Please select the eligibility criteria that correspond to the clinical trial below.
Title: International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17
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


Options:
A: Inclusion Criteria

* 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
* No obvious cognitive impairments, as judged by the study coordinator upon inclusion
* Age 18 years or above
* Provision of written informed consent
* No participation in another trial or study possibly interfering with the present study

Exclusion Criteria:

* 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
B: Inclusion Criteria:

* women 18-75 years
* operated for breast cancer stage I-III at either Herlev hospital (F-118) or Ringsted sygehus (Mammakirurgisk Klinik) after september 2006
* speak and read danish

Exclusion Criteria:

* other cancers
* diseases or disabilities hindering MBSR-participation
* active treatment for psychiatric disease including alcohol abuse
C: Inclusion Criteria:

* 21 years or older
* Diagnosed with Stage 0, I, II, or III breast cancer
* Undergone lumpectomy and/or mastectomy and are at 2 weeks from end of treatment with adjuvant radiation and/or chemotherapy or are a maximum of 2 years out from completion of such treatment
* Ability to read and speak English at the 8th grade level or above to respond to survey questions

Exclusion Criteria:

* Advanced stage (IV) cancer
* Current psychiatric diagnosis
* Recurrent treatment for prior breast cancer
D: Inclusion Criteria:

* Being aged between 35 and 75 years,
* Being able to read and write using the Spanish language,
* History of treated Breast Cancer within the past 15 years,
* Free from oncological illness
* Not receiving any kind of chemotherapy and / or radiotherapy treatment during study.

Eligible participants were contacted by their personal psychooncologist either by a telephone call or at psychooncology appointment periodical visit to invite them to an explanatory meeting of the study.

Exclusion Criteria:

* Active severe mental disorders (schizophrenia, bipolar disorder, eating disorders, and major depression),
* Substance use disorders, cognitive impairment,
* Impaired medical condition.

Past and current psychiatric and medical history was determined by clinician assessment with the Mini International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997) Spanish version (Lobo et al., 1999).

Answer: A