The primary objective of the present study is to obtain insight into the long-term effects of new therapies on the HRQL of colorectal cancer survivors in a population-based setting. Therefore, we will measure the HRQL of newly diagnosed and up to 10…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The association between cancer treatment on quality of life (generic and
disease-specific) and health-care utilization.
Secondary outcome
Patient characteristics (personality, illness perceptions) and satisfaction
with information in relation to HRQL and morbidity (fatigue, anxiety and
depression)
Background summary
New and more effective therapies have contributed to the growing cohort of
colon and rectal cancer survivors. nevertheless these patients remain at risk
for adverse long-term effects of cancer and its initial treatment, possibly
related to increased health-care use. A growing number of studies have
documented the impact of cancer diagnosis and treatment on HRQL in short-term
survivors, but less attention has been focused on HRQL in long-term colon and
rectal cancer survivors. There are no longitudinal studies evaluating the HRQL
of CRC survivors who had recieved the newer therapies.
Study objective
The primary objective of the present study is to obtain insight into the
long-term effects of new therapies on the HRQL of colorectal cancer survivors
in a population-based setting. Therefore, we will measure the HRQL of newly
diagnosed and up to 10 years survivors of colorectal cancer, with follow-up
every 2 years for the next 6 years, and compare them with an age-matched norm
population. Secondary objectives of the study are to investigate the
association between comorbidity, lifestyle factors (smoking, physcial
activity), psychological factors (personality, illness perceptions) and HRQL,
rather than treating them as confounding variables only.
Study design
Longitudinal population-based study of 2000 colorectal cancer survivors who are
approached by their (former) treating specialists. Gastroenterologists will
send their (former) patients a letter to inform them of the study, together
with a copy of the questionnaire. The letter explains that by returning the
completed questionnaire, the patient has consented to participation and to the
linkage of the outcome of the questionnaire with his/her disease history. If
the questionnaire is not returned within 8 weeks, a reminder will be sent.
Study burden and risks
Participation does not pose a risk to the patient as psychological burden can
be avoided by the patient by not completing the questionnaire.
Postbus 231
5600 AE Eindhoven
NL
Postbus 231
5600 AE Eindhoven
NL
Listed location countries
Age
Inclusion criteria
All currently alive colon or rectal cancer survivors diagnosed between 1998 and 2008 (at least 6 months from start of study), and not older than 85 years at time of survey.
Exclusion criteria
Participants 85 years and older at the time of study will be excluded as previous studies showed that they will require extensive assistance in completing the self-report questionnaire
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 | NL23463.015.08 |