Evaluation of the effect of psycho-oncological intervention on well-being of patients with advanced prostate cancer on LHRH analogs and their partners. A randomized controlled pilot study.

Evaluation of the effect of psycho-oncological intervention on well-being of patients with advanced prostate cancer on LHRH analogs and their partners. A randomized controlled pilot study. - EXPEDIENT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39520

Enrollment

Registered

2012-02-07

Start date

2012-03-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coping / adaptation

Interventions

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 ses

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: -Serious psychiatric difficulties -Life expectancy

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Secondary

Measure	Time frame
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,	—

Measure

Time frame

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,

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)