Condition category
Cancer
Date applied
26/06/2019
Date assigned
22/11/2019
Last edited
22/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The diagnosis process for suspected prostate cancer is emotionally straining for patients and may, in itself, have negative health implications. Considerable variability in waiting-time during the diagnosis processes exists, but data are scarce on how it may affect the patients’ distress level. In this clinical trial, we aim to compare stress-related symptoms and biomarkers during the diagnostic workup process among men with suspected prostate cancer who are randomized to either a fast-track diagnostic workup process or to usual care workup at the Urology Department at Örebro University Hospital in Sweden.

Who can participate?
Males aged 85 years or less with suspected prostate cancer referred to the Urology Department at Örebro University Hospital.

What does the study involve?
The study involves randomization of men with suspected prostate cancer to either a fast-track diagnostic workup process or to usual care diagnostic workup. The participants’ stress levels are assessed at different time points during and after the diagnostic workup process, using questionnaires focused on self-reported symptoms of distress (anxiety, depression, distress, sleep disruption). Stress levels are further characterized through the repeated collection of saliva samples for assessment of diurnal cortisol patterns as well as thumb-ECGs for measurement of heart rate variability.

What are the possible benefits and risks of participating?
The possible benefits and risks of participating relate to reduced or increased stress levels and the potentially stress-linked health risk, respectively. The variation in duration of the workup and related potential treatment delay is not expected to influence the disease course.

Where is the study run from?
Örebro University Hospital, Sweden

When is the study starting and how long is it expected to run for?
April 2015 to December 2021

Who is funding the study?
Swedish Cancer Foundation

Who is the main contact?
Dr Katja Fall
Katja.Fall@oru.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katja Fall

ORCID ID

http://orcid.org/0000-0002-3649-2639

Contact details

Södra Grev Rosengatan
Örebro
70185
Sweden
+46 (0)19-6023162
Katja.Fall@oru.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

266361 (FOU ÖREBRO)

Study information

Scientific title

Prostate cancer Stress Surveillance and Survival (ProCeSS): evaluation of a fast-track clinical workup for men with suspected prostate cancer

Acronym

ProCeSS

Study hypothesis

Waiting time during diagnostic workup for suspected prostate cancer effects psychological and physiological measures of stress relevant to health and disease

Ethics approval

Approved 11/11/2014, Ethics review board Örebro University Hospital (Örebro läns landsting, Box 1613, 701 16, Örebro, Sweden; Registrator@uppsala.epn.se; +46 18 4717400) ref: 2014/348/1

Study design

Randomized clinical trial double-blind single-centre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web-format, please use contact details to request a participant information sheet.

Condition

Prostate cancer

Intervention

Men with suspected prostate cancer are randomized to regular or fast-track diagnostic work-up.

The fast-track intervention entails a diagnostic workup process where the shortest possible waiting-time is targeted: 1 week between randomization and the urologist visit with biopsy (if needed), 1 week between biopsy and diagnosis, and 1 week between diagnosis and treatment decision. The usual care group has waiting-times of approximately 1 week to 3 months, about 2 weeks, and 2 weeks during these steps, respectively. Men in both arms are first assessed at the urology clinic directly after randomization and again during a first urologist visit where a diagnostic biopsy is taken. Subsequent assessments are made 1, 6 and 12 months after randomization.

Written informed consent is obtained by a research nurse before participants are randomized to either fast-track workup or to usual care. Group assignment cards, which have been randomly placed into sealed envelopes, are drawn for allocation of management. All participants are informed that their experience of the diagnostic work-up process is assessed, and that they will be blinded with regard to study group. A research nurse registers the assignment group and arranges the workup process according to the assigned management. The assigned treatment group is therefore not revealed to either urologist or patient.

Intervention type

Other

Phase

Drug names

Primary outcome measure

At baseline, 1, 6 and 12 months:
1. Depression and anxiety with the Hospital Anxiety and Depression Scale (HADS)
2. Self-evaluated distress with the National Comprehensive Cancer Network (NCCN) distress thermometer
3. Sleep quality and disturbances through the Åkerstedts Karolinska Sleep Questionnaire

Secondary outcome measures

At baseline, 1, 6 and 12 months:
1. Heart rate variability measured using thumb-ECG
2. Diurnal cortisol level measured using saliva cortisol

Overall trial start date

06/11/2014

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Referred to the Urology Department at Örebro University Hospital for suspected prostate cancer
2. Male
3. Aged 85 years or younger
4. Able to speak and write Swedish

Participant type

Patient

Age group

Mixed

Gender

Male

Target number of participants

400

Participant exclusion criteria

1. Signs of advanced prostate cancer. Metastatic prostate cancer and cancer with prostate-specific antigen level (PSA) >100 mg/l are defined as advanced prostate cancer
2. Severe psychiatric or somatic diseases
3. Any other malignancy

Recruitment start date

14/04/2015

Recruitment end date

31/12/2021

Locations

Countries of recruitment

Sweden

Trial participating centre

Örebro University Hospital
Södra Grev Rosengatan
Örebro
70185
Sweden

Sponsor information

Organisation

Örebro University Hospital

Sponsor details

Urology Deparment
Södra Grev Rosengatan
Örebro
70185
Sweden
+46 196021000
info@regionorebrollan.se

Sponsor type

Hospital/treatment centre

Website

https://www.regionorebrolan.se/sv/uso/Patientinformation/Kliniker-och-enheter/Urologiska-kliniken/

Funders

Funder type

Charity

Funder name

Swedish Cancer Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Sweden

Results and Publications

Publication and dissemination plan

Peer-reviewed international scientific journals.

A protocol written in Swedish can be made available upon request from the study contact.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/01/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/10/2019: Trial’s existence confirmed by Regionala Etikprövningsnämnden Uppsala.