Clinical trial NCT04647474: Mental Wellbeing and Quality of Life in Prostate Cancer
Official title: A Prospective and Longitudinal Cohort Study Assessing Mental wellbeIng and Quality of Life in Prostate Cancer - the MIND-P Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Depression
Anxiety
Mental Wellbeing
Functional Outcomes
Social Wellbeing
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
name: Guy's and St Thomas' NHS Foundation Trust
name: Imperial College Healthcare NHS Trust
name: Medway NHS Foundation Trust
name: Lewisham and Greenwich NHS Trust
name: Surrey and Sussex Healthcare NHS Trust
name: Bedfordshire Hospitals NHS Foundation Trust
First posted: 2020-12-01
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean difference of mental wellbeing measures between four management groups
timeFrame: Baseline, 3, 6, 9 and 12 months post diagnosis
Secondary outcomes:
measure: Cumulative incidence of significant mental wellbeing outcomes
timeFrame: 12 Months
measure: Exploration of prognostic factors of mental wellbeing outcomes.
timeFrame: Within 12 months of diagnosis
measure: Relationship between each individual mental wellbeing symptom and functional/social wellbeing.
timeFrame: At 12 months post diagnosis.
measure: Evaluation of effect of time on symptoms
timeFrame: Within 12 months of diagnosis
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: Bedfordshire Hospitals NHS Foundation Trust
state: Bedfordshire
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
state: Greater London
city: London
country: United Kingdom
facility: Lewisham and Greenwich NHS Trust
state: Greater London
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: Greater London
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: Greater London
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
state: Kent
city: Redhill
country: United Kingdom
facility: Surrey and Sussex Healthcare NHS Trust
state: Surrey
Study officials:
affiliation: King's College London
name: Kamran Ahmed, MBBS, FRCS
role: PRINCIPAL_INVESTIGATOR
References: