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T-CBSM for Prostate Cancer (PC-CHIP Trial)

N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t1), 6-months post-baseline (t2), and 12-months post-baseline (t3)
Awards & highlights

PC-CHIP Trial Summary

The purpose of this study is to examine the effects of various factors such as emotions, stress, stress management techniques (for example relaxation and coping techniques), and health information on quality of life, distress, depression, coping, and physical health in men diagnosed with advanced prostate cancer. The investigators also evaluate the effectiveness of a 10-week group-based internet delivered psychosocial intervention. Primary outcomes are symptom burden (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical & social functioning). Participation in this study includes three face-to-face assessments: baseline (at the beginning of the research study), 6-month follow-up, and 12-month follow-up. The 6- and 12-month follow-up interviews are conducted after the participant has completed the 10-week group intervention. Participants are randomized into either an intervention group (targets stress management skills - relaxation, coping) or a control group (health information and health promotion strategies - benefits of proper nutrition and treatment compliance). Both groups meet for 10 consecutive weeks through an internet video conferencing platform. At the baseline, 6- and 12-month follow-ups, the investigators collect blood and saliva samples. The blood samples go through a three-day process in which the investigators extract and store serum, plasma, and cells for further analysis and gather proliferation data. The investigators use the saliva to measure the cortisol diurnal rhythm.

Eligible Conditions
  • Prostate Cancer

PC-CHIP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t1), 6-months post-baseline (t2), and 12-months post-baseline (t3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1), 6-months post-baseline (t2), and 12-months post-baseline (t3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HRQOL from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).
Change in symptom burden from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).
Other outcome measures
Distress & Positive/Negative Affect
Interpersonal Disruption
Neuroimmune Regulation
+1 more

PC-CHIP Trial Design

2Treatment groups
Active Control
Group I: T-CBSMActive Control1 Intervention
Technology based cognitive behavioral stress management.
Group II: T-HPActive Control1 Intervention
Technology based health promotion (control condition)

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,027 Total Patients Enrolled
19 Trials studying Prostate Cancer
2,735 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,681 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,871 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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~17 spots leftby Apr 2025