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Mental Wellbeing and Quality of Life in Prostate Cancer (MIND-P)

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ClinicalTrials.gov Identifier: NCT04647474
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborators:
King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Imperial College Healthcare NHS Trust
Medway NHS Foundation Trust
Lewisham and Greenwich NHS Trust
Surrey and Sussex Healthcare NHS Trust
Information provided by (Responsible Party):
King's College London

Brief Summary:

The complex relationship that exists between physical and mental health in prostate cancer is increasingly being understood. Psychiatric symptoms are common in this group and have important consequences for the quality of life and cancer outcomes for patients with prostate cancer. However, less is understood about the severity of disease and which patient factors and treatment options are risk factors for developing problems. Additionally, the impact these conditions have on problems such as urinary incontinence or sexual function is less well understood. The investigators anticipate that different patient characteristics and treatment options increase an individuals risk of developing problems after a prostate cancer diagnosis. Therefore, this study aims to further investigate these specific factors to improve follow up care in patients with prostate cancer.

This observational study will follow up newly diagnosed prostate cancer patients for a period of 12 months to evaluate these outcomes. Participants will be identified across seven hospitals in London and South England. After being recruited participants will be invited to undergo repeated online or postal questionnaires at baseline, 3, 6, 9 and 12 months. These will assess depressive and anxiety symptom load, body image issues, fear of recurrence, masculinity perception and functional symptoms (including urinary, bowel and sexual symptoms) load.

Analysis of these findings will allow for identification of 1) Which subgroups of patients appear to have worse mental wellbeing and quality of life outcomes, and 2) How mental health issues impact functional outcomes. This will provide important information for guiding future research within the subject area and further inform clinicians about these issues.


Condition or disease
Prostate Cancer

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Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective and Longitudinal Cohort Study Assessing Mental wellbeIng and Quality of Life in Prostate Cancer - the MIND-P Study
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Radical Prostatectomy
Participants undergoing any curative surgical treatment option for prostate cancer irregardless of approach (open, laparoscopic or robotic)
Active Surveillance
Participants undergoing active surveillance as the management option for prostate cancer as defined by regular surveillance attendance at the primary treating site.
Androgen Deprivation Therapy
Participants undergoing medical (Gonadotropin-releasing hormone (GnRH) agonists or antagonists) or surgical castration (e.g. orchidectomy) options as the primary treatment for prostate cancer.
Radical Radiotherapy
Participants undergoing primary radiotherapy treatment for prostate cancer irregardless of delivery methods (e.g. External beam radiation therapy or brachytherapy).



Primary Outcome Measures :
  1. Mean difference of mental wellbeing measures between four management groups [ Time Frame: Baseline, 3, 6, 9 and 12 months post diagnosis ]
    Mental wellbeing validated tools scores including Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Body Image Scale, Fear of Recurrence Scale, Masculine Self-Esteem Prostate Cancer-Related Quality of Life (PC-QOL) Subset Scale and Short Form-12 Mental Component Scale (SF-12 MCS)


Secondary Outcome Measures :
  1. Cumulative incidence of significant depressive or anxiety symptoms stratified per treatment cohort [ Time Frame: 12 Months ]
    Binary outcome of the development of significant depressive or anxiety symptoms as defined by PHQ-9 or GAD-7 Score ≥ 10

  2. Mean difference of mental wellbeing measures within same treatment group at each follow up time [ Time Frame: Baseline, 3, 6, 9 and 12 months post diagnosis ]
    Mental wellbeing validated tools scores including PHQ-9, GAD-7, Body Image Scale, Fear of Recurrence Scale, Masculine Self-Esteem PC-QOL Subset Scale and SF-12 MCS

  3. Relationship between depression and anxiety scores and other mental wellbeing and functional outcome scores stratified per treatment cohort [ Time Frame: Baseline, 3, 6, 9 and 12 months post diagnosis ]
    Depression (PHQ-9) and Anxiety (GAD-7) scores evaluated against other mental wellbeing measures (Body Image Scale, Fear of Recurrence Scale, Masculine Self-Esteem PC-QOL Subset Scale, SF-12 MCS), social wellbeing (Functional Assessment of Cancer Therapy - General Social Wellbeing Subset) and functional outcome scores (All Expanded Prostate Cancer Index Composite-26 Subsets and Short Form-12 Physical Component Scale)

  4. Risk of developing significant depressive or anxiety symptoms per clinical or baseline patient characteristics [ Time Frame: Baseline, 3, 6, 9 and 12 months post diagnosis ]
    Baseline and patient (Age at diagnosis, ethnicity, co-morbidities burden, previous mental health history, family history of prostate cancer) and oncological characteristics (Mode of diagnosis, Gleason grade, Prostate Specific Antigen (PSA), stage at diagnosis) evaluated against binary outcome for the development of significant depressive or anxiety symptoms (PHQ-9 and GAD-7 Score ≥ 10)


Other Outcome Measures:
  1. Subgroup analysis on individual treatment cohorts evaluating the impact of significant depression and anxiety symptoms on oncological outcomes [ Time Frame: 12 Months ]
    Development of significant depressive or anxiety symptoms (PHQ-9 and GAD-7 Score ≥ 10) evaluated against oncological or treatment outcomes (o Positive Surgical Margins (for radical prostatectomy cohort), Biochemical progression, conversion from active surveillance to active treatment)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population of study are patients with a recently newly confirmed diagnosis, or clinically likely diagnosis of prostate cancer in a secondary care setting. Four separate sub-cohorts based on treatment or management allocated will be recruited with identical inclusion and exclusion criteria, with the exception of treatment specific characteristics. The four cohorts to be recruited will be newly diagnosed men with prostate are those described in the eligibility criteria.
Criteria

Inclusion Criteria:

  • New diagnosis of histologically proven or clinically likely prostate cancer

    • No limits on grade, histology type or risk stratification classification
  • Post Multi Disciplinary Team discussion with allocation of a suggested treatment or follow up strategy
  • Undergoing one of the following four treatment/management options:

    • Radical Prostatectomy
    • Radiotherapy (External beam radiation therapy or brachytherapy)
    • Active Surveillance
    • Androgen Deprivation Therapy (Medical or Surgical castration)
  • Follow up undertaken by urology, oncology or mixed uro-oncology teams

Exclusion Criteria:

  • Patient is pre-Multi Disciplinary Team discussion
  • Patient has already undergone the allocate intervention

    • Post-surgery
    • Post first radiotherapy dose
    • Attended second active surveillance follow up
    • Received >1 dose (initial dose) of Gonadotropin-releasing hormone agonist/antagonist
  • Patients receiving the following therapies:

    • Palliative patients on symptom control only
    • Patients allocated to watchful waiting
    • Any type of Focal therapy e.g. high intensity focused ultrasound (HIFU)
    • Patients receiving adjuvant combination therapy e.g. Androgen deprivation therapy or chemotherapy pre radiotherapy or surgery
    • Metastatic patients undergoing chemotherapy alone
  • Patients presenting with recurrence or progression of prostate cancer
  • Concurrent management for another cancer diagnosis
  • Recent admission to an inpatient psychiatric facility within the previous 12 months prior to diagnosis of prostate cancer
  • Patients lacking capacity to consent or undertake in the research
  • Those unable to complete the required surveys, such as those not able to understand English or those with severe learning disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647474


Contacts
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Contact: Oliver Brunckhorst, MBBS, MRCS +447434672408 Oliver.brunckhorst@kcl.ac.uk
Contact: Kamran Ahmed, MBBS, FRCS +44207 188 5906 kamran.ahmed@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Not yet recruiting
London, Greater London, United Kingdom, SE1 9RS
Contact: Oliver Brunckhorst, MBBS, MRCS    +447434672408    Oliver.brunckhorst@kcl.ac.uk   
Contact: Kamran Ahmed, MBBS, PhD    +44207 188 5906    kamran.ahmed@kcl.ac.uk   
Sub-Investigator: Prokar Dasgupta         
Lewisham and Greenwich NHS Trust Not yet recruiting
London, Greater London, United Kingdom, SE18 4QH
Contact: Oliver Brunckhorst, MBBS, MRCS    +447434672408    Oliver.brunckhorst@kcl.ac.uk   
Contact: Kamran Ahmed, MBBS, FRCS    +44207 188 5906    kamran.ahmed@kcl.ac.uk   
Sub-Investigator: Mohamed Hammadeh         
King's College Hospital NHS Foundation Trust Recruiting
London, Greater London, United Kingdom, SE5 9RS
Contact: Oliver Brunckhorst, MBBS, MRCS    +447434672408    Oliver.brunckhorst@kcl.ac.uk   
Contact: Kamran Ahmed, MBBS, FRCS    +44207 188 5906    kamran.ahmed@kcl.ac.uk   
Imperial College Healthcare NHS Trust Not yet recruiting
London, Greater London, United Kingdom, W2 1NY
Contact: Oliver Brunckhorst, MBBS, MRCS    +447434672408    Oliver.brunckhorst@kcl.ac.uk   
Contact: Kamran Ahmed, MBBS, FRCS    +44207 188 5906    kamran.ahmed@kcl.ac.uk   
Sub-Investigator: Hashim Ahmed         
Medway NHS Foundation Trust Not yet recruiting
Gillingham, Kent, United Kingdom, ME7 5NY
Contact: Oliver Brunckhorst, MBBS, MRCS    +447434672408    Oliver.brunckhorst@kcl.ac.uk   
Contact: Kamran Ahmed, MBBS, FRCS    +44207 188 5906    kamran.ahmed@kcl.ac.uk   
Sub-Investigator: Matin Sheriff         
Surrey and Sussex Healthcare NHS Trust Not yet recruiting
Redhill, Surrey, United Kingdom, RH1 5RH
Contact: Oliver Brunckhorst, MBBS, MRCS    +44 7434672408    Oliver.brunckhorst@kcl.ac.uk   
Contact: Kamran Ahmed, MBBS, FRCS    +44207 188 5906    kamran.ahmed@kcl.ac.uk   
Sub-Investigator: Shahid Khan         
Sponsors and Collaborators
King's College London
King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Imperial College Healthcare NHS Trust
Medway NHS Foundation Trust
Lewisham and Greenwich NHS Trust
Surrey and Sussex Healthcare NHS Trust
Investigators
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Principal Investigator: Kamran Ahmed, MBBS, FRCS King's College London
Additional Information:
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04647474    
Other Study ID Numbers: 284473
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised individual participant data pertaining to any analysis conducted by this research will be made available publicly without restriction after the conductance of the study through the King's Research Data Repository.
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: All raw data will be made available by the time of publication of the research study in a peer reviewed journal. This will be archived for a duration of 20 years.
Access Criteria: Openly available through the King's Research Data Repository.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Prostate Cancer
Depression
Anxiety
Mental Wellbeing
Functional Outcomes
Social Wellbeing
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases