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NCT Number: NCT04852809

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Patients have to be 18 years of age or older.
  • 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:

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

Treatment and study plan

No intervention

Other

This is an observational study

Primary outcomes

  1. To evaluate patients' attitudes to technology in the clinical trial setting since the coronavirus pandemic 2020.

    Time frame: 9 months

Secondary outcomes

  1. To assess changes in patients use of technology in oncology clinical trials prior to and since the coronavirus pandemic 2020.

    Time frame: 9 months

Other outcomes

  1. To determine how coronavirus pandemic has impacted the use of technology in the delivery of oncology trials for patients.

    Time frame: 9 months

  2. To assess the relationship between socioeconomic status and age and how it impacts the use of technology

    Time frame: 9 months

  3. To evaluate the challenges and opportunities of using technology in the future in the delivery of clinical trials technologies for future patient care.

    Time frame: 9 months

  4. To assess the role of healthcare technologies for future patient care.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: CONNECT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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