Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma

Sun Yat-sen University

Status: Unknown

Conditions: Nasopharyngeal Neoplasms

Treatments: Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire; Other: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire

Study type: Interventional

Funder types: Other

Identifiers

NCT03093649

2017-FXY-003-放疗科

Details and patient eligibility

About

Although patient-reported adverse events have been promoted as an essential element in clinical trials and daily managements, their efficacy remained unknown. The purpose of this trial was to determine the effect of the patient-reported adverse events during the treatment on the improvements on quality of life.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
• No evidence of distant metastasis (M0)
• Performance status: PS 0~2
• Receive standard treatment
• Able to read and understand the questionnaires
• Not exhibiting overt psychopathology
• Willing to give feedback to physicians and written informed consent was obtained

Exclusion criteria

• WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
• Treatment with palliative intent.
• Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
• Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
• Patient is pregnant or lactating
• Severe intercurrent disease

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

patient reported group

Experimental group

Description:

Patients reported adverse events using patient reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) through Application (APP) during the treatment. The summary report was transferred to their clinician immediately. Oncologists would be alarmed if patients reports exceeding the pre-defined threshold.

Treatment:

Other: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire

non-reported group

Active Comparator group

Description:

Patients in this group received normal care during the treatment without completing patient reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE)

Treatment:

Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire