Observational multicenter trialThe following research questions (Q) will be addressed in patients (and partners) (Q1) whether sexual problems as reported by female cancer survivors are personally distressing and if so, ( Q2) what are possible…
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
sexual complaints, sexual distress and needs
Secondary outcome
treatment, somatic and psychological variables
Background summary
Observational multicenter trial
Rationale: About half of the women treated for cervical cancer do report
long-term sexual complaints, which may be personal distressing in about 25% of
these women. Sexual rehabilitation for female cancer survivors lags far behind
that provided for men. There is an urgent need to develop suitable
interventions for sexual complaints in women. In our clinical experience,
however few women with sexual complaints after cancer treatment seek treatment
for their complaints. Reasons for not seeking help for sexual complaints
reported in the literature are (1) not experiencing sexual complaints as
distressing and (2) barriers in clinical practice to discuss sexual issues.
Therefore, we first want to conduct a needs assessment study in patients,
before we decide to develop and evaluate a sexual rehabilitation program for
female cancer survivors.
Qualitative study
Purpose: The main purpose of this study is to deepen and broaden the insights
that are gained from the observational multicenter trial study that is
currently being conducted.
Study objective
Observational multicenter trial
The following research questions (Q) will be addressed in patients (and
partners) (Q1) whether sexual problems as reported by female cancer survivors
are personally distressing and if so, ( Q2) what are possible barriers in
clinical practice to seek treatment for these complaints , and (Q3) whether
there is a need for (specific) treatment interventions. By including both
patients and their partners in the current study, we hope to identify
facilitating and limiting factors relevant for the development and evaluation
of a sexual rehabilitation program.
Qualitative study
The aims of this study are (Q1) to obtain insight in the development and course
of sexual dysfunctions and distress since the cancer diagnosis and treatment;
(Q2) to assess CC survivors* attitudes towards sexual health care and
information provision; (Q3) to identify CC survivors* experiences and/or needs
in terms of information and health care provision; (Q4) to address Health
Belief Model variables (and aspects mentioned by the participants) with respect
to cervical cancer survivors* help seeking behavior; and (Q5) to gain insight
into the partners* perspective with respect to the impact of SD and sexual
distress on the relation, the impact of having a care taking role on the sexual
relationship, and his/her sexual health care and information needs.
Study design
Observational multicenter trial
A survey (sexual complaints, personal distress; help-seeking behavior;
treatment suggestions) in a multicenter observational study.
Qualitative study
Semi-structured interviews will be conducted with women with a history of
cervical cancer who perceive sexual distress, and their partners.
Study burden and risks
Observational multicenter trial
Participants will complete questionaires about personal themes, which may be of
some discomfort for some of the participants. The total duration to complete
the questionnaires will be about 60 min. There will be no benefits for the
participants.
Qualitative study
Participants will be interviewed about personal themes, which may be of some
discomfort for some of the participants, while other participants might
experience discussing this topic as relieving . The interview will last 60 tot
120 minutes.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients will be recruited by reviewing medical files, collected prospectively in databases, of women who have undergone a treatment for early stage cervical cancer in the period 2000-2009.
Exclusion criteria
signs or recurrent metastatic cervical cancer, no follow-up due to living abroad; insufficient knowledge of the Dutch language.
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 | NL35147.058.10 |