Advanced Pancreatic CancerNCT03632850
Web-based Treatment Information Tool for People With Advanced Pancreatic Cancer
An observational study of Advanced Pancreatic Cancer, run by Bournemouth University at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- web-based interactive tool
- How many people
- 34 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 19 Feb 2019to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants will be recruited from two settings 1. NHS sites in England 2. Pancreatic Cancer UK (PCUK) (for patients and relatives)
Who may be able to join
- Doctors and nurses must have had experience of a minimum of one consultation with a patient with cancer leading to the administration of chemotherapy
- Patients Diagnosed with advanced pancreatic cancer, Able to speak and understand written English, 18 years or older
- Relatives must be involved in, or aware of, the decision of the patients in choice of treatment, should be responsible for the provision of support to the patient, 18 years or older, Able to speak and understand written English
Who cannot join
- Patients who are unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Royal Bournemouth and Christchurch Hospitals
Bournemouth
Dorset County Hospital NHS Foundation Trust
Dorchester
Poole Hospital NHS Foundation Trust
Poole
University Hospital Southampton NHS Foundation Trust
Southampton
About this study
Official title: Shared Decision-making: Investigating the Potential of an Interactive, Web-Based, Information Tool for People With Advanced Pancreatic Cancer
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 groups/personal 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
Read the 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 85,000 deaths were projected in 2017, which is a rise of around 8.0% 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
- 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.
- 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.
- 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.
- 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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- web-based interactive tool
- Keywords
- pancreatic cancer, shared decision-making, decision aids, web-based decision tool, mixed methods
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based interactive toolOther
an online tool to assist users in decision-making in choice of treatment for advanced cancer
| Study group | Role | What they receive |
|---|---|---|
| Doctors | This is a group of oncologists who have experience in treatment deliberations with patients of advanced cancer. Receives: Other: web-based interactive tool | |
| Nurses | This is a group of clinical nurse specialists who have experience in treatment deliberations with patients of advanced cancer Receives: Other: web-based interactive tool | |
| Patients | this is a group of adult patients who have been diagnosed with advanced pancreatic cancer Receives: Other: web-based interactive tool | |
| Relatives | this is a group of adults who are involved in providing support for their loved ones who are diagnosed with advanced pancreatic cancer Receives: Other: web-based interactive tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
this is a 16-item validated instrument that measures the effectiveness in, and perceptions around decision making, using the decisional conflict construct, which is a state of uncertainty about the course of action to take. Subscales in the instrument are Informed subscale (3 items), Values Clarity subscale (3 items), Support subscale (3 items), and uncertainty subscale (4 items). The individual score is converted to an equivalent 0-100 scale. A total high score (above 37.5) means a high decisional conflict indicating a poor decision-making outcome, while a score below 25 indicates low decisional conflict hence better decision-making outcome. Mean scores and standard deviations will be reported for this measure.
Measured: up to 2 weeks after using the web-based information tool
Secondary outcomes (1)
Usability: System Usability Scale (SUS)
a measure of the usability of the web-based information tool based on adaptions of the System Usability Scale (SUS).
This is a 10-item scale with 5 responses per item that measures the ease of use of a system. The scoring involves conversion of the responses to a scale of 100. Scores of 68 or above termed as "above average", while those below 68 are "below average". However, normalization will be done to obtain percentile ranking for the group under investigation.
Measured: up to 2 weeks after using the web-based information tool
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start19 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Poole Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632850
- Sponsor's protocol ID
- 252843
- Status last verified
- Oct 2021
- First submitted
- 25 Jul 2018
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. Lancet. 2011 Aug 13;378(9791):607-20. doi: 10.1016/S0140-6736(10)62307-0. Epub 2011 May 26.
PubMed 21620466Balaban EP, Mangu PB, Khorana AA, Shah MA, Mukherjee S, Crane CH, Javle MM, Eads JR, Allen P, Ko AH, Engebretson A, Herman JM, Strickler JH, Benson AB 3rd, Urba S, Yee NS. Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2016 Aug 1;34(22):2654-68. doi: 10.1200/JCO.2016.67.5561. Epub 2016 May 31.
PubMed 27247216Malvezzi M, Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2017, with focus on lung cancer. Ann Oncol. 2017 May 1;28(5):1117-1123. doi: 10.1093/annonc/mdx033.
PubMed 28327906Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
PubMed 26830752Ducreux M, Cuhna AS, Caramella C, Hollebecque A, Burtin P, Goere D, Seufferlein T, Haustermans K, Van Laethem JL, Conroy T, Arnold D; ESMO Guidelines Committee. Cancer of the pancreas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v56-68. doi: 10.1093/annonc/mdv295. No abstract available.
