Decision Making Under Uncertainty in Prostate Cancer

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Study Abstract Treatment decision-making in men newly diagnosed with early stage prostate cancer is difficult due to the options for treatments, each with similar benefits and possible side effects that are potentially difficult (Krisch & Koprowski, 2000). Physicians must discuss these options with newly diagnosed patients during the treatment consultation and patients often lack communication skills necessary for treatment