Phase 1-3 development of a questionnaire for assessing sexual health in cancer patients:
A cross cultural project of the EORTC Quality of Life Group

Cancer and cancer therapies are frequently associated with sexual dysfunction.
Across sites, estimates of sexual dysfunction after various cancer treatments
have ranged from 40% to nearly 100%. Research suggests that about 50% of women
who have had breast or gynecologic cancer experience long-term sexual
dysfunction including vaginal changes or urological symptoms; and for men with
prostate cancer, erectile dysfunction has been the primary form of sexual
dysfunction investigated. Meta-analysis showed that nearly 70% of men who have
been treated for prostate cancer experience long-term sexual dysfunction. The
most common sexual problems for people who have cancer are loss of desire for
sexual activity in both men and women, problems achieving and maintaining an
erection in men, and pain with intercourse in women.

Unlike many other physiological side effects of cancer treatment, sexual
problems do not tend to resolve within the first year or two of disease-free
survival rather, they may remain constant and fairly severe or even continue to
increase. Long-term effects of different treatment on sexual functioning have
been studied in cervical cancer survivors. Existing research has focused on
women who have breast or gynecologic cancer and men who have prostate cancer.
Less is known about how other types of cancers affect sexuality. Although it is
unclear how much sexual problems influence a survivor*s rating of overall
health-related quality of life, these problems are clearly bothersome to many
patients and interfere with a return to normal post-treatment life.

The aim of this project is to develop a comprehensive EORTC questionnaire for
assessing sexual health for male and female patients with cancer. Given the
lack of a sexual health related measure that can be used in clinical trials and
in clinical praxis the decision has been made to develop a *stand-alone* sexual
health questionnaire according to the EORTC QLG guideline (Blazeby et al.
2002). Since this sexual health measure should be applicable to all cancer
patients, and the literature review showed that not all cancer sites were
well-represented, it is necessary to include a broad range of cancer patients
with different cancer sites.

In each country a list of issues will be administered to a sample of male and
female cancer patients with different cancer sites. Both newly diagnosed
patients under treatment and in post-treatment follow-up will be interviewed.
When selecting the patients for interviews, care will be taken to ensure a
balanced patients group covering the major cancer sites as well as rarer
disease sites

The development of the EORTC Sexual Health questionnaire is done according to
standard procedures for EORTC QoL questionnaire development -
phase 1: Literature review: a comprehensive review of the literature has
already been conducted resulting in a list of 126 issues.
By use of patient and HCP interviews the list of issues is reduced according to
priority ratings. On the basis of both - patients and HCPs response - the list
of sexual health issues will be adapted. Decisions on which issues to keep or
delete will be made using the EORTC module development guidelines and decision
rules (Blazeby et al. 2002).
phase 2: the list of issues will be operationalised into items. The QLG Item
Bank, existing EORTC modules, and other questionnaires reviewed for items that
deal with the selected issues will be searched. Remaining issues will be
converted into novel items in a style and format compatible with the EORTC QLQ
assessment system, and any necessary translations will be carried out following
EORTC QLG Translation Guidelines (Cull et al 2002).
Phase 3: In phase 3 the sexuality items will be pre-tested to identify and
solve potential problems (e.g. terminology, phrasing) and to determine the need
for additional questions or the elimination of items. Patient interviews will
be conducted to assess relevance and priority of each item in the provisional
questionnaire (Appendix 3). A broad range of patients with different cancer
sites and treatment modalities will be approached. Patients with different
cancer sites under first line treatment or post-treatment follow up will be
included. Following the EORTC QLG Guidelines for questionnaire development
patients will be asked to rate the relevance and priority of each item on a
four-point scale. They will be asked to suggest any relevant items which were
not included in the list or to delete items that are irrelevant. The items will
be used to check content validity. The feedback of patients will help to refine
the conceptual mode. This approach will provide assurance that the QLG
objectives of Phases 1 and 2 have been met.
We will aim for 15 patients diagnosed with various cancer sites in 11
countries. This will result in a total sample of 165 interviews (15 patients x
11 countries = 165). Care will be taken to ensure a balanced patients selection
covering the major cancer sites as well as rarer disease sites. A debriefing
questionnaire to assess the wording of items and check for omissions or
redundancy will be completed. Clinical and socio-demographic data will be
collected from each patient.

Burden: competion (10 mins) of a questionnaire involving sexuality issues, and
a short debriefing interview.