PubMed 26314780Taieb J, Pointet AL, Van Laethem JL, Laquente B, Pernot S, Lordick F, Reni M. What treatment in 2017 for inoperable pancreatic cancers? Ann Oncol. 2017 Jul 1;28(7):1473-1483. doi: 10.1093/annonc/mdx174.
PubMed 28459988Hui D, De La Cruz M, Mori M, Parsons HA, Kwon JH, Torres-Vigil I, Kim SH, Dev R, Hutchins R, Liem C, Kang DH, Bruera E. Concepts and definitions for "supportive care," "best supportive care," "palliative care," and "hospice care" in the published literature, dictionaries, and textbooks. Support Care Cancer. 2013 Mar;21(3):659-85. doi: 10.1007/s00520-012-1564-y. Epub 2012 Aug 31.
PubMed 22936493Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. BMJ. 2010 Oct 14;341:c5146. doi: 10.1136/bmj.c5146. No abstract available.
PubMed 20947577Coulter A, Edwards A, Entwistle V, Kramer G, Nye A, Thomson R, Walker E. Shared decision making in the UK: Moving towards wider uptake. Z Evid Fortbild Qual Gesundhwes. 2017 Jun;123-124:99-103. doi: 10.1016/j.zefq.2017.05.010. Epub 2017 May 20.
PubMed 28532629Edwards A, Hood K, Matthews E, Russell D, Russell I, Barker J, Bloor M, Burnard P, Covey J, Pill R, Wilkinson C, Stott N. The effectiveness of one-to-one risk communication interventions in health care: a systematic review. Med Decis Making. 2000 Jul-Sep;20(3):290-7. doi: 10.1177/0272989X0002000305.
PubMed 10929851Elwyn G, Edwards A, Kinnersley P, Grol R. Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices. Br J Gen Pract. 2000 Nov;50(460):892-9.
PubMed 11141876Gravel K, Legare F, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: a systematic review of health professionals' perceptions. Implement Sci. 2006 Aug 9;1:16. doi: 10.1186/1748-5908-1-16.
PubMed 16899124Oshima Lee E, Emanuel EJ. Shared decision making to improve care and reduce costs. N Engl J Med. 2013 Jan 3;368(1):6-8. doi: 10.1056/NEJMp1209500. No abstract available.
PubMed 23281971Veroff D, Marr A, Wennberg DE. Enhanced support for shared decision making reduced costs of care for patients with preference-sensitive conditions. Health Aff (Millwood). 2013 Feb;32(2):285-93. doi: 10.1377/hlthaff.2011.0941.
PubMed 23381521Elwyn G, Rasmussen J, Kinsey K, Firth J, Marrin K, Edwards A, Wood F. On a learning curve for shared decision making: Interviews with clinicians using the knee osteoarthritis Option Grid. J Eval Clin Pract. 2018 Feb;24(1):56-64. doi: 10.1111/jep.12665. Epub 2016 Nov 16.
PubMed 27860101
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-making: Investigating the Potential of an Interactive, Web-Based, Information Tool for People With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03632850
- Acronym / sponsor ID
- 252843
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- pancreatic cancer, shared decision-making, decision aids, web-based decision tool, mixed methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Poole Hospital NHS Foundation Trust
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 groups/personal 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 85,000 deaths were projected in 2017, which is a rise of around 8.0% 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
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Doctors | – | Other: web-based interactive toolThis is a group of oncologists who have experience in treatment deliberations with patients of advanced cancer. |
| Nurses | – | Other: web-based interactive toolThis is a group of clinical nurse specialists who have experience in treatment deliberations with patients of advanced cancer |
| Patients | – | Other: web-based interactive toolthis is a group of adult patients who have been diagnosed with advanced pancreatic cancer |
| Relatives | – | Other: web-based interactive toolthis is a group of adults who are involved in providing support for their loved ones who are diagnosed with advanced pancreatic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited from two settings 1. NHS sites in England 2. Pancreatic Cancer UK (PCUK) (for patients and relatives)
Key inclusion criteria (3 listed)
- Doctors and nurses must have had experience of a minimum of one consultation with a patient with cancer leading to the administration of chemotherapy
- Patients Diagnosed with advanced pancreatic cancer, Able to speak and understand written English, 18 years or older
- Relatives must be involved in, or aware of, the decision of the patients in choice of treatment, should be responsible for the provision of support to the patient, 18 years or older, Able to speak and understand written English
Key exclusion criteria (1 listed)
- Patients who are unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based interactive toolan online tool to assist users in decision-making in choice of treatment for advanced cancer | Other | Doctors, Nurses, Patients, Relatives |
Primary outcome
Decisional Conflict Scale
Time frame: up to 2 weeks after using the web-based information tool
this is a 16-item validated instrument that measures the effectiveness in, and perceptions around decision making, using the decisional conflict construct, which is a state of uncertainty about the course of action to take. Subscales in the instrument are Informed subscale (3 items), Values Clarity subscale (3 items), Support subscale (3 items), and uncertainty subscale (4 items). The individual score is converted to an equivalent 0-100 scale. A total high score (above 37.5) means a high decisional conflict indicating a poor decision-making outcome, while a score below 25 indicates low decisional conflict hence better decision-making outcome. Mean scores and standard deviations will be reported for this measure.
