NCT03093649

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

March 16, 2017

Last Update Submit

March 22, 2017

Conditions

Nasopharyngeal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Score of physical functioning in quality of life

    Score of physical functioning in quality of life

    within 1 week of study completion

Secondary Outcomes (7)

  • 3-year overall survival

    3 year after diagnosis

  • 3-year progression-free survival

    3 year after diagnosis

  • 3-year local-regional free survival

    3 year after diagnosis

  • 3-year metastatic-free survival

    3 year after diagnosis

  • completion rate

    within 1 week of study completion

  • +2 more secondary outcomes

Study Arms (2)

patient reported group

EXPERIMENTAL

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.

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

non-reported group

ACTIVE COMPARATOR

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)

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

Interventions

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

The intervention was administrated through APP

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

patients receive normal care and visit

non-reported group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 28, 2017

Study Start

July 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

CN(1)