An international field study for the reliability and validity of the EORTC Sexual Health Questionnaire (EORTC SHQ-C22) for assessing sexual health in cancer patients

The diagnosis and treatment of cancer causes significant physical, psychological, and social effects that interfere with a person’s sexuality. Sexuality is complex and broadly defined concept comprising: the sexual response cycle, body image, ones’ sexual role and sexual relationships. Several EORTC cancer site specific modules include a limited number of sexual functioning items that do not adequately cover the whole range of sexual health which are most important for cancer patients.

The EORTC Sexual Health Questionnaire – Cancer (EORTC SHQ-C22) was developed as a standalone measure following the standard phase 1-3 procedures. Five multi-item scales (Sexual response, side-effects influencing sexual activity, relationship, global sexual health, male sexual health issues, and female sex health issues) and one single scale (communication with health care professionals concerning sexual health) are proposed.

The aim of this international field study is to test the scale structure, reliability, responsiveness to change and validity of the EORTC SHQ-C22 in patients with different cancer diagnoses, at different stages of disease, and with different treatment modalities. We will investigate the cross-cultural applicability and acceptability, scale structure, reliability, including test-retest and internal consistency, construct, divergent and convergent validity (know-group comparisons), and sensitivity to change. Study participants will be enrolled in four groups:

Group A: Patients undergoing surgery alone (N=100)

Group B: Patients who receive chemotherapy and/or radiotherapy and/or endocrine therapies as

first line treatment with curative intention (N=100)

Group C: Patients who receive palliative treatment (any treatment) (N=100)

Group D: Patients with no evidence of disease (NED) who have completed treatment for at least

6 months up to 5 years (test-retest) (N=100).

A sample of 400 patients from twelve countries will be recruited. Participants will be invited to complete the QLQ-C30 and the SHQ-C22, followed by the Debriefing Questionnaire. Data of all patients (Group A-D) will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the SHQ-C22 for a second time a week later for the test-retest analysis (Group D). Patients who change the disease or treatment status after the first assessment will be invited to complete a second set of questionnaires for the response to change analysis (Group A, B). Sociodemographic and clinical data will be recorded using standardized case report forms (CRF). EORTC CHES will be used for data collection where possible.

Standard psychometric analyses will be employed to evaluate the hypothesized scale structure of the SHQ-C22, to confirm the psychometric properties of its scale and to assess cross-cultural measurement invariance. Subgroup analysis will be conducted subgroup to identify site specific QoL/Sexual health profiles.