1 secondary outcome
Usability: System Usability Scale (SUS)
Time frame: up to 2 weeks after using the web-based information tool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 21620466Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. Lancet. 2011 Aug 13;378(9791):607-20. doi: 10.1016/S0140-6736(10)62307-0. Epub 2011 May 26.
- Background: PubMed 27247216Balaban EP, Mangu PB, Khorana AA, Shah MA, Mukherjee S, Crane CH, Javle MM, Eads JR, Allen P, Ko AH, Engebretson A, Herman JM, Strickler JH, Benson AB 3rd, Urba S, Yee NS. Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2016 Aug 1;34(22):2654-68. doi: 10.1200/JCO.2016.67.5561. Epub 2016 May 31.
- Background: PubMed 28327906Malvezzi M, Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2017, with focus on lung cancer. Ann Oncol. 2017 May 1;28(5):1117-1123. doi: 10.1093/annonc/mdx033.
- Background: PubMed 26830752Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
- Background: PubMed 26314780Ducreux M, Cuhna AS, Caramella C, Hollebecque A, Burtin P, Goere D, Seufferlein T, Haustermans K, Van Laethem JL, Conroy T, Arnold D; ESMO Guidelines Committee. Cancer of the pancreas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v56-68. doi: 10.1093/annonc/mdv295. No abstract available.
- Background: PubMed 28459988Taieb J, Pointet AL, Van Laethem JL, Laquente B, Pernot S, Lordick F, Reni M. What treatment in 2017 for inoperable pancreatic cancers? Ann Oncol. 2017 Jul 1;28(7):1473-1483. doi: 10.1093/annonc/mdx174.
- Background: PubMed 22936493Hui D, De La Cruz M, Mori M, Parsons HA, Kwon JH, Torres-Vigil I, Kim SH, Dev R, Hutchins R, Liem C, Kang DH, Bruera E. Concepts and definitions for "supportive care," "best supportive care," "palliative care," and "hospice care" in the published literature, dictionaries, and textbooks. Support Care Cancer. 2013 Mar;21(3):659-85. doi: 10.1007/s00520-012-1564-y. Epub 2012 Aug 31.
- Background: PubMed 20947577Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. BMJ. 2010 Oct 14;341:c5146. doi: 10.1136/bmj.c5146. No abstract available.
- Background: PubMed 28532629Coulter A, Edwards A, Entwistle V, Kramer G, Nye A, Thomson R, Walker E. Shared decision making in the UK: Moving towards wider uptake. Z Evid Fortbild Qual Gesundhwes. 2017 Jun;123-124:99-103. doi: 10.1016/j.zefq.2017.05.010. Epub 2017 May 20.
- Background: PubMed 10929851Edwards A, Hood K, Matthews E, Russell D, Russell I, Barker J, Bloor M, Burnard P, Covey J, Pill R, Wilkinson C, Stott N. The effectiveness of one-to-one risk communication interventions in health care: a systematic review. Med Decis Making. 2000 Jul-Sep;20(3):290-7. doi: 10.1177/0272989X0002000305.
- Background: PubMed 11141876Elwyn G, Edwards A, Kinnersley P, Grol R. Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices. Br J Gen Pract. 2000 Nov;50(460):892-9.
- Background: PubMed 16899124Gravel K, Legare F, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: a systematic review of health professionals' perceptions. Implement Sci. 2006 Aug 9;1:16. doi: 10.1186/1748-5908-1-16.
- Individual participant dataSharing planned: No
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Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Not yet recruitingObservational study
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Pancreatic Cancer
Pancreatic Cancer, Advanced or Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Pancreatic Cancer, run by Bournemouth University at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (time frame: up to 2 weeks after using the web-based information tool). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632850, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.