention to inform decision making of CRC genetic evaluation.Finally,82 relatives of CRC patients were included in this study.Decision aids tool had significant effect on knowledge,decision conflicts,decision self-efficacy and healthy lifestyle scores(P<0.05).Most of the participants in intervention group were satisfied with this study,believed that the content of intervention was well understood,the amount of information was comprehensive and sufficient,and they were satisfied with the way of providing information based on We Chat.Conclusion:(1)Due to the lack of knowledge of patients,relatives,and medical staff,and insufficient clinical genetic screening resources,patients and their relatives have not received sufficient decision support for genetic testing of hereditary CRC,and they have huge decisional needs.It is necessary to develop and implement decision-support intervention for patients and their relatives.(2)The decision aids tool for genetic testing of hereditary CRC is feasible and effective to a certain extent in domestic clinical situations.(3)This study adds evidence to the related field,provides a basis for improving the construction and implementation of relevant intervention programs,and for nurses to participate in the work of tumor genetic screening. |
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