Prospective Evaluation of Gastrointestinal and Genitourinary Side Effects of Pelvic Radiotherapy

NCT05407116 | Unknown

• 1 other identifier: 2022-8347
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

Brief Summary

Most patients who have pelvic radiotherapy (RT) as a treatment for cancer experience some degree of acute gastrointestinal (GI) and genitourinary (GU) toxicities. If physicians can anticipate, identify, and correctly manage symptoms, they can significantly improve patients' quality of life (QoL). Our study plans to enroll patients receiving standard or hypo-fractionated curative pelvic RT for the first time at the MUHC Radiation Oncology clinic. Patients will complete, through a mobile application (Opal) and in real-time, electronic patient-reported outcomes (PROs) questionnaires about acute GI/GU toxicities and quality of life (QoL). The treating physician will fill in the traditional intra-treatment forms simultaneously. The project's overall goal is to provide intra-treatment assessment tools to collect clinical information more relevant to the patients, improve patients' QoL, and triage clinically significant toxicities more efficiently.

Conditions

Radiotherapy Side Effects

Keywords

PROs

Outcome Measures

Primary Outcomes (2)

• Feasibility of collecting PROs and CROs for GI and GU toxicities prospectively and in real-time in a busy tertiary care cancer centre.

  The attrition rate is well-defined as the number of patients who start reporting as a proportion of the number recruited, with causes of non-compliance. The questionnaire completion rate, which will be calculated as the number of questionnaires with at least five questions answered divided by the total number of potential questionnaires that could be administered through the study.

  18 weeks

• Assess the association between PRO and CROs over time

  The primary outcome measures for assessing the association between PROs and CROs by comparing PRO-CTCAE symptom scores and clinician-reported CTCAE scores. Each PRO-CTCAE Symptom will be considered as a separate outcome, and correlated with its corresponding CTCAE Version 5.0 Term:

  18 weeks

Secondary Outcomes (3)

• Exploring the influence of baseline characteristics on treatment-related GI and GU symptoms

  18 weeks

• Exploring the influence of baseline characteristics on health-related quality of life

  18 weeks

• Assess whether PRO/CRO scores are associated with subsequent patient healthcare outcomes (changes in medications, ER visits, hospital admissions)

  18 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Patients receiving standard or hypofractionated radiotherapy for curative intent to a pelvic malignancy with an intended total dose of 25-60 Gy.

Other: NCI PRO-CTCAE Questionnaire / EORTC QLQ-C30 Questionnaire

Interventions

NCI PRO-CTCAE Questionnaire / EORTC QLQ-C30 Questionnaire OTHER

PROs data will be collected prospectively via electronic questionnaires (PRO-CTCAE™), which is a patient-reported outcomes measurement system created to assess symptomatic toxicity in patients of cancer clinical research. PRO-CTCAE items evaluate frequency, severity, interference, amount, presence/absence symptoms. Each symptomatic adverse effect is measured by 1-3 features. GI items included nausea, vomiting, flatulence, bloating of the abdomen, constipation, diarrhea, abdominal pain, and loss of control of bowel movements. Urinary symptoms include the urge to urinate suddenly, frequency, urine colour change, loss of urine control (leakage). Patients will also self-report health-related quality of life (QoL) in real-time, electronic PRO questionnaires (EORTC QLQ CX24, EN 24, C30) about QoL. Question 29 and 30 ask the patients to rate their overall health and QOL respectively during the past week on a scale between 1-7, where one is equivalent to "very poor" and seven is "excellent."

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years or older
• Patients receiving standard or hypo-fractionated RT for curative intent to a pelvic malignancy
• Patients' ECOG performance status must be 0-2
• Patients should be able to give informed consent, read and understand English or French
• Patients should have access to the internet

You may not qualify if:

• Patients who have received prior pelvic radiation
• Patients who are at the end-of-life (expected survival less than six months)
• patients with significant cognitive dysfunction are excluded.
• patients included in other QoL studies, which may increase the patient burden and bias the answering of questionnaires

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Related Publications (9)

• Laugsand EA, Sprangers MA, Bjordal K, Skorpen F, Kaasa S, Klepstad P. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes. 2010 Sep 21;8:104. doi: 10.1186/1477-7525-8-104.

  PMID: 20858248 BACKGROUND

• Basch E, Jia X, Heller G, Barz A, Sit L, Fruscione M, Appawu M, Iasonos A, Atkinson T, Goldfarb S, Culkin A, Kris MG, Schrag D. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst. 2009 Dec 2;101(23):1624-32. doi: 10.1093/jnci/djp386. Epub 2009 Nov 17.

  PMID: 19920223 BACKGROUND

• Budischewski K, Fischbeck S, Mose S. Quality of life of breast cancer patients in the course of adjuvant radiotherapy. Support Care Cancer. 2008 Mar;16(3):299-304. doi: 10.1007/s00520-007-0321-0. Epub 2007 Aug 7.

  PMID: 17680279 BACKGROUND

• Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

  PMID: 28586821 BACKGROUND

• Yucel B, Akkas EA, Okur Y, Eren AA, Eren MF, Karapinar H, Babacan NA, Kilickap S. The impact of radiotherapy on quality of life for cancer patients: a longitudinal study. Support Care Cancer. 2014 Sep;22(9):2479-87. doi: 10.1007/s00520-014-2235-y. Epub 2014 Apr 12.

  PMID: 24728584 BACKGROUND

• Chorbinska J, Krajewski W, Zdrojowy R. Urological complications after radiation therapy-nothing ventured, nothing gained: a Narrative Review. Transl Cancer Res. 2021 Feb;10(2):1096-1118. doi: 10.21037/tcr-20-2589.

  PMID: 35116437 BACKGROUND

• Hafiz A, Abbasi AN, Ali N, Khan KA, Qureshi BM. Frequency and Severity of Acute Toxicity of Pelvic Radiotherapy for Gynecological Cancer. J Coll Physicians Surg Pak. 2015 Nov;25(11):802-6.

  PMID: 26577965 BACKGROUND

• Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.

  PMID: 30667494 BACKGROUND

• Lam E, Yee C, Wong G, Popovic M, Drost L, Pon K, Vesprini D, Lam H, Aljabri S, Soliman H, DeAngelis C, Chow E. A systematic review and meta-analysis of clinician-reported versus patient-reported outcomes of radiation dermatitis. Breast. 2020 Apr;50:125-134. doi: 10.1016/j.breast.2019.09.009. Epub 2019 Sep 19.

  PMID: 31563429 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share