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Pelvic Radiation Disease in Childhood Cancer Survivors

NCT05533541 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-11-08

No results posted yet for this study

Summary

This study aims to characterise the impact of radiotherapy on physical symptoms and quality of life in childhood and young adult cancer survivors. This is in line with current NHS strategic priorities and an unmet clinical need to optimise aftercare in this patient group. In order to provide effective treatment strategies, the scale and impact of symptom burden requires better characterisation.

A significant proportion of adult patients suffer with gastrointestinal and urinary symptoms and sexual dysfunction following radiotherapy treatment. However there is a lack of data in the paediatric and young adult population.

We will study patients who underwent abdomino-pelvic radiotherapy, who completed treatment between 2000 and 2021 and were under the age of 24 years at the time of treatment. Patients will be recruited from The Royal Marsden Hospital, Great Ormond St Hospital and University College Hospital.

Once these patients are identified we propose to prospectively assess severity of their ongoing symptoms using an electronic questionnaire, including relevant extracts from existing validated questionnaires. Treatment and patient related factors will be extracted from patient hospital records.

A further qualitative arm of the study will be completed on a sub-set of 10 patients. We will identify appropriate patients that are willing to participate in qualitative research at the time of consenting. One-to-one interviews will be conducted to gain a better insight into their symptom burden, quality of life, patient perceptions of current services and view of currently unmet needs.

This study will provide novel data on the frequency and severity of gastrointestinal and bladder related radiotherapy toxicity in young adult cancer survivors and assess impact on sexual function and quality of life. We would then propose to use this data to focus on service improvements within the regional paediatric and TYA cancer aftercare service driven by patient experience and clinical need.

Conditions

  • Radiation Disease

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Henry C Mandeville, MBChB/MDRes · The Royal Marsden Hospital

Eligibility

Max Age
46 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05533541 on ClinicalTrials.gov