Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294379
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-12-19
Brief Title:
Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy Development of a Decision Aid Tool
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to develop test and evaluate a Patient Decision Aid called The Decision Helper among melanoma patients eligible for adjuvant treatment
Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice
Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper pre-implementation compared to the ones who have post-implementation
Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice
Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper pre-implementation compared to the ones who have post-implementation
Detailed Description:
Malignant Melanoma Worldwide the incidence of melanoma of the skin continues to increase Cutaneous melanoma is the most lethal skin cancer worldwide In alignment with the global trend the number of Danes who are diagnosed with malignant melanoma has also increased significantly during the last 50 years In Denmark approximately 400 persons are diagnosed with metastatic disease each year Although more people are diagnosed with melanoma there has only been a minor increase in the number of people who die from the disease This is primarily due to improved treatment modalities The development of immunotherapy and targeted therapy have been the most important breakthroughs in melanoma treatment In the last decade immune checkpoint inhibitors CPIs have improved survival significantly for patients with metastatic melanoma However the immune-related adverse events irAEs that patients may experience can be severe and potentially life-threatening
Adjuvant therapy When it comes to the treatment of malignant melanoma it is not only in the metastatic setting that treatment options have improved disease control The scene has also changed when it comes to adjuvant treatment where CPIs also play an increasingly important role Until recently the standard of care after completely resected stage III melanoma was active surveillance In stage III melanoma the cancer has spread from the skin cells to the lymph nodes which means that these patients are considered to have a high risk of recurrence a part of them will at some point experience a relapse with metastatic disease Consequently several drugs to prevent recurrence after surgery have been tested in melanoma over the years but until recently none had proven effective The first drug to change this was the CPI Ipilimumab In 951 patients with resected melanoma at high risk of recurrence stage IIIa IIIb or IIIc disease the effectiveness of Ipilimumab as adjuvant therapy was tested The recurrence-free survival was significantly improved in favor of the patients who had received Ipilimumab compared with placebo 5-year rate of recurrence-free survival was 41 in the ipilimumab group as compared with 30 in the placebo group However more than half of the patients experienced severe irAEs Ipilimumab was never approved as a standard adjuvant treatment in Denmark due to the high risk of severe irAEs However in December 2018 two other CPIs Nivolumab and Pembrolizumab were approved as adjuvant treatment for stage IIIa IIIb or IIIc resected disease Nivolumab has proved to increase recurrence-free survival when compared to ipilimumab 4-year recurrence-free survival was 52 in the Nivolumab group and 41 in the ipilimumab group In addition only around 14 of the patients who receive monotherapy with Nivolumab experience a grade 3 or 4 adverse events AE Similar results were found in another study investigating the CPI anti-PD1 antibody Pembrolizumab The overall risk of recurrence was reduced by approximately 40 across stages as a result of adjuvant therapy with Pembrolizumab after 3 years 12 Despite the gain in recurrence-free survival there I not always a bestright decision regarding adjuvant treatment In the following the pros and cons for starting adjuvant treatment will be described in more detail illustrating the inherent dilemma between clinical benefit and irAEs
The challenges of adjuvant therapy - to treat or not to treat There is prognostic heterogeneity within the group of stage III melanoma patients The risk of experiencing a relapse varies depending on whether a patient is diagnosed with stage IIIA disease or stage IIIC disease AJCC 7th Edition Thus some patients have a low risk of recurrence stage IIIA while others are at greater risk stage IIIC following complete resection
Patients with stage IIIC also have more to gain from a prognostic perspective than patients with stage IIIA disease if they receive adjuvant treatment Even though all patients with stage III disease are eligible for adjuvant therapy the decision to initiate treatment is not unproblematic Furthermore the number of melanoma patients who are candidates for adjuvant treatment is likely to increase in the future Randomized controlled trials are currently investigating if patients with stage IIBC melanoma can also benefit from adjuvant therapy The argument is that these patients have a prognosis similar to patients with stage IIIB melanoma
In addition to the fact that some patients are considered to be at low risk of relapse there is also the question of toxicity Almost 80 of the patients who receive adjuvant immunotherapy experience some kind of irAE and approximately 14 of the patients experience severe irAEs that in some cases can be fatal
