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

A Prospective and Longitudinal Cohort Study Assessing Mental wellbeIng and Quality of Life in Prostate Cancer - the MIND-P Study

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

Detailed Description

Prostate cancer represents a large proportion of global cancer incidence, accounting for 13.5% of all male cancers. However, with high survival rates, which are still improving, there is growing acceptance that living longer does not always equate to living well. The mental health aspect of the disease is unfortunately sometimes neglected with research focusing on the physical symptoms after disease much more prominent and frequently conducted. Previous research has already demonstrated that mental health issues are common in patient with prostate cancer, however, less is known about which patients are at greater risk of developing problems after being diagnosed with prostate cancer. Additionally, the association between mental health conditions and what are called 'functional outcomes' (i.e. bladder, bowel and sexual function) after treatment are less well understood. A greater knowledge of these factors can help clinicians to make better assessments of patients and also will help the future development of additional tools which are able to help with diagnosis in future.

With these factors in mind the primary aims of the research study is :

1. To evaluate the association between prostate cancer patients undergoing different treatments and overall mental wellbeing in the initial cancer follow-up stage.

The secondary aims of the study are to:

1. Identify high risk time-frames post diagnosis for worsening of mental wellbeing
2. Assess the impact of depressive and anxiety symptoms on functional, clinical and other mental wellbeing outcomes.
3. Explore patient and cancer related factors conferring a risk for the development of significant mental wellbeing problems.

The investigators hypothesis is that prostate cancer patients experience a high psychological symptom load in the initial follow up period after diagnosis. Additionally, based on previous prostate cancer and mental health research the investigators hypothesise that certain subgroups (e.g. certain treatment or patient groups) are at increased risk of developing significant psychological symptoms.

To explore these aims and hypothesis the investigators will conduct a questionnaire based, longitudinal and observational cohort study of participants recently diagnosed with prostate cancer. There is no interventional element to the study. The investigators will identify newly diagnosed patients, who have not yet received treatment from multiple hospital sites in London and the South East of England. This will include patients allocated to surgery, radiotherapy, surveillance or hormone therapy depending on prostate cancer characteristics. Participants will be identified by the clinical team during the hospital outpatient appointment, with contact details taken at this stage. The investigators are aiming to recruit 300 participants for this study based on power calculations (80% power with 0.05 significance) for the primary outcomes taking into account a maximum drop out rate of 25%.

Following identification, screening and consenting for inclusion into the study participants will begin data collection through serial questionnaires. Participants will have the option of either undergoing postal or electronic follow up, depending on preference. Questionnaires will include numerous validated measures to evaluate mental and social wellbeing as well as functional symptoms of disease/treatment including bladder, bowel and sexual function as per the outcome measures described.

Collection of data will occur at set intervals for the duration of the study and will include the same questionnaire being filled at the beginning of the study, 3, 6, 9 and 12 months. Additionally, at the outset of the study some further information will be asked from the participant including demographics and previous medical or psychiatric history. The research team will in addition collect data from the medical files at the beginning of the study about the cancer characteristics and then again at the end of the study at 12 months. At 12 months participants will complete the study and data analysis along the primary and secondary outcome measures will be conducted once all participants have completed this.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK42 9DJ
      • Bedfordshire Hospitals NHS Foundation Trust
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • King's College Hospital NHS Foundation Trust
    • London, Greater London, United Kingdom, W2 1NY
      • Imperial College Healthcare NHS Trust
    • London, Greater London, United Kingdom, SE1 9RS
      • Guy's and St Thomas' NHS Foundation Trust
    • London, Greater London, United Kingdom, SE18 4QH
      • Lewisham and Greenwich NHS Trust
  • Kent
    • Gillingham, Kent, United Kingdom, ME7 5NY
      • Medway NHS Foundation Trust
  • Surrey
    • Redhill, Surrey, United Kingdom, RH1 5RH
      • Surrey and Sussex Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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.
Hormone Monotherapy; Participants undergoing medical hormone therapy (Antiandrogens and 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference of mental wellbeing measures between four management groups	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 and Masculine Self-Esteem Prostate Cancer-Related Quality of Life (PC-QOL) Subset Scale	Baseline, 3, 6, 9 and 12 months post diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of significant mental wellbeing outcomes	Binary outcome of the development of significant individual mental wellbeing outcomes (depression, anxiety, body image issues, masculinity and fear of cancer recurrence)	12 Months
Exploration of prognostic factors of mental wellbeing outcomes.	Pre-selected patient, oncological and treatment factors evaluated against each individual mental wellbeing outcome for exploration of potentially prognostic factors for significant symptom development.	Within 12 months of diagnosis
Relationship between each individual mental wellbeing symptom and functional/social wellbeing.	Functional outcomes will include sexual, urinary and bowel symptoms from EPIC-26. Social wellbeing will include FACT-G subscale scores with general health defined using the SF-12 physical component score.	At 12 months post diagnosis.
Evaluation of effect of time on symptoms	Evaluate the trajectory of mental wellbeing symptoms over a 12-month period and effect of time on symptom scores.	Within 12 months of diagnosis

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup analysis on individual treatment cohorts evaluating the impact of significant depression and anxiety symptoms on oncological outcomes	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)	12 Months

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: King's College Hospital NHS Trust; Guy's and St Thomas' NHS Foundation Trust; Imperial College Healthcare NHS Trust; Lewisham and Greenwich NHS Trust; Medway NHS Foundation Trust; Surrey and Sussex Healthcare NHS Trust; Bedfordshire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Kamran Ahmed, MBBS, FRCS, King's College London

Publications and helpful links

Helpful Links

• Study Website

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Prostate Cancer; Functional Outcomes; Mental Wellbeing; Social Wellbeing
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 284473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Openly available through the King's Research Data Repository.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No