Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID: NCT03149185
Run by: Northwestern University
People needed: 224
Starts: 2012-05-25
Expected to finish: 2018-04-22
Last updated by the study team: 2023-11-22

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

≥ 50 years of age
Fluent in spoken English (6th grade level required to complete assessments and participate in groups)
Diagnosis of Stage III or IV (T3/N1/ M0-T4/N3/M1) prostate cancer
Received HT, or HT and RT treatment within the past year or is currently receiving HT, or HT and RT
Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review
Willingness to be randomized and followed for 12 months

You may not qualify if…

Received treatment for a type of cancer other than prostate or skin cancer within the past 5 years or is currently receiving treatment for a cancer other than prostate or skin
Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis), as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review
Active alcohol abuse or dependence OR inpatient treatment for alcohol abuse within the last 6 months may be exclusionary, per P.I. discretion
Active substance abuse or dependence OR inpatient treatment for substance abuse within the last 6 months may be exclusionary, per P.I. discretion
Acute or chronic immune system medical conditions, medications or other conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Sjogren's disease, SLE, Hepatitis C, or any immunosuppressive treatment requiring conditions)
Life expectancy <12 months.

Where it is running

Jesse Brown VA Medical Center — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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