To asses the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on well-being of patients on LHRH analogs in the treatment of prostate cancer and their partners.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Adjustment disorders (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sufficiënt interest in participation, made clear by:
- Recruitment of 50 couples in 1,5 year in the participating centers
- 20% of couples that were informed personally about the study consent to
participate
- 80% of participants group 1 attends at least 70% of the sessions
Some indication for improvement in well-being
- - Group 1 should improve more than group 2 at at least one of the
- outcome measures (HADS, EORTC QLQ-C30 or
- Maudsley Marital Questionnaire) - after the intervention period of 16 weeks
(T1)
- - Group 1 should not worsen more than group 2 on any of the outcome
measures - after the intervention period of 16 weeks
(T1)
Secondary outcome
Depression and anxiety (patient) will be assessed with the Hospital Anxiety and
Depression Scale (HADS) at baseline (T0), after the intervention period of 16
weeks (T2) and at 1 year (T2).
EORTC QLQ-C30 (patient + partner) and QLQ-PR25 (patient) scores will be
assessed at baseline (T0), after the intervention period of 16 weeks (T1) and
at 1 year (T2). The HADS (partner) will be assessed at baseline (T0), after the
intervention period of 16 weeks (T1) and at 1 year (T2) and the relationship
satisfaction (patient and partner) with the Maudsley Marital Questionnaire at
baseline (T0), after the intervention period of 16 weeks (T1) and at 1 year
(T2). Distress meter (Lastmeter) will be assessed at baseline T0 (patient).
- difference between change in HADS scores at baseline (T0) and after the
intervention period of 16 weeks (T1) between patients in group 1 and group 2.
- difference between change in QLQ-C30 scores at baseline (T0), after the
intervention period of 16 weeks (T1) and at 1 year (T2) between patients and
partners in group 1 and group 2
- difference between change in QLQ-PR25 scores at baseline (T0), after the
intervention period of 16 weeks (T1) and at 1 year (T2) between patients in
group 1 and group 2.
- difference in relationship satisfaction (Maudsley Marital Questionnaire)
between baseline (T0), after the intervention period of 16 weeks (T1) and at 1
year (T2) in patients and partners group 1 and 2.
- difference between level of depression and anxiety (HADS) in patients and
partners between baseline (T0) and at 1 year (T2) in group 1 and group 2
- The distress meter (lastmeter) will be used to describe the patient population
The following clinical and demographic data will be collected during (regular)
urologist visits are used to describe the patient population:
- Date of birth
- Education level
- Date of diagnosis
- Use of LHRH-analogue
- Anti-androgen (type + posology)
- TNM classification if available. In case of M1, location and extent of
lesions if any
- Gleason score (primary + secondary)
- Testosterone (in case pre-hormonal treatment testosterone is available, this
will be documented)
- PSA
- Medical history
- Co-medication (e.g. analgesics)
- Co-morbidity (Charlson Index, decrease renal functioning)
- Co-intervention
- VAS (pain)
After the sessions the therapy will be evaluated by in-depth interviews with
volunteers (group 1): couples or individuals in order to gain qualitative
feedback on the therapy provided.
All participants will be asked after the intervention period of 16 weeks (T1)
and at 1 year (T2) which, if any, additional therapy they have received for
descriptive purposes.
Background summary
There is an increasing awareness for the patients need for psycho-oncological
care in the Netherlands (introduction of distress meter in hospitals, providing
additional care by oncology nurses). The Helen Dowling Institute aimes at
providing psycho-oncological care by individual therapy, group counselling and
on-lin therapy (fatigue - national coverage) to patients (Utrecht area) and
their partners and family. In the past they have evaluated the quality of life
of prostate cancer patients, but currently there is no (group) therapy
specifically aimed at prostate cancer patients. As prostate cancer patients are
still a diverse group of patients and because the side effects of hormonal
therapy can have an influence on the life or patients and their partners, it
was chosen to develop a group therapy (by means of information sessions)
specifically aimed at this group of patients.
Next to impotence (which also frequently occurs in patients who are treated
with curative intent), these patients also suffer from amongst others loss of
libido, fatigue, change of body (more fat, less muscle mass), emotional
instability as a consequence of the decrease of testosteron (below castration
level). The purpose of the therapy is to learn how to deal with these aspects
of the treatment and to improve the well-being and the partner relationship.
Before setting up a large trial on the effect of the above mentioned therapy we
first want to know, by means of this study, if the conduct of such a large
trial is feasible.
Study objective
To asses the feasibility of conducting a larger trial to evaluate the effect of
a psychological intervention on well-being of patients on LHRH analogs in the
treatment of prostate cancer and their partners.
Study design
Multi-centre, randomized, clinical trial (RCT).
Intervention
A psycho-oncological intervention given in groups.
Group 1 (n=25 patients + partners) will receive the psycho-oncological
intervention in 8 sessions (1 intake consult (2 hours), 6 group therapy
sessions (by means of information sessions) lasting 2 hours (first 3 with an
interval of 1 week, the last 3 with an interval of 2 weeks) followed by one
group session 1 month later.
Group 2: (n= 2l intervention group 1) and at 1 year. The primary endpoint
will be the difference between change in HADS scores at baseline (T0) and after
the intervention period of 16 weeks (T1)) between patients in group 1 and
group 2.5 patients + partners) will receive usual care
Study burden and risks
no risks are being expected.
Taurusavenue 33b
Hoofddorp 2132 LS
NL
Taurusavenue 33b
Hoofddorp 2132 LS
NL
Listed location countries
Age
Inclusion criteria
- Patient and partner must give written (personally signed and dated) informed consent before completing any study-related procedure.
- Histologically confirmed diagnosis of prostate cancer on biopsy.
- Locally advanced or metastasised prostate cancer in need of hormonal treatment.
- On LHRH analogue treatment for a minimum of 5 months (at inclusion).
- Patients and their partner are able to fill out questionnaires, attend group sessions and give consent
- Having a female partner
Exclusion criteria
-Serious psychiatric difficulties
-Life expectancy < 12 months
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 |
|---|---|
| ClinicalTrials.gov | NCT01562522 |
| CCMO | NL38379.100.11 |