Moreover severe toxicities can impact patients quality of life OReilly et al conclude in a paper published in 2019 that melanoma patients who had received immunotherapy have potentially experienced significant irAEs during treatment resulting in chronic conditions and exposure to significant doses of steroids Accordingly they had significantly lower health-related quality of life scores about physical social and physical role functioning and general health compared with healthy controls Moreover ifwhen patients relapse with metastatic disease they are often offered treatment with the same drug as they would have received in the adjuvant setting which may support the argument that some of the patients are better off waiting On the other hand patients of course prefer not to have a relapse Thus there is not always an obvious best treatment and the decision to treat or not to treat can be challenging It is currently not well understood how patients eligible for adjuvant immunotherapy make their decision to accept or not accept treatment and careful consideration and discussion about the potential risks and benefits must be carried out with each patient In addition to disease recurrence physicians must keep several factors in mind such as patient age comorbidity and personal preferences
Patient involvement As it is impossible to predict which patients will benefit from the treatment international guidelines developed for other patient populations suggest that adjuvant systemic treatment particularly in cases where there is little to gain for example patients with stage IIIA disease should be discussed with the patient This recommendation to include the patients when it comes to decisions about treatment and care is in line with the general trend within the health care system The Danish National Survey of Patient Experiences LUP stresses that the dimension patient involvement is the most poorly rated area of all dimensions rated by the patients in the survey Moreover the Region of Southern Denmark decided in 2019 that Shared Decision Making SDM should be deployed in all hospitals in the region Thus both politicians as well as patient organizations have an increased focus on involving the patients more engagement
Shared Decision Making - a possible game changer According to the Danish Melanoma Group approximately 100 patients are eligible for adjuvant treatment annually at the Department of Oncology Odense University Hospital Patients and physicians face the difficulties described above when having to decide which melanoma patients are to receive adjuvant therapy Sometimes the choice may seem obvious because the patients may have a relatively high risk of recurrence In other situations where the patients have a low risk of recurrence or comorbidities which may make treatment with immunotherapy risky it is more complex In such cases SDM could be useful to support this preference-sensitive decision SDM is defined as an approach where clinicians and patients share the best available evidence when faced with the task of making decisions and where patients are supported to consider options to achieve informed preferences and in making treatment decisions that align with these preferences A Danish lung cancer study from 2019 showed that patients who had been engaged in SDM had lower decisional conflict and regret Furthermore they felt more confident about the decision and the process facilitated that patients values played a more central role in decision-making One way to increase the level of patient-perceived involvement and make the consultations in the outpatient clinic more uniform may be to use a patient decision aid PtDA to support shared decision-making If the patients experience that they are part of the decision process it may also result in a lower level of decisional regret as described above
Patient Decision Aids In other countries such as the United States decision-support tools have been developed containing information on what the patients need to know about stage III melanoma The patients can find information about the disease substages adjuvant therapy vs active surveillance side effects and outcomes With this information in mind the patients may be able to weigh the options with their treating oncologist to come to the right decision Only a few decision aids have been developed and tested scientifically in a Danish context As mentioned adjuvant therapy as standard treatment is a relatively new treatment option for patients with melanoma and no recipe guidesdescribes how to reach the right shared decision for the individual patient However a study carried out in oncology care and pulmonary medicine demonstrates how the use of a patient decision aid PtDA enhanced SDM in two different settings and helped increase focus on patient preferences 25 This study used a generic patient decision aid template called Decision Helper developed by the Center for Shared Decision Making in the Region of Southern Denmark CFFB Therefore the center now offers a platform for decision-aid templates that adhere to the certification and quality criteria set by the International Patient Decision Aid Standards IPDAS Utilizing log-in healthcare providers have access to the platform and the template for building patient decision aids BESLUTNINGSHJÆLPER and will be able to build and develop PtDAs tailored to their specific needs The template is developed based on the IPDAS criteria
Study 1 - Development of the Patient Decision Aid
