Cognitive Health for Prostate Cancer Survivors

Not currently recruiting at 6 trial locations

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Alzheimer's, Dementia, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how prostate cancer survivors experience cognitive difficulties, such as problems with thinking and remembering, and how these might relate to conditions like anxiety, depression, and trouble sleeping. Researchers seek to determine if factors like social support and cancer treatment types affect these cognitive issues. The study involves a one-time survey to gather this information. It is suitable for English-speaking individuals who have survived prostate cancer and currently show no signs of the disease. As an unphased trial, this study offers participants the opportunity to contribute to a deeper understanding of cognitive challenges faced by survivors, potentially improving future care.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the PROMIS-SF v2.0 - Cognitive Function 8a tool because it offers a fresh approach to understanding cognitive health in prostate cancer survivors. Unlike traditional methods that might require lengthy assessments or complex procedures, this tool enables a straightforward, efficient evaluation of cognitive function via surveys. Additionally, the use of secure, HIPAA-compliant text messaging for communication and survey completion ensures that participants can engage easily and securely, potentially leading to more accurate and representative data collection. This streamlined approach has the potential to provide new insights into cognitive health, helping to tailor future interventions more effectively.

What evidence suggests that this method is effective for understanding cognitive dysfunction in prostate cancer survivors?

Research shows that the PROMIS-SF v2.0 - Cognitive Function 8a effectively assesses the brain health of prostate cancer survivors. It evaluates the frequency of issues such as memory problems or difficulty concentrating. Studies using this tool have found it reliable and consistent in identifying these symptoms. This helps researchers understand the mental challenges faced by prostate cancer survivors. Although not a treatment, the information gathered can aid in identifying and managing cognitive problems related to cancer survival. ^{1 2 3 4 5}

Who Is on the Research Team?

Kevin Liou

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

English-speaking

History of histologically documented PC of any stage

No evidence of PC Disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants complete surveys to assess cognitive function and co-morbid symptoms

1 day

1 visit (virtual)

Follow-up

Participants are monitored for any additional data collection needs or survey completion

1 year

What Are the Treatments Tested in This Trial?

Interventions

• PROMIS-SF v2.0 -Cognitive Function 8a

How Is the Trial Designed?

Group I: Survivors of Prostate Cancer Experimental Treatment 1 Intervention

This is a cross-sectional study with a one-time data collection process and no subsequent follow-ups. If patients did not opt out of receiving study-specific text communications, they may also receive text messages with reminders about surveys and/or direct links to REDCap to complete the surveys. Text-based communications will be delivered using the secure, HIPAA-compliant Mosio texting platform developed for clinical research.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05540782

A Study of Cognitive Health in Survivors of Prostate Cancer All participants will be evaluable as long as they have completed the PROMIS-SF v2.0 - Cognitive Function 8a. 1 year. Collaborators and Investigators. This is ...

2. onf.ons.org onf.ons.org/publications-research/onf/52/2/identification-symptom-profiles-prostate-cancer-survivors

Identification of Symptom Profiles in Prostate Cancer ... The Patient-Reported Outcomes Measurement Information System Short Form v2.0 Cognitive Function 8a assesses the frequency of cognitive ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12056817/

Identification of Symptom Profiles in Prostate Cancer ... The Patient-Reported Outcomes Measurement Information System Short Form v2.0 Cognitive Function 8a assesses the frequency of cognitive ...

4. researchgate.net researchgate.net/publication/287149697_Evaluation_of_the_Psychometric_Properties_of_the_PROMIS_Cancer_Fatigue_Short_Form_with_Cancer_Patients

Evaluation of the Psychometric Properties of the PROMIS ... ... The PROMIS-29 is a reliable measure of symptom experiences among cancer patients with good internal consistency and convergent validity ( ...

5. healthmeasures.net healthmeasures.net/images/PROMIS/manuals/PROMIS_Cognitive_Function_Scoring_Manual.pdf

COGNITIVE FUNCTION For the adult PROMIS v2. 0 Adult Cognitive Function 4a short form, a raw score of 10 converts to a T-score of 37.69 with a standard error (SE) ...