COvid-19 aNd TechNology - thE Impact on Clinical Trial Patients (CONNECT)

The Utilisation of Technology and Its Impact on Clinical Trial Patient Care During the Coronavirus Pandemic 2020-2021

This is a 2 part qualitative study involving a questionnaire (part 1) and focus group discussions (part 2).

The purpose of the study is to evaluate how patients' attitudes to technology in the oncology clinical trials setting since the start of the Coronavirus pandemic in 2020, and to assess how their use of technology has changed during this time.

Part 1 of the study will be conducted via a self-report questionnaire to 100-140 cancer patients involved in clinical trials at The Christie NHS Foundation Trust over a 2 month period. Following this, three focus groups with a maximum of 8 participants in each group will take place to further assess patients' experiences with technology during the pandemic.

Participants may take part in part 1 or part 2 only, or in both.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: No intervention

Detailed Description

Clinical trial involvement is more resource-intensive than receiving standard of care treatment and often results in more frequent hospital visits for patients. To reduce the risk of patients to COVID-19, there has been a shift towards reducing on-site visits with increased use of technology e.g. virtual visits. Patients may have also been using devices at home to aid in their care, including digital devices, mobile applications, smart watches and, rarely, trial-specific devices, to monitor aspects of their own health.

Our project will explore the impact that the coronavirus pandemic has had on clinical trial patients and how they feel technology could help or create barriers in their future care.

In order to quantify how clinical trial visits have changed and to evaluate patient's attitudes to the increasing use of technology in clinical trials, we will be disseminating questionnaires to 100 patients currently on clinical trials over a 2 month period. We will follow these up with three virtual focus group discussions with 8 participants in each to delve further into patients' experiences.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants will all be clinical trial patients from The Christie NHS Foundation Trust who meet the eligibility criteria.

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Patients have to be 18 years of age or older.
2. Patients have to be currently enrolled on a phase I, II or III cancer related clinical trial within the Christie NHS Foundation Trust

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Unable to understand and converse in English for the focus group session.
2. Patient not currently involved in a phase I, II or III clinical trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Questionnaire; Observational	Other: No intervention; This is an observational study
Focus Group; Observational	Other: No intervention; This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate patients' attitudes to technology in the clinical trial setting since the coronavirus pandemic 2020.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess changes in patients use of technology in oncology clinical trials prior to and since the coronavirus pandemic 2020.	9 months

Other Outcome Measures

Outcome Measure	Time Frame
To determine how coronavirus pandemic has impacted the use of technology in the delivery of oncology trials for patients.	9 months
To assess the relationship between socioeconomic status and age and how it impacts the use of technology	9 months
To evaluate the challenges and opportunities of using technology in the future in the delivery of clinical trials technologies for future patient care.	9 months
To assess the role of healthcare technologies for future patient care.	9 months

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust

Publications and helpful links

Helpful Links

• HRA website for results summary

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CFTSp197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No