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…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is to confirm the hypothesized scale
structure of the EORTC SHQ-C22.
Secondary outcome
Scale Structure, Reliability, Convergent validity, Known-group comparisons,
Responsiveness to change analysis
Background summary
The EORTC Quality of Life Group established standardized guidelines for
developing questionnaires20: (1) generation of QoL issues aiming to identify
issues relating to sexual health in patients diagnosed with different cancer
sites, (2) operationalisation to derive modifications to the preliminary module
using a structured interview method, and (3) pre-test the preliminary
questionnaire module in order to identify and solve potential problems in the
administration and to determine the need for additional questions or the
elimination of questions. The process of translation follows a rigorous
forward-backward procedure according to the EORTC translation guidelines.
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 EORTC SHQ-C22 has been developed as a stand-alone measure to assess sexual
health of cancer patients. The questionnaire can be used in all treatment
options (surgery, chemotherapy, radiotherapy, targeted therapy) and all
settings of health care (acute care, palliative care, rehabilitation). Thus, it
is applicable for all cancer diagnosis as well as all phases and stages of
cancer. The SHQ-C22 is designed in a way that it can be used as a single
measure or in conjunction with the EORTC QLQ-C30
Study objective
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 design
For patients in Group A and B a second assessment will be performed when
patients return to the hospital for a follow-up visit (Group A) or during
treatment (Group B). For test-retest patients in Group D will be asked to
complete the EORTC QLQ-C30, the SHQ-C22 for a second time seven days after the
first assessment. The questionnaires will either be sent in the post or
participants may take them home after the first appointment. A prepaid envelope
will be supplied and patients will be asked to return the completed
questionnaires to their local investigator. If this second assessment is not
mailed back within 14 days after the follow-up interview, one reminder will be
made by telephone call.
Study burden and risks
Completing a questionnaire twice (about 15 mins each time) and a short
debriefing questionnaire, in which the questions involve intimate, private,
sexual aspects of the participant's personal life.
Auenbruggerplatz 2
Graz A-8036
AT
Auenbruggerplatz 2
Graz A-8036
AT
Listed location countries
Age
Inclusion criteria
The study sample will be composed of a consecutive series of cancer patients who meet the study eligibility criteria in each participating centre. Study participants will be enrolled in four groups: Group A: Patients undergoing surgery alone Group B: Patients who receive chemotherapy and/or radiotherapy and/or endocrine therapies as first line treatment with curative intention Group C: Patients who receive palliative treatment (any treatment) Group D: Patients with no evidence of disease who have completed treatment for at least 6 months up to 5 years (test-retest) The SHQ-C22 will be used in patients from across all cancer sites and stages. Sampling will be on the basis of gender, age, primary cancer diagnosis and treatment. Inclusion criteria: a) Histological confirmed diagnosis of cancer (primary, recurrent or metastatic disease) b) Any tumour site and stage c) Mentally fit to complete the questionnaires d) Able to understand the language of the questionnaires e) 18 years of age or above f) Patient is willing to give informed written consent
Exclusion criteria
Patients participating in other QoL studies that might interfere with this study b) Patients who are unable to self-complete the questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57543.058.16 |