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

NCT ID: NCT04852809

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-18

Study Completion Date

2022-03-10

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Questionnaire

Observational

No intervention

Intervention Type OTHER

This is an observational study

Focus Group

Observational

No intervention

Intervention Type OTHER

This is an observational study

Interventions

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No intervention

This is an observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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CFTSp197

Identifier Type: -

Identifier Source: org_study_id

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