Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date July 25, 2018
First Posted Date August 16, 2018
Last Update Posted Date January 14, 2020
Actual Study Start Date February 19, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 15, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Web-based Information Tool for People With Advanced Cancer
Official Title Shared Decision-making: Investigating the Potential of an Interactive, Web-Based, Information Tool for People With Advanced Pancreatic Cancer
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

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

  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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Advanced Pancreatic Cancer
Intervention Other: web-based interactive tool
an online tool to assist users in decision-making in choice of treatment for advanced cancer
Study Groups/Cohorts
  • Doctors
    This is a group of oncologists who have experience in treatment deliberations with patients of advanced cancer.
    Intervention: 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
    Intervention: Other: web-based interactive tool
  • Patients
    this is a group of adult patients who have been diagnosed with advanced pancreatic cancer
    Intervention: 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
    Intervention: Other: web-based interactive tool
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 15, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ejike T Ezeh +441202961733 eezeh@bournemouth.ac.uk
Contact: Janet Scammell, DNursSci +441202962751 jscammell@bournemouth.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03632850
Other Study ID Numbers 252843
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bournemouth University
Study Sponsor Bournemouth University
Collaborators Poole Hospital NHS Foundation Trust
Investigators Not Provided
PRS Account Bournemouth University
Verification Date January 2020