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Background <p>Locally recurrent rectal cancer (LRRC) is an emerging area for research; however, it represents significant challenges as a relatively rare form of advanced pelvic malignancy, from both a recruitment and study setup and delivery perspective. To date, there have been relatively few published trials in this setting. High-quality, multi-centre, prospective studies could offer helpful insights regarding the challenges associated with delivering studies in rare disease settings such as LRRC, and how to effectively address them.</p> Methods <p>The Locally Recurrent Rectal Cancer—Quality of Life (LRRC-QoL) study is an international, multi-centre, mixed-methods study of health-related quality of life (HrQoL) in LRRC. The International Surgical Trials Toolkit was utilised as a guideline in navigating site setup processes and to describe the challenges encountered during this study. A modified Quintet Recruitment Intervention (QRI) was used as a framework to identify recruitment challenges and drive improvements.</p> Results <p>Overall, 227 patients were recruited to the LRRC-QoL study across 14 countries. Significant challenges were encountered during site setup, including issues related to legal agreements which were further complicated by Brexit, expenses related to translation, and requirements for multiple ethical approvals. Delays during study setup and recruitment challenges occurred due to the COVID-19 pandemic. Several strategies were identified through the modified QRI with a positive impact on recruitment. Recruitment pathways were refined to a more streamlined, centralised approach, facilitated by verbal consent to contact. Recruitment rates also improved with the introduction of multiple options for participation, including traditional paper-based methods, online, and via telephone. Patient information leaflets were refined following patient and public involvement (PPI) work.</p> Conclusions <p>Several approaches identified during the LRRC-QoL study should be considered in the development of future studies and trials recruiting patients with LRRC. These include undertaking PPI during study development, identifying flexible recruitment strategies which complement sites’ existing clinical processes, and partnering with existing collaborative networks.</p> <p>Study registration</p> <p>The LRRC-QoL study registration reference: ISRCTN13692671 (<a href="https://doi.org/10.1186/ISRCTN13692671">https://doi.org/10.1186/ISRCTN13692671</a>).</p>

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Challenges and strategies to improve recruitment in international, multi-centre research studies in locally recurrent rectal cancer: experience from the Locally Recurrent Rectal Cancer—Quality of Life (LRRC-QoL) study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月25日

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  • Niamh McKigney,
  • Julie Croft,
  • Galina Velikova,
  • Julia M. Brown,
  • Deena P. Harji

摘要

Background

Locally recurrent rectal cancer (LRRC) is an emerging area for research; however, it represents significant challenges as a relatively rare form of advanced pelvic malignancy, from both a recruitment and study setup and delivery perspective. To date, there have been relatively few published trials in this setting. High-quality, multi-centre, prospective studies could offer helpful insights regarding the challenges associated with delivering studies in rare disease settings such as LRRC, and how to effectively address them.

Methods

The Locally Recurrent Rectal Cancer—Quality of Life (LRRC-QoL) study is an international, multi-centre, mixed-methods study of health-related quality of life (HrQoL) in LRRC. The International Surgical Trials Toolkit was utilised as a guideline in navigating site setup processes and to describe the challenges encountered during this study. A modified Quintet Recruitment Intervention (QRI) was used as a framework to identify recruitment challenges and drive improvements.

Results

Overall, 227 patients were recruited to the LRRC-QoL study across 14 countries. Significant challenges were encountered during site setup, including issues related to legal agreements which were further complicated by Brexit, expenses related to translation, and requirements for multiple ethical approvals. Delays during study setup and recruitment challenges occurred due to the COVID-19 pandemic. Several strategies were identified through the modified QRI with a positive impact on recruitment. Recruitment pathways were refined to a more streamlined, centralised approach, facilitated by verbal consent to contact. Recruitment rates also improved with the introduction of multiple options for participation, including traditional paper-based methods, online, and via telephone. Patient information leaflets were refined following patient and public involvement (PPI) work.

Conclusions

Several approaches identified during the LRRC-QoL study should be considered in the development of future studies and trials recruiting patients with LRRC. These include undertaking PPI during study development, identifying flexible recruitment strategies which complement sites’ existing clinical processes, and partnering with existing collaborative networks.

Study registration

The LRRC-QoL study registration reference: ISRCTN13692671 (https://doi.org/10.1186/ISRCTN13692671).