Pelvic Radiation Disease in Childhood Cancer Survivors

NCT05533541 | Unknown

• 1 other identifier: CCR5420
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary End point

  Proportion of childhood cancer survivors treated with abdominal or pelvic radiotherapy that develop gastrointestinal, urinary or sexual dysfunction.

  2 years

Secondary Outcomes (4)

• Secondary End point 1

  2 years

• Secondary End point 2

  2 years

• Secondary End point 3

  2 years

• Secondary End point 4

  2 years

Eligibility Criteria

• Age: Up to 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The proposed population for the study will be patients who received abdominal and/or pelvic radiotherapy and completed treatment between 2000 and 2021. They will have been under 24 years of age at the time of treatment. They will have been treated at The Royal Marsden Hospital, Great Ormond St Hospital or University College Hospital which are the three paediatric London-based Principal Treatment Centres (PTCs).

You may qualify if:

• Patients who;
• Were treated at The Royal Marsden Hospital, Great Ormond St Hospital or University College Hospital.
• Received radical radiotherapy to the abdomen and / or pelvis
• Were treated at age 24 years or below
• Completed treatment between 2000 - 2021.

You may not qualify if:

• Patients who;
• Received total body irradiation (TBI) or spinal radiation
• Have died, moved abroad or cannot be contacted.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• University College London Hospitals: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Abnormalities, Radiation-Induced

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Radiation Injuries; Wounds and Injuries

Study Officials

• Henry C Mandeville, MBChB/MDRes

  The Royal Marsden Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula LB Adkin, MBBS/BSc

CONTACT

0208 915 6475; paula.adkin@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: October 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

GB (1)