International Validation of the QLQ-OH17 for Oral Health

NCT01724333 | Completed

• 2 other identifiers: 2012/1390REKEORTC-SG2012
• Study Type: observational
• Target: 585
• Locations: 10 countries
• Sites: 14

Brief Summary

Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues to improve symptom management has been requested. The present study will be conducted on behalf of and with support from the European Organisation for Research and Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step, in the development of an international, symptom specific questionnaire module, focusing on oral and dental problems in relation to cancer and its treatment. Phase I-III of this stepwise development process was conducted from 2008 to 2011, as an international collaboration and conducted according to the guidelines for module development set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field testing and validation study as described in this project description. The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item scales (pain/discomfort, xerostomia, eating and information) and three single items related to use of dentures and future worries. The aim of the present study is to conduct phase IV; an international field study to confirm the psychometric properties of the QLQ-OH17

Conditions

Quality of Life; Adverse Effects; Late Effects; Cancer; Xerostomia

Keywords

EORTC QLQ-C30; Oral health; Quality of life; Questionnaires; Patient reported; outcomes

Outcome Measures

Primary Outcomes (1)

• Oral morbidity

  The study aims to validate a questionnaire for assessment of oral morbidity, oral health , and quality of life in relation to cancer treatment. Specific outcomes are prevalence of patients with moderate to severe oral morbidity due to cancer treatment (mucositis,stomatitis, taste change, decayed /loose teeth, osteoradionecrosis, ulcers), to investigate if the severity varies with certain background variables , for example, diagnostic group, age, sex, stage of disease, type of treatment, and to investigate the discriminant validity, reliability and responsiveness of the specific items in patient subgroups

  Up to two years

Secondary Outcomes (1)

• Quality of life

  Up to two years

Study Arms (5)

Group 1- in active treatment

Questionnaires only

Group 2 - 2-6 months post-treatment

Questionnaires only

Group 3 - 6 mos-3yrs post-treatment

Questionnaires only

Group 4 - Palliative treatment

Questionnaires only

Group 5 - Referred to dentist/oral team

Questionnaires only

Eligibility Criteria

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

Study Population

An international, cross-cultural sample of cancer patients with different diagnoses in different phases of treatment

You may qualify if:

• Patients with a verified cancer diagnosis other than basal cell carcinoma, incl. H\&N cancer
• Sufficient language ability to understand and complete the questionnaires without assistance
• Age 18 years or above
• Provision of written informed consent
• No participation in another trial or study possibly interfering with the present study

You may not qualify if:

• Patients being diagnosed with basal cell carcinoma
• Patients who have been included in Phase I-III of the module development
• Patients who are in the terminal phase of cancer
• Patients who are unable to participate in the interviews do to obvious cognitive impairment, psychological disturbance or language problems

Sponsors & Collaborators

• Oslo University Hospital: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (14)

University of Metz

Metz, France

Location

University of Leipzig

Leipzig, Germany

Location

Johannes Gutenberg University Mainz

Mainz, Germany

Location

University of Athens

Athens, Greece

Location

Tel-Aviv University

Tel Aviv, Israel

Location

Istituto Nazionale Tumori "Fondazione G. Pascale"- IRCCS,

Naples, Italy

Location

Academic Centre for Dentistry Amsterdam

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

University of Oslo

Oslo, Norway

Location

J. Dietl Specialistic Hospital,

Krakow, Poland

Location

Jagiellonian University Medical College

Krakow, Poland

Location

Karolinska University Hospital

Stockholm, Sweden

Location

University of Leeds

Leeds, United Kingdom

Location

Related Publications (3)

• Hjermstad MJ, Bergenmar M, Bjordal K, Fisher SE, Hofmeister D, Montel S, Nicolatou-Galitis O, Pinto M, Raber-Durlacher J, Singer S, Tomaszewska IM, Tomaszewski KA, Verdonck-de Leeuw I, Yarom N, Winstanley JB, Herlofson BB; EORTC QoL Group. International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15. Support Care Cancer. 2016 Sep;24(9):3915-24. doi: 10.1007/s00520-016-3216-0. Epub 2016 Apr 25.

  PMID: 27113466 BACKGROUND

• Hjermstad MJ, Bergenmar M, Fisher SE, Montel S, Nicolatou-Galitis O, Raber-Durlacher J, Singer S, Verdonck-de Leeuw I, Weis J, Yarom N, Herlofson BB. The EORTC QLQ-OH17: a supplementary module to the EORTC QLQ-C30 for assessment of oral health and quality of life in cancer patients. Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Epub 2012 May 8.

  PMID: 22572480 RESULT

• Johns SA, Brown LF, Beck-Coon K, Talib TL, Monahan PO, Giesler RB, Tong Y, Wilhelm L, Carpenter JS, Von Ah D, Wagner CD, de Groot M, Schmidt K, Monceski D, Danh M, Alyea JM, Miller KD, Kroenke K. Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors. Support Care Cancer. 2016 Oct;24(10):4085-96. doi: 10.1007/s00520-016-3220-4. Epub 2016 May 17.

  PMID: 27189614 DERIVED

MeSH Terms

Conditions

Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Marianne J Hjermstad, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 9, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

NL (2); GR (1); IL (1); GB (1); PL (2); IT (1); FR (1); DE (2); NO (2); SE (1)