Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

University of Miami

Status: Completed

Conditions: Stress

Treatments: Behavioral: Psychoeducational Control; Behavioral: Cognitive behavioral stress management

Study type: Interventional

Funder types: Other

Identifiers

NCT05486754

19990288

1P50CA084944 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to test a stress management program for men with early-stage prostate cancer.

Enrollment: 260 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men who had undergone either a radical prostatectomy or radiation therapy (i.e., external beam or seed implant) for stage I or II prostate cancer in the preceding 18-months
• 50 years of age or older
• Ability to speak, read, and write in English
• Having a ninth grade reading level or greater
• Being free of cognitive impairment that would interfere with the study
• No active psychiatric symptoms in the previous three months.

Exclusion criteria

• Previous history of non-skin cancer
• Have received adjuvant treatment, including hormone treatment, for prostate cancer

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Cognitive behavioral stress management group

Experimental group

Description:

Participants received the cognitive behavioral stress management intervention for 10 weeks.

Treatment:

Behavioral: Cognitive behavioral stress management

Health promotion group

Active Comparator group

Description:

Participants received the health promotion group for one day.

Treatment:

Behavioral: Psychoeducational Control