Actively Recruiting

Age: 18Years +
All Genders
ID06662929

Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study

Led by King Saud University · Updated on 2024-10-29

125

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating Arabic patient-reported outcome measure (PROM) tools for people with head and neck cancer undergoing radiotherapy. These tools have not been cross-culturally validated in Arabic-speaking patients, which limits their clinical use. The study aims to validate these PROM instruments and explore the prevalence and severity of patient concerns related to their demographics and clinical characteristics. This observational study involves Arabic-speaking adults aged 18 and older who are planned to receive, currently receiving, or have already received radiotherapy for head and neck cancer. Participants will complete six different survey tools before, during, and after radiotherapy to assess symptoms such as dry mouth, oral mucositis, fatigue, and other concerns. Participants will be asked to complete questionnaires at multiple time points over 24 months. Researchers will collect and analyze patient-reported data using tools like the Summated Xerostomia Inventory, Patient-Reported Oral Mucositis Symptom scale, and others. The study will help clinicians better understand patient experiences and outcomes during and after radiotherapy.

CONDITIONS

Brief Title

Arabic PRO Measures for Head and Neck Cancer Radiotherapy.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 or above
  • Planned for, currently receiving, or have received radiotherapy for head and neck cancer
  • Able to read, understand, and sign informed consent
  • Receiving care at King Saud University Medical City
Not Eligible

You will not qualify if you...

  • Individuals under 18 years old
  • Presence of debilitating disease such as heart failure
  • Unable to read, understand, or sign informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 24 months

Participants who undergo radiotherapy for head and neck cancer are observed and complete questionnaires about their symptoms and concerns.

Periodic questionnaire assessments during and after radiotherapy

Trial Site Locations

Total: 1 location

1

King Saud University Medical City

Riyadh, Saudi Arabia

Actively Recruiting

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Research Team

A

Abdullah M Alsoghier, PhD

S

Saif A Aljabab, DABR

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

The Head and Neck Cancer Patient Concern Inventory© : Patient Concerns' Prevalence, Dental Concerns' Impact, and Relationships of Concerns with Quality of Life Measures.

Maria L Aguilar, Pamela Sandow, John W Werning...

https://pubmed.ncbi.nlm.nih.gov/28220985

Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI).

Gianluca Catania, Carol Bell, Simona Ottonelli...

https://pubmed.ncbi.nlm.nih.gov/22790224

Biomarkers of fatigue related to adjuvant chemotherapy for breast cancer: evaluation of plasma and lymphocyte expression.

Felipe M Cruz, Bruna A Munhoz, Beatriz Ca Alves...

https://pubmed.ncbi.nlm.nih.gov/25852820

Health-related quality of life at 3 months following head and neck cancer treatment is a key predictor of longer-term outcome and of benefit from using the patient concerns inventory.

Anastasios Kanatas, Derek Lowe, Simon N Rogers

https://pubmed.ncbi.nlm.nih.gov/35178880