NCT01562522

Brief Summary

The purpose of the protocol, is to assess the feasibility of conducting a larger trial to evaluate the effect of a psychological intervention on the well-being of patients on luteinizing hormone-releasing hormone (LHRH) analogs in the treatment of prostate cancer and their partners.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

March 21, 2012

Last Update Submit

November 6, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Sufficient interest in participation

    Determined by achievement of all of the following: * Number of participants (couples) recruited in 18 months in the participating centres. Achieved by recruitment of 50 couples. * Number of participants (couples) informed personally about the study consent to participate. To be achieved by 20% of couples. * Number of participants in group 1 that attend at least 70% of the sessions. To be achieved by 80% of participants.

    Up to the end of 16 weeks of the intervention period

  • Preliminary improvement in well-being

    Improved - Group 1 improve more than group 2 on at least one of the outcome measures (includes HADS, EORTC QLQ-C30 or Maudsley Marital Questionnaire). Worsened - Group 1 should not worsen more than group 2 on any of the outcome measures.

    After the intervention period of 16 weeks

Secondary Outcomes (5)

  • Change in quality of life questionnaire QLQ-C30 scores

    Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)

  • Change in quality of life questionnaire QLQ-PR25 scores

    Baseline(T0), after the intervention period of 16 weeks (T1) and 1 year (T2)

  • Difference in relationship satisfaction (Maudsley Marital Questionnaire)

    Baseline (T0), after the intervention period of 16 weeks (T1) and 1 year (T2)

  • Difference between level of depression and anxiety (HADS)

    Baseline (T0) and 1 year (T2)

  • Change in Hospital Anxiety and Depression Scale (HADS) scores

    Baseline (T0), after the intervention period of 16 weeks (T1)

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: Psychological counseling

Control group

NO INTERVENTION

Interventions

Psychological counselingOTHER

Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.

Intervention group

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of prostate cancer on biopsy
  • Locally advanced or metastasised prostate cancer in need of hormonal treatment.
  • Having a female partner
  • Patients and their partner are able to fill out questionnaires, attend group sessions and give consent

You may not qualify if:

  • Serious psychiatric difficulties
  • Life expectancy \< 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

Zuwe Hofpoort Ziekenhuis Woerden, Netherlands

Woerden, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Medical Director Oncology

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 26, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 7, 2019

Record last verified: 2019-11

Locations

NL(3)