This study will contribute to improving quality of care for cancer survivors, since sexual problems seem to be profound but not always discussed with patients. Patients are now often insufficiently informed and do not know how to interpret their…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters: Subjective sexual functioning, objective sexual
functioning
Outcome of the study: Quality of (sexual) life, health status
Secondary outcome
Secundary study parameters: Personality, mood states (anxiety/depression)
Outcome of the study: Quality of (sexual) life, health status, healthcare needs
Background summary
The results of this prospective study will give insight in 1) the incidence of
sexual problems and the extent patients with colorectal cancer are bothered by
these problems across time, 2) the effect of different treatment options on
sexual functioning, 3) the relation between sexual problems and quality of
life, and 4) the determinants of sexual problems and quality of sexual life
adopting the biopsychosocial approach of patients with colorectal cancer who
have been treated with surgery, radiation and/or chemotherapy, and more
specifically to the role of personality and partner factors and sexual
functioning/quality of sexual life, 5) the healthcare needs of patients and
their partners with regard to sexuality and intimacy.
Study objective
This study will contribute to improving quality of care for cancer survivors,
since sexual problems seem to be profound but not always discussed with
patients. Patients are now often insufficiently informed and do not know how to
interpret their early and long-term physical or psychosocial problems.
Characterizing the sexual problems of colorectal cancer patients and their
partners and identifying factors that may alleviate the adverse effects of
sexual dysfunction. Knowledge of potential future problems in sexual function
should be incorporated into preoperative counselling and guiding treatment
decisions. In this way, patients are allowed to make better informed decisions
about the management of colorectal cancer. Sexual dysfunction may significantly
impact patient*s subsequent quality of life. Knowledge about sexual problems is
essential in order to educate both health professionals and patients about
potential problems after medical treatment. However, as sexuality can be seen
as a multidimensional construct, the development of psychosocial interventions
will also benefit.
Study design
Patients who are diagnosed with colorectal cancer at one of the participating
hospitals during the period May 2010 and May 2014, and their partners will be
asked to participate. Participants will be asked to complete questionnaires on
sexual functioning, quality of life, fatigue, depressive symptoms, personality
factors, and demographic factors. Questionnaires will be completed before
surgical treatment or preoperative radiotherapy and at 6 weeks, 3, 6, and 12
months after diagnosis. Questionnaires on demographic and personality factors
will only be filled in at baseline.
500 patients will be included within 2 years
A subgroup of patients and their partners will be asked to participate in
separate focus group interviews. The participants will be purposively selected
from their participation in the larger prospective study. In addition, we want
to recruit couples of whom the patient has been diagnosed with colorectal
cancer between 2008 and 2010, to ensure a wide variety of experiences to be
represented. The focus group meetings are designed to assess the healthcare
needs of patients and their partners with regard to sexuality and intimacy and
how these healthcare needs can be best addressed. Furthermore, in order to
investigate possible discrepancies between couples coping with colorectal
cancer and their healthcare professionals we additionally want to conduct a
focus group meeting with healthcare professionals in order to explore how they
perceive the healthcare needs of couples coping with colorectal cancer and how
these healthcare needs can be best addressed. There will be two focus groups
consisting of patients (n=10 per group), two focus groups in which the partners
will participate (n=10 per group), and one focus group in which the healthcare
professionals will be interviewed (n=10). Each focus group will take 90
minutes.
Study burden and risks
Burden: 4 hours / 5.5 hours (depending on participation in the focusgroup
meeting)
Risks: not applicable
Postbus 90153
5000 LE Tilburg
NL
Postbus 90153
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with colorectal cancer and their partners.
Exclusion criteria
Recurrence of disease at baseline; poor expression of the dutch language; dementie; a history of psychiatric illness.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL32121.008.10 |
OMON | NL-OMON27180 |