Methods As both patients and clinicians are the end-users of the PtDA both groups will participate in an iterative process to ensure that patient needs are prioritized and that the PtDA is relevant accurate and easy to use Thus instead of just seeing the patients as a source of data they will play an active role in the design phase of the PtDA A qualitative approach will be applied using semi-structured interviews as recommended in IPDAS guidelines where melanoma patients and clinicians will identify the type and amount of information needed for creating relevant and appropriate PtDA As a supplement to this another qualitative method observational will be used as a researcher the project manager will observe the patient-clinician communication before the introduction of the PtDA in a natural situation to collect data on the communication between the patient and clinician how the talk is organized and the level of patient involvement
Phase 1 Preparation of the Patient Decision Aid
Observation by researcher in the outpatient clinic - 5 consultations
An expert group consisting of physicians and nurses will look at PROs and CONs for receiving treatmentnot receiving treatment
Interviews with melanoma patients who have already decided whether to receive treatment or not about their views and preferences and what they see as advantages and disadvantages An interview guide will be prepared to ensure uniformity and all aspects are covered Three patients who have accepted treatment and three patients who have declined will be included
Phase 2 Design of the Patient Decision Aid
The PtDA will be prepared following the views and preferences of patients and clinicians with the following content
Introduction It must be clear to the patients that a PtDA is used in the consultation for the patient and the clinician to make a decision together
The choices must be clear to the patient observation or treatment
Focus on patient preferences - what matters to the patient
Description of the different choices using 4 cards describing
PROs and CONsrisks and benefits
Patient stories patients who have made the choice already see phase 1
Statistics risk of relapse
Timeline Description of the trajectory for both choices treatment or observation
Data entered into IT platform 1 Draft prepared Informationdata from phase 2 is entered into the IT platform BESLUTNINGSHJÆLPER and the first draft is ready The Center of Shared Decision-Making will provide support and feedback
User test - 2 draft prepared A user test is carried out including individual interviews with 3-4 patients and 3-4 clinicians For the patients a semi-structured interview guide will be used that is based on the items from the Preparation for Decision-Making Scale Similarly a guide will be prepared for clinicians Based on the findings from the interviews and usability testing the decision helper will be refined and changes will be entered into the IT platform
Trial period - 3 draft prepared The final version is printed and a trial period of approximately 12 weeks will take place If no further adjustments are required the PtDA is ready for implementation
Study 2 - Evaluation of the PtDA Hypothesis The implementation of the PtDA will result in an increased level of patient involvement among melanoma patients eligible for adjuvant immunotherapy In addition the patients will experience less decisional regret Moreover the consultations in the outpatient clinic will become more uniform and consistent
Aims To investigate 1the level of patient involvement and 2decisional regret among melanoma patients receiving adjuvant therapy before and after implementation of the PtDA In addition 3 to examine if the consultations become more uniform and consistent
Methods Since the aim was to examine the level of patient involvement decisional regret and the uniformity and consistency of consultations before and after the implementation of the PtDA it has been decided to use a pre-post study design Although this design does not take other factors that may change during the study into account it may be able to suggest if the outcome is impacted by the intervention A mixed method approach will be used to evaluate the effect of the PtDA using both quantitative data and the Decision Regret Scale and qualitative data individual interviews and focus group interviews A convergent design is selected in which survey data and interview data are collected in parallel over the same period This will be described in more detail for each of the three aims in the following
- Level of patient involvement Qualitative data The level of patient involvement will be examined using a qualitative approach by conducting interviews with eligible patients before and after implementation Due to the exploratory nature of the study the sample size cannot be determined in advance but the aim is to include 10-15 patients for both pre and post-interviews depending on when data saturation has been reached A purposive sample of patients will be selected to ensure maximal variation in gender age and treatment choice A semi-structured interview guide will be designed to make the interaction as smooth as possible and the interviews will carried out by the same interviewer to ensure uniformity Members of the project group will participate in the coding and analysis of the interviews Braun and Clarke six step theory will be used for analysis
Quantitative data
Qualitative data Focus group interviews will be carried out with clinicians who take part in outpatient consultations before and after implementation to elucidate if the consultations have become more uniform and consistent after the inclusion of the PtDA Due to the limited number of physicians and nurses caring fortreating the patient population it will only be possible to carry out two focus group interviews before and after The interviews will consist of approximately 5-6 clinicians each As with the individual interviews an interview guide will be prepared and the interviews conducted in a semi-structured manner The same content analysis approach will be applied to the group interview as described above
Quantitative data The plan is to measure the time spent on the individual consultation to elucidate if the time consumption differs between the two groups ie if the length of the consultations has been more uniform after implementation
- Decision regret Quantitative data Patients who have not been exposed to SDM pre-implementation and patients who have been exposed post-implementation will be asked to complete the Decision Regret Scale DRS The DRS is a questionnaire that measures distress and remorse after a healthcare decision The scale consists of 5 questions The scores are converted into a 0-100 scale following the user manual A score of 0 means no regret a score of 100 means high regret
Statistics
Primary outcome DRS 0-100 scale 20 steps mean beforeafter compared by linear regression with bootstrapped standard errors To take into account non-normality of scores Secondary analysis Tested with Wilcoxon rank-sum test Secondary outcomes DRS above cutoffs for mild 5-25 respectively moderatestrong regrets 30 Compared by logistic regression
Supplementary analysis In supplementary analyses above regressions will be adjusted for patient characteristics which might have changed between the before and after periods
Sample size calculations
Collaborators The study is supported by the head of department at the Department of Oncology at Odense University Hospital Two patient representatives and the team physicians and nurses that is responsible for the treatment will play a vital part in developing the PtDA to ensure that all aspects are covered Furthermore the study will be carried out in collaboration with The Center for Shared Decision-Making Finally a cross-sectional survey including various questionnaires was sent out to 427 melanoma patients across Denmark in March this year The Decision Regret Scale DRS is one of the questionnaires in the survey and accordingly it will be elucidated if the patients who have received adjuvant treatment in 2019 and 2020 have had any decisional regret The results will be helpful as historical background data for our project
Perspectives The studies will be based at the Department of Oncology OUH but the project is highly relevant for all melanoma patients in Denmark It is expected to change how outpatient consultations take place enabling the patients to participate in important decision-making regarding their treatment and care It is currently not well understood how patients eligible for adjuvant immunotherapy make their decision to accept or not accept treatment It is expected that the PtDA for melanoma patients receiving immunotherapy in the adjuvant setting can be used nationwide and serve as an example for other researchersclinicians who wish to design a similar tool for other patient populations receiving immunotherapy Moreover because the researchers also aim to evaluate the tool by comparing the level of patient involvement before and after implementation of the Decision Helper it will be elucidated if the designed tool makes a difference
Adjuvant therapy When it comes to the treatment of malignant melanoma it is not only in the metastatic setting that treatment options have improved disease control The scene has also changed when it comes to adjuvant treatment where CPIs also play an increasingly important role Until recently the standard of care after completely resected stage III melanoma was active surveillance In stage III melanoma the cancer has spread from the skin cells to the lymph nodes which means that these patients are considered to have a high risk of recurrence a part of them will at some point experience a relapse with metastatic disease Consequently several drugs to prevent recurrence after surgery have been tested in melanoma over the years but until recently none had proven effective The first drug to change this was the CPI Ipilimumab In 951 patients with resected melanoma at high risk of recurrence stage IIIa IIIb or IIIc disease the effectiveness of Ipilimumab as adjuvant therapy was tested The recurrence-free survival was significantly improved in favor of the patients who had received Ipilimumab compared with placebo 5-year rate of recurrence-free survival was 41 in the ipilimumab group as compared with 30 in the placebo group However more than half of the patients experienced severe irAEs Ipilimumab was never approved as a standard adjuvant treatment in Denmark due to the high risk of severe irAEs However in December 2018 two other CPIs Nivolumab and Pembrolizumab were approved as adjuvant treatment for stage IIIa IIIb or IIIc resected disease Nivolumab has proved to increase recurrence-free survival when compared to ipilimumab 4-year recurrence-free survival was 52 in the Nivolumab group and 41 in the ipilimumab group In addition only around 14 of the patients who receive monotherapy with Nivolumab experience a grade 3 or 4 adverse events AE Similar results were found in another study investigating the CPI anti-PD1 antibody Pembrolizumab The overall risk of recurrence was reduced by approximately 40 across stages as a result of adjuvant therapy with Pembrolizumab after 3 years 12 Despite the gain in recurrence-free survival there I not always a bestright decision regarding adjuvant treatment In the following the pros and cons for starting adjuvant treatment will be described in more detail illustrating the inherent dilemma between clinical benefit and irAEs
