Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03632850
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2018-07-25
Brief Title:
Web-based Treatment Information Tool for People With Advanced Pancreatic Cancer
Sponsor:
Bournemouth University
Organization:
Bournemouth University
Study Overview
Official Title:
Shared Decision-making Investigating the Potential of an Interactive Web-Based Information Tool for People With Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
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:
Pancreatic cancer PC is usually diagnosed at a late stage when it is incurable thereby limiting treatment to palliative care Chemotherapy is one of the standard palliative care options Due to the availability of different regimens with varying degrees of benefits and risks clinicians and patients with advanced pancreatic cancer usually discuss treatment options in order to arrive at the most appropriate chemotherapy regimen for the patient The use of information tools has produced positive results in explaining the benefits and risks of different treatment options for diseases like stage IV lung cancer ovarian cancer and colorectal cancer However there is no such tool for people with advanced pancreatic cancer With over 80 of people with pancreatic cancer being diagnosed in the advanced stage it would be beneficial to enhance effective decision-making with respect to treatment at this challenging time of the disease progression
The aim of this research is to investigate the potential of a web-based information tool to support decision-making about treatment options for people who have been diagnosed with advanced pancreatic cancer
A multiphase mixed methods design has been adopted for this research study The identified phases are 1 systematic review and network meta-analysis of reported randomised controlled trials RCTs in advanced pancreatic cancer 2 focus groupspersonal interviews with clinicians and semi-structured interviews with patients and their relatives 3 web-based information tool development and 4 pilot test of the developed information tool with clinicians patients and relatives of patients
The aim of this research is to investigate the potential of a web-based information tool to support decision-making about treatment options for people who have been diagnosed with advanced pancreatic cancer
A multiphase mixed methods design has been adopted for this research study The identified phases are 1 systematic review and network meta-analysis of reported randomised controlled trials RCTs in advanced pancreatic cancer 2 focus groupspersonal interviews with clinicians and semi-structured interviews with patients and their relatives 3 web-based information tool development and 4 pilot test of the developed information tool with clinicians patients and relatives of patients
Detailed Description:
Pancreatic cancer PC is a disease with very low 5-year survival rates Some estimates set this at less than 5 In the European Union EU over 85000 deaths were projected in 2017 which is a rise of around 80 from 2012 PC can be broadly classified as locally resectable borderline resectable locally advanced and metastatic Treatments include surgery chemotherapy radiation therapy and palliative care Surgery offers curative treatment but 80 of patients are diagnosed in the advanced stage locally advanced or metastatic and are ineligible However systemic therapy such as chemotherapy is a palliative option for people with advanced pancreatic cancer APC Best supportive care BSC or supportive care is another option which involves symptom management and improving quality of life
Shared decision-making SDM is a process where clinicians and patients make decisions together using the best available evidence SDM is recognised as a policy priority and ethical imperative by the National Health Service NHS and several healthcare regulators in the United Kingdom UK respectively The concept of equipoise is a scenario where there is more than one legitimate choice of treatment for a medical condition It offers an opportunity to apply SDM in discussing the choice of treatment for people with APC because there is no clear preference of treatment options in terms of benefits and risks for APC Moreover a systematic review in 2006 indicated among other things that SDM facilitated positive impact on the clinical process and patient outcomes Encouraging SDM in APC treatment could yield similar results including the reduction in selecting aggressive treatments that have little or no corresponding economic or personal benefits
Several tools have been developed to enhance SDM in relation to other medical conditions Some of these tools are for ovarian cancer stage IV lung cancer and colorectal cancer CONNECT is a computer-based tool that was developed for the general improvement of the doctor-patient communication process Additionally a systematic review in 2015 showed that decision tools can improve patients knowledge and awareness of the treatment options available to them However there is very little in literature about the use of evidence-based digital tools in discussing the expected outcomes of treatment for people with APC Although predictive tools have been developed for PC there is currently no web-based information tool that can provide clinical evidence on the treatment choices available to people with APC
However there is an online decision aid developed for patients with APC in Canada It has some useful features which can help its users make decisions about their treatment including information about APC However its automation in comparing treatment options is basic its depth of information necessary for decision-making and its flexibility could be improved Its target audience are the patients only It also assumes that users typically have only 3 options to choose from although it suggested the possibility of increasing the user options
It is necessary that patients are fully aware of the benefits and risks associated with any treatment that is being proposed to them Also to ensure that clinicians provide the best available evidence-based information in an easily understandable format for the patients the purpose of this study is to investigate the potential of an interactive web-based information tool to facilitate the process of shared decision-making between clinicians and patients and their relatives or caregivers
RESEARCH RATIONALE
1 The need for an evidence-based information tool for APC treatment options
There is currently no web-based SDM tool for APC that presents information on available treatment options in a visual and concise way to patients so that they and their clinicians can make informed choices Acceptability and reliability are two important factors to be considered when developing such tools
2 The support for the policy priority for patient-centred care in the UK
In the United Kingdom shared decision-making is viewed as a priority in patient care However effective SDM is enhanced through well-informed participants and that is an objective of the proposed information tool
3 Enhancing clinicians communicative skills
Communicative skills was identified in healthcare professionals as a requisite for successful SDM Therefore the proposed information tool is hoped to enhance clinicians capacity to communicate available treatment options with their patients by presenting pertinent facts about APC treatment in a concise and user-friendly manner for them
4 Improving medical cost-effectiveness This tool could also potentially challenge the more-is-better attitude assumption that expensive treatment equals better healthcare held by the public Evaluation of some patient decision aids showed improved cost-effectiveness in some medical conditions Introducing the information tool to APC treatment could potentially yield similar results
OBJECTIVES Primary objective To investigate the potential of a web-based interactive information tool in facilitating shared decision-making in the choice of treatment for people with advanced pancreatic cancer
Second objectives i To assess the quality of life efficacy and safety of chemotherapy treatments of APC through systematic review and network meta-analysis NMA of randomized controlled trials RCTs
ii To explore the preferences and expectations of clinicians people with APC and their relatives when making decisions about treatment through focus groups and semi-structured interviews for clinicians and people with APC including their relatives respectively
iii To identify the features necessary for the design of a web-based information tool to facilitate SDM between clinicians and people with APC about choice of treatment
iv To evaluate the effectiveness of the developed information tool in SDM through a pilot test with clinicians doctors and nurse specialists people with APC and their relatives
Shared decision-making SDM is a process where clinicians and patients make decisions together using the best available evidence SDM is recognised as a policy priority and ethical imperative by the National Health Service NHS and several healthcare regulators in the United Kingdom UK respectively The concept of equipoise is a scenario where there is more than one legitimate choice of treatment for a medical condition It offers an opportunity to apply SDM in discussing the choice of treatment for people with APC because there is no clear preference of treatment options in terms of benefits and risks for APC Moreover a systematic review in 2006 indicated among other things that SDM facilitated positive impact on the clinical process and patient outcomes Encouraging SDM in APC treatment could yield similar results including the reduction in selecting aggressive treatments that have little or no corresponding economic or personal benefits
Several tools have been developed to enhance SDM in relation to other medical conditions Some of these tools are for ovarian cancer stage IV lung cancer and colorectal cancer CONNECT is a computer-based tool that was developed for the general improvement of the doctor-patient communication process Additionally a systematic review in 2015 showed that decision tools can improve patients knowledge and awareness of the treatment options available to them However there is very little in literature about the use of evidence-based digital tools in discussing the expected outcomes of treatment for people with APC Although predictive tools have been developed for PC there is currently no web-based information tool that can provide clinical evidence on the treatment choices available to people with APC
However there is an online decision aid developed for patients with APC in Canada It has some useful features which can help its users make decisions about their treatment including information about APC However its automation in comparing treatment options is basic its depth of information necessary for decision-making and its flexibility could be improved Its target audience are the patients only It also assumes that users typically have only 3 options to choose from although it suggested the possibility of increasing the user options
It is necessary that patients are fully aware of the benefits and risks associated with any treatment that is being proposed to them Also to ensure that clinicians provide the best available evidence-based information in an easily understandable format for the patients the purpose of this study is to investigate the potential of an interactive web-based information tool to facilitate the process of shared decision-making between clinicians and patients and their relatives or caregivers
RESEARCH RATIONALE
1 The need for an evidence-based information tool for APC treatment options
There is currently no web-based SDM tool for APC that presents information on available treatment options in a visual and concise way to patients so that they and their clinicians can make informed choices Acceptability and reliability are two important factors to be considered when developing such tools
2 The support for the policy priority for patient-centred care in the UK
In the United Kingdom shared decision-making is viewed as a priority in patient care However effective SDM is enhanced through well-informed participants and that is an objective of the proposed information tool
3 Enhancing clinicians communicative skills
Communicative skills was identified in healthcare professionals as a requisite for successful SDM Therefore the proposed information tool is hoped to enhance clinicians capacity to communicate available treatment options with their patients by presenting pertinent facts about APC treatment in a concise and user-friendly manner for them
4 Improving medical cost-effectiveness This tool could also potentially challenge the more-is-better attitude assumption that expensive treatment equals better healthcare held by the public Evaluation of some patient decision aids showed improved cost-effectiveness in some medical conditions Introducing the information tool to APC treatment could potentially yield similar results
OBJECTIVES Primary objective To investigate the potential of a web-based interactive information tool in facilitating shared decision-making in the choice of treatment for people with advanced pancreatic cancer
Second objectives i To assess the quality of life efficacy and safety of chemotherapy treatments of APC through systematic review and network meta-analysis NMA of randomized controlled trials RCTs
ii To explore the preferences and expectations of clinicians people with APC and their relatives when making decisions about treatment through focus groups and semi-structured interviews for clinicians and people with APC including their relatives respectively
iii To identify the features necessary for the design of a web-based information tool to facilitate SDM between clinicians and people with APC about choice of treatment
iv To evaluate the effectiveness of the developed information tool in SDM through a pilot test with clinicians doctors and nurse specialists people with APC and their relatives
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