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Web-based Information Tool for People With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632850
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Poole Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Bournemouth University

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 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


Condition or disease Intervention/treatment
Advanced Pancreatic Cancer Other: web-based interactive tool

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Shared Decision-making: Investigating the Potential of an Interactive, Web-Based, Information Tool for People With Advanced Pancreatic Cancer
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Doctors
This is a group of oncologists who have experience in treatment deliberations with patients of advanced cancer.
Other: web-based interactive tool
an online tool to assist users in decision-making in choice of treatment for advanced cancer

Nurses
This is a group of clinical nurse specialists who have experience in treatment deliberations with patients of advanced cancer
Other: web-based interactive tool
an online tool to assist users in decision-making in choice of treatment for advanced cancer

Patients
this is a group of adult patients who have been diagnosed with advanced pancreatic cancer
Other: web-based interactive tool
an online tool to assist users in decision-making in choice of treatment for advanced cancer

Relatives
this is a group of adults who are involved in providing support for their loved ones who are diagnosed with advanced pancreatic cancer
Other: web-based interactive tool
an online tool to assist users in decision-making in choice of treatment for advanced cancer




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Usability: System Usability Scale (SUS) [ Time Frame: up to 2 weeks after using the web-based information tool ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The participants will be recruited from two settings

  1. NHS sites in England
  2. Pancreatic Cancer UK (PCUK) (for patients and relatives)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who are unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632850


Contacts
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Contact: Ejike T Ezeh +441202961733 eezeh@bournemouth.ac.uk
Contact: Janet Scammell, DNursSci +441202962751 jscammell@bournemouth.ac.uk

Locations
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United Kingdom
Royal Bournemouth and Christchurch Hospitals Recruiting
Bournemouth, United Kingdom
Contact: Research Office         
Contact    012029 ext 62376    ResearchOffice@rbch.nhs.uk   
Dorset County Hospital NHS Foundation Trust Not yet recruiting
Dorchester, United Kingdom
Contact: R&I         
Contact       research@dchft.nhs.uk   
Poole Hospital NHS Foundation Trust Recruiting
Poole, United Kingdom
Contact: Ejike Ezeh         
University Hospital Southampton NHS Foundation Trust Not yet recruiting
Southampton, United Kingdom
Contact: Ejike Ezeh         
Sponsors and Collaborators
Bournemouth University
Poole Hospital NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Bournemouth University:
Study Protocol  [PDF] June 22, 2018


Publications:
Gresham, G. Informed Decision Making for Patients with Advanced Pancreatic Cancer Considering Chemotherapy: Development and Evaluation of a Clinical Decision Aid for Patients. Université d'Ottawa/University of Ottawa, 2013.

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Responsible Party: Bournemouth University
ClinicalTrials.gov Identifier: NCT03632850    
Other Study ID Numbers: 252843
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bournemouth University:
pancreatic cancer
shared decision-making
decision aids
web-based decision tool
mixed methods
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases