Web-based Treatment Information Tool for People With Advanced Pancreatic Cancer

NCT03632850 | Completed

• 1 other identifier: 252843
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 4

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

Conditions

Advanced Pancreatic Cancer

Keywords

pancreatic cancer; shared decision-making; decision aids; web-based decision tool; mixed methods

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 weeks after using the web-based information tool

Secondary Outcomes (1)

• Usability: System Usability Scale (SUS)

  up to 2 weeks after using the web-based information tool

Study Arms (4)

Doctors

This is a group of oncologists who have experience in treatment deliberations with patients of advanced cancer.

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

Other: web-based interactive tool

Patients

this is a group of adult patients who have been diagnosed with advanced pancreatic cancer

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

Other: web-based interactive tool

Interventions

web-based interactive tool OTHER

an online tool to assist users in decision-making in choice of treatment for advanced cancer

Doctors; Nurses; Patients; Relatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Patients who are unable to provide informed consent

Sponsors & Collaborators

• Bournemouth University: lead
• Poole Hospital NHS Foundation Trust: collaborator

Study Sites (4)

Royal Bournemouth and Christchurch Hospitals

Bournemouth, United Kingdom

Location

Dorset County Hospital NHS Foundation Trust

Dorchester, United Kingdom

Location

Poole Hospital NHS Foundation Trust

Poole, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

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MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 16, 2018
• Study Start: February 19, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)