COvid-19 aNd TechNology - thE Impact on Clinical Trial Patients

Completed

• Conditions: Cancer
• Interventions: Other: No intervention

• Registration Number: NCT04852809
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Study Start: 2021-05-18
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Questionnaire	No intervention	Observational
Focus Group	No intervention	Observational

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom