Patient Reported Outcome Measurements (PROMs)
OtherPatient Reported Outcome Measurements collected via questionnaire
NCT Number: NCT07529418
The BALANCE study is a prospective Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.
Participants in this study will be asked to complete a questionnaire (either electronically or hardcopy) to share their insights following their PCa diagnosis.
Trial opening soon.
Get Notified18 year and older
Male
Observational
The BALANCE study is a Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study is a questionnaire based study collecting data through electronic surveys. The study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.
The study will recruit a minimum of 800 participants who will be asked to complete an electronic survey. Participants will be aged 18 years or over and have had a prostate cancer diagnosis. All participants will be asked to provide informed consent before proceeding with the survey. After consenting, participants will be able to access the electronic survey. Participants will have the opportunity to save their results and access the survey across multiple sessions if not able to complete in one sitting. However, they will be asked to complete the survey only once.
Potential participants will be identified through collaboration with cancer charities, support groups, hospitals, study advertisements in the press, use of social media (in collaboration with the European Association of Urology Patient Office, the funders of the study), outreach work in communities, presentations, cancer alliances, posters/leaflets and animation videos about the study that could be displayed in hospitals, public spaces and other community organisations. Participants will be able to either contact the study team, their associated cancer charity or support group to express interest in taking part in this study and receive further information.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Patient Reported Outcome Measurements collected via questionnaire
Time frame: 18 months
Impact of prostate cancer on quality of life (measured through EORTC-QLQ-C30): overall health score, overall QoL score.
Time frame: 18 months
Physical impact of treatments on quality of life (measured through EPIC-26): sexual function, urinary function; bowel function; hormonal related symptoms.
Time frame: 18 months
Impact of treatments in mental health outcomes (measured through EORTC-QLQ-C30): anxiety, depression, financial worries.
Time frame: 18 months
Functional impact of treatments on QoL (measured through EORTC-QLQ-C30): energy levels, physical activity.
Time frame: 18 months
Variation in physical, mental health and functional outcomes by treatment type and sociodemographic characteristics.
Time frame: 18 months
Usability and acceptance of ePROMs by patients and healthcare providers.
Time frame: 18 months
Identification of barriers and facilitators to successful ePROMs implementation.
Contact information is provided by the study sponsor or research team.
Denzil James, MSc
CONTACT
Esther Robijn
CONTACT
Institute of Cancer Research, United Kingdom
Other
BlAck and Mixed Men's Lived Experience With Prostate cANCEr - Diversity in Prostate Cancer PROMS Study
Acronym: BALANCE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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