Clinical trial NCT05407116: Prospective Evaluation of Gastrointestinal and Genitourinary Side Effects of Pelvic Radiotherapy
Official title: Prospective Evaluation of Gastrointestinal and Genitourinary Side Effects of Pelvic Radiotherapy: Association Between Patient-Reported Outcomes and Clinician-Reported Outcomes With A View To Improving Quality of Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy Side Effects
Keywords: PROs
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: BACKGROUND: The classic endpoints in cancer clinical trials typically include tumour control rate, overall survival, or disease-free survival; however, it is becoming essential to consider the impact of cancer treatments on patients' quality of life (QoL) (1,2). Cancer researchers have used different methods to assess the effectiveness of therapeutic interventions according to their influences on health-related QoL (3,4). As with other cancer treatments, while radiotherapy (RT) can benefit cancer patients, its side effects can negatively impact QoL (5). Patients undergoing pelvic radiotherapy frequently develop acute gastrointestinal (GI) and genitourinary (GU) toxicities during treatment (6,7). If aware, the multidisciplinary team can manage ongoing problems patients are experiencing. This includes medical management, nutritional support and advice, and referral to other specialties (8). To date, most studies on toxicities from pelvic RT have used clinician-reported outcomes (CROs) for reporting intra-treatment assessments and guiding clinical practice and symptom management, but recent research shows that PROs better capture the quality of life issues that patients care about. In addition, consideration of patient-reported outcomes (PROs) leads to increased cancer treatment tolerance, reduced emergency room visits, earlier detection of recurrences, and improved survival (9,10). To our knowledge, there is no published prospective data assessing the association of CROs with PROs for GI/GU toxicities and QoL in patients undergoing radiation therapy to the pelvis. Therefore, there is a need to objectively examine how RT affects QoL in this patient group.

RATIONALE: Most patients who have radical pelvic RT as a treatment for cancer experience some degree of GI and GU toxicities (6,7). Anticipation, identification, and correct management of symptoms may significantly improve the QoL for those patients. This work aims to incorporate patient's voices during treatment and enhance the communication between patients and physicians, improve patients quality of life, and help early detection of adverse events All patients receiving standard or hypofractionated pelvic RT for the first time at the McGill University Health Centre Radiation Oncology clinic are eligible. Patients will complete, through a mobile application (Opal) and in real-time, validated electronic PRO questionnaires about acute GI/GU toxicities and QoL. These questionnaires will be administered at baseline, after each visit during RT, and at two subsequent time points, i.e., at two weeks and three-month follow-up visits. We will document data on any need for further assessment, prescriptions, emergency room visits, or admissions. The treating physician will fill in the traditional intra-treatment forms simultaneously.

ANALYSIS PLAN: Patient and treatment demographics will be summarized using proportions of categorical variables. We will perform a descriptive analysis for all GI/GU symptoms reported through patient and clinician questionnaires and assess the association between PROs and CROs over time using Somers' D statistic, Bowker's Symmetry test, and multilevel random effects regression models.

HYPOTHESIS: We hypothesize significant discordance between PROs and CROs when assessing GI/GU toxicities of pelvic RT and that CROs alone are insufficient in measuring GI toxicities as they fail to capture the impact on patients' quality of life. The study findings will assess the need for improved GI/GU symptom assessment and support the creation of a new algorithm that includes both patient and clinician input. In addition, physicians can influence the patients' quality of life by anticipating the problems and toxicities that need additional care, which they can appropriately expedite.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of collecting PROs and CROs for GI and GU toxicities prospectively and in real-time in a busy tertiary care cancer centre.
timeFrame: 18 weeks
measure: Assess the association between PRO and CROs over time
timeFrame: 18 weeks
Secondary outcomes:
measure: Exploring the influence of baseline characteristics on treatment-related GI and GU symptoms
timeFrame: 18 weeks
measure: Exploring the influence of baseline characteristics on health-related quality of life
timeFrame: 18 weeks
measure: Assess whether PRO/CRO scores are associated with subsequent patient healthcare outcomes (changes in medications, ER visits, hospital admissions)
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
References:
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