The primary objective of the present study is to obtain insight into the long-term effects of EC and new treatment strategies on HRQL in a population-based setting. Therefore, we will assess HRQL among 2 to 9 year survivors of stage I or II EC…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The association between cancer treatment and quality of life (generic and
disease specific)
Secondary outcome
Patientcharacteristics (personality) in relation to quality of life and
morbidity (fatigue, anxiety, depression)
Background summary
The prevalence of cancer is rising. The increasing incidence of cancer, ageing
of the population and more effective treatment strategies all contribute to
this rapid increase. Based on data from the Netherlands Cancer Registry, the
Dutch Cancer Society estimated that in 2005, about 1700 women were diagnosed
with EC in the Netherlands, with an estimated prevalence of over 17,000,
expected to increase to 25,000 in the year 2015.
Results of our previous study among endometrial cancer survivors showed that
adjuvant radiotherapy was independently and negatively associated with
vitality, physical and social well-being scales. Nevertheless, that study
consisted of women diagnosed in the period 1994-1998, whereas afterwards
treatment has changed in several hospitals in the ECR area. Rather than
treating intermediate and high risk patients with radiotherapy, several
gynaecologists since then started to perform pelvic lymphadenectomy, thereby
administering radiotherapy only to patients with lymph-node metastases. As a
result fewer patients will experience the negative sequelae associated with
adjuvant EBRT. However, lymphadenectomy can result in lymfedema which are
expected to have a diminishing effect on HRQL.
Study objective
The primary objective of the present study is to obtain insight into the
long-term effects of EC and new treatment strategies on HRQL in a
population-based setting. Therefore, we will assess HRQL among 2 to 9 year
survivors of stage I or II EC treated with surgery alone (with or without
lymfadenectomy) or surgery and adjuvant EBRT, and compare them with an
age-matched norm population. A secondary objective is to investigate the
association between co-morbidity, life-style factors (such as smoking, physical
activity, personality) and HRQL, rather than treating them as confounding
variables only.
Study design
Cross-sectional observational study of 1200 EC survivors who are approached by
their (formerly) treating specialists: Gynaecologists will send their (former)
patients a letter to inform them about the study and a copy of the
questionnaire. The letter will explain that by returning the completed
questionnaire, the patient agrees to participate and consents with linkage of
the outcome of the questionnaire with their disease history. If the
questionnaire is not returned within 6 weeks, a reminder letter will be send.
Study burden and risks
Participation does not form a risk for the patient, psychological burden can be
avoided by the patient by not completing the questionnaire.
Postbus 231
5600 AE Eindhoven
Nederland
Postbus 231
5600 AE Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
Endometrial Cancer survivor, diagnosed with EC stage I or II between 1999 and 2006, not older than 85 at time of the survey
Exclusion criteria
Participants older than 85 years at time of the survey will be excluded, as previous studies pointed out that they would have difficulty in completing a self-report questionnaire without assistance because of very old age.
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 | NL19760.015.07 |