The challenges of adjuvant therapy - to treat or not to treat There is prognostic heterogeneity within the group of stage III melanoma patients The risk of experiencing a relapse varies depending on whether a patient is diagnosed with stage IIIA disease or stage IIIC disease AJCC 7th Edition Thus some patients have a low risk of recurrence stage IIIA while others are at greater risk stage IIIC following complete resection
Patients with stage IIIC also have more to gain from a prognostic perspective than patients with stage IIIA disease if they receive adjuvant treatment Even though all patients with stage III disease are eligible for adjuvant therapy the decision to initiate treatment is not unproblematic Furthermore the number of melanoma patients who are candidates for adjuvant treatment is likely to increase in the future Randomized controlled trials are currently investigating if patients with stage IIBC melanoma can also benefit from adjuvant therapy The argument is that these patients have a prognosis similar to patients with stage IIIB melanoma
In addition to the fact that some patients are considered to be at low risk of relapse there is also the question of toxicity Almost 80 of the patients who receive adjuvant immunotherapy experience some kind of irAE and approximately 14 of the patients experience severe irAEs that in some cases can be fatal
Moreover severe toxicities can impact patients quality of life OReilly et al conclude in a paper published in 2019 that melanoma patients who had received immunotherapy have potentially experienced significant irAEs during treatment resulting in chronic conditions and exposure to significant doses of steroids Accordingly they had significantly lower health-related quality of life scores about physical social and physical role functioning and general health compared with healthy controls Moreover ifwhen patients relapse with metastatic disease they are often offered treatment with the same drug as they would have received in the adjuvant setting which may support the argument that some of the patients are better off waiting On the other hand patients of course prefer not to have a relapse Thus there is not always an obvious best treatment and the decision to treat or not to treat can be challenging It is currently not well understood how patients eligible for adjuvant immunotherapy make their decision to accept or not accept treatment and careful consideration and discussion about the potential risks and benefits must be carried out with each patient In addition to disease recurrence physicians must keep several factors in mind such as patient age comorbidity and personal preferences
Patient involvement As it is impossible to predict which patients will benefit from the treatment international guidelines developed for other patient populations suggest that adjuvant systemic treatment particularly in cases where there is little to gain for example patients with stage IIIA disease should be discussed with the patient This recommendation to include the patients when it comes to decisions about treatment and care is in line with the general trend within the health care system The Danish National Survey of Patient Experiences LUP stresses that the dimension patient involvement is the most poorly rated area of all dimensions rated by the patients in the survey Moreover the Region of Southern Denmark decided in 2019 that Shared Decision Making SDM should be deployed in all hospitals in the region Thus both politicians as well as patient organizations have an increased focus on involving the patients more engagement
Shared Decision Making - a possible game changer According to the Danish Melanoma Group approximately 100 patients are eligible for adjuvant treatment annually at the Department of Oncology Odense University Hospital Patients and physicians face the difficulties described above when having to decide which melanoma patients are to receive adjuvant therapy Sometimes the choice may seem obvious because the patients may have a relatively high risk of recurrence In other situations where the patients have a low risk of recurrence or comorbidities which may make treatment with immunotherapy risky it is more complex In such cases SDM could be useful to support this preference-sensitive decision SDM is defined as an approach where clinicians and patients share the best available evidence when faced with the task of making decisions and where patients are supported to consider options to achieve informed preferences and in making treatment decisions that align with these preferences A Danish lung cancer study from 2019 showed that patients who had been engaged in SDM had lower decisional conflict and regret Furthermore they felt more confident about the decision and the process facilitated that patients values played a more central role in decision-making One way to increase the level of patient-perceived involvement and make the consultations in the outpatient clinic more uniform may be to use a patient decision aid PtDA to support shared decision-making If the patients experience that they are part of the decision process it may also result in a lower level of decisional regret as described above
