Gonadotropin-releasing hormone (GnRH) agonists, also known as luteinizing hormone-releasing hormone (LHRH) agonists, are the leading treatment for advanced prostate cancer (PCa) and are increasingly used as a therapy in earlier stages of the disease. GnRH agonist therapy produces hypogonadism with the intent to slow disease progression but makes men vulnerable to adverse physical, mood, and sexual symptom clusters. Behavioral interventions are urgently needed to ameliorate the effects of GnRH agonist symptom clusters on health related quality of life (HRQOL) for men with PCa. No racial group in the U.S. has a higher PCa incidence, higher risk of advanced PCa, or is likely to be affected more by the increased use of GnRH agonists in treating the disease than African Americans. Thus, our study is designed specifically for AA men with PCa receiving GnRH agonist treatment and their partners. We propose testing a Telephone Interpersonal Counseling (TIP-C) symptom management intervention. In several studies with breast cancer patients and their partners, TIP-C, including social support and information on cancer disease and treatment reduced depression, anxiety, fatigue, and stress and improved HRQOL. We pilot-tested TIP-C in African American men with PCa receiving GnRH agonists and their partners with results that suggested postive influences on some aspects of mood and HRQOL. The purpose of this randomized study is to conduct a protocol feasibility and pilot test comparing GnRH agonist symptom clusters and HRQOL in African American men with PCa receiving telephone delivered symptom management interventions in two formats. A sample of 60 African American men with PCa beginning GnRH agonist therapy and their partners (N=120) will be randomized as dyads to multimodal TIP-C, including a home resistance exercise program for the PCa patient, or to telephone information only. The study will include biobehavioral measures sensitive to GnRH agonist symptom clusters to include physical cluster symptoms (muscle atrophy, obesity, dyslipidemia, hyperglycemia), mood cluster symptoms (anxiety, depression, anger, fatigue), and sexual cluster symptoms (low libido, erectile dysfunction, hot flashes) with a focus on general and prostate cancer specific HRQOL outcomes.
African American men have the highest rate of prostate cancer in the world, twice the risk of being diagnosed in late stage prostate cancer, and are 2 to 3 times more likely to die of the disease as compared to white men. Georgia is one of the five states with an African American population over 2 million. The research team at the Medical College of Georgia is well prepared and positioned to involve African Americans in highly significant prostate cancer symptom management research, develop a research protocol that assures cultural competence, and have a profound impact on a rapidly growing area of concern in public health. ? ? ? ?