Patient Decision Aids In other countries such as the United States decision-support tools have been developed containing information on what the patients need to know about stage III melanoma The patients can find information about the disease substages adjuvant therapy vs active surveillance side effects and outcomes With this information in mind the patients may be able to weigh the options with their treating oncologist to come to the right decision Only a few decision aids have been developed and tested scientifically in a Danish context As mentioned adjuvant therapy as standard treatment is a relatively new treatment option for patients with melanoma and no recipe guidesdescribes how to reach the right shared decision for the individual patient However a study carried out in oncology care and pulmonary medicine demonstrates how the use of a patient decision aid PtDA enhanced SDM in two different settings and helped increase focus on patient preferences 25 This study used a generic patient decision aid template called Decision Helper developed by the Center for Shared Decision Making in the Region of Southern Denmark CFFB Therefore the center now offers a platform for decision-aid templates that adhere to the certification and quality criteria set by the International Patient Decision Aid Standards IPDAS Utilizing log-in healthcare providers have access to the platform and the template for building patient decision aids BESLUTNINGSHJÆLPER and will be able to build and develop PtDAs tailored to their specific needs The template is developed based on the IPDAS criteria
Study 1 - Development of the Patient Decision Aid
Methods As both patients and clinicians are the end-users of the PtDA both groups will participate in an iterative process to ensure that patient needs are prioritized and that the PtDA is relevant accurate and easy to use Thus instead of just seeing the patients as a source of data they will play an active role in the design phase of the PtDA A qualitative approach will be applied using semi-structured interviews as recommended in IPDAS guidelines where melanoma patients and clinicians will identify the type and amount of information needed for creating relevant and appropriate PtDA As a supplement to this another qualitative method observational will be used as a researcher the project manager will observe the patient-clinician communication before the introduction of the PtDA in a natural situation to collect data on the communication between the patient and clinician how the talk is organized and the level of patient involvement
Phase 1 Preparation of the Patient Decision Aid
Observation by researcher in the outpatient clinic - 5 consultations
An expert group consisting of physicians and nurses will look at PROs and CONs for receiving treatmentnot receiving treatment
Interviews with melanoma patients who have already decided whether to receive treatment or not about their views and preferences and what they see as advantages and disadvantages An interview guide will be prepared to ensure uniformity and all aspects are covered Three patients who have accepted treatment and three patients who have declined will be included
Phase 2 Design of the Patient Decision Aid
The PtDA will be prepared following the views and preferences of patients and clinicians with the following content
Introduction It must be clear to the patients that a PtDA is used in the consultation for the patient and the clinician to make a decision together
The choices must be clear to the patient observation or treatment
Focus on patient preferences - what matters to the patient
Description of the different choices using 4 cards describing
PROs and CONsrisks and benefits
Patient stories patients who have made the choice already see phase 1
Statistics risk of relapse
Timeline Description of the trajectory for both choices treatment or observation
Data entered into IT platform 1 Draft prepared Informationdata from phase 2 is entered into the IT platform BESLUTNINGSHJÆLPER and the first draft is ready The Center of Shared Decision-Making will provide support and feedback
User test - 2 draft prepared A user test is carried out including individual interviews with 3-4 patients and 3-4 clinicians For the patients a semi-structured interview guide will be used that is based on the items from the Preparation for Decision-Making Scale Similarly a guide will be prepared for clinicians Based on the findings from the interviews and usability testing the decision helper will be refined and changes will be entered into the IT platform
Trial period - 3 draft prepared The final version is printed and a trial period of approximately 12 weeks will take place If no further adjustments are required the PtDA is ready for implementation
Study 2 - Evaluation of the PtDA Hypothesis The implementation of the PtDA will result in an increased level of patient involvement among melanoma patients eligible for adjuvant immunotherapy In addition the patients will experience less decisional regret Moreover the consultations in the outpatient clinic will become more uniform and consistent
Aims To investigate 1the level of patient involvement and 2decisional regret among melanoma patients receiving adjuvant therapy before and after implementation of the PtDA In addition 3 to examine if the consultations become more uniform and consistent
Methods Since the aim was to examine the level of patient involvement decisional regret and the uniformity and consistency of consultations before and after the implementation of the PtDA it has been decided to use a pre-post study design Although this design does not take other factors that may change during the study into account it may be able to suggest if the outcome is impacted by the intervention A mixed method approach will be used to evaluate the effect of the PtDA using both quantitative data and the Decision Regret Scale and qualitative data individual interviews and focus group interviews A convergent design is selected in which survey data and interview data are collected in parallel over the same period This will be described in more detail for each of the three aims in the following
- Level of patient involvement Qualitative data The level of patient involvement will be examined using a qualitative approach by conducting interviews with eligible patients before and after implementation Due to the exploratory nature of the study the sample size cannot be determined in advance but the aim is to include 10-15 patients for both pre and post-interviews depending on when data saturation has been reached A purposive sample of patients will be selected to ensure maximal variation in gender age and treatment choice A semi-structured interview guide will be designed to make the interaction as smooth as possible and the interviews will carried out by the same interviewer to ensure uniformity Members of the project group will participate in the coding and analysis of the interviews Braun and Clarke six step theory will be used for analysis
Quantitative data
Qualitative data Focus group interviews will be carried out with clinicians who take part in outpatient consultations before and after implementation to elucidate if the consultations have become more uniform and consistent after the inclusion of the PtDA Due to the limited number of physicians and nurses caring fortreating the patient population it will only be possible to carry out two focus group interviews before and after The interviews will consist of approximately 5-6 clinicians each As with the individual interviews an interview guide will be prepared and the interviews conducted in a semi-structured manner The same content analysis approach will be applied to the group interview as described above
Quantitative data The plan is to measure the time spent on the individual consultation to elucidate if the time consumption differs between the two groups ie if the length of the consultations has been more uniform after implementation
- Decision regret Quantitative data Patients who have not been exposed to SDM pre-implementation and patients who have been exposed post-implementation will be asked to complete the Decision Regret Scale DRS The DRS is a questionnaire that measures distress and remorse after a healthcare decision The scale consists of 5 questions The scores are converted into a 0-100 scale following the user manual A score of 0 means no regret a score of 100 means high regret
Statistics
Primary outcome DRS 0-100 scale 20 steps mean beforeafter compared by linear regression with bootstrapped standard errors To take into account non-normality of scores Secondary analysis Tested with Wilcoxon rank-sum test Secondary outcomes DRS above cutoffs for mild 5-25 respectively moderatestrong regrets 30 Compared by logistic regression
Supplementary analysis In supplementary analyses above regressions will be adjusted for patient characteristics which might have changed between the before and after periods
Sample size calculations
Collaborators The study is supported by the head of department at the Department of Oncology at Odense University Hospital Two patient representatives and the team physicians and nurses that is responsible for the treatment will play a vital part in developing the PtDA to ensure that all aspects are covered Furthermore the study will be carried out in collaboration with The Center for Shared Decision-Making Finally a cross-sectional survey including various questionnaires was sent out to 427 melanoma patients across Denmark in March this year The Decision Regret Scale DRS is one of the questionnaires in the survey and accordingly it will be elucidated if the patients who have received adjuvant treatment in 2019 and 2020 have had any decisional regret The results will be helpful as historical background data for our project
Perspectives The studies will be based at the Department of Oncology OUH but the project is highly relevant for all melanoma patients in Denmark It is expected to change how outpatient consultations take place enabling the patients to participate in important decision-making regarding their treatment and care It is currently not well understood how patients eligible for adjuvant immunotherapy make their decision to accept or not accept treatment It is expected that the PtDA for melanoma patients receiving immunotherapy in the adjuvant setting can be used nationwide and serve as an example for other researchersclinicians who wish to design a similar tool for other patient populations receiving immunotherapy Moreover because the researchers also aim to evaluate the tool by comparing the level of patient involvement before and after implementation of the Decision Helper it will be elucidated if the designed tool makes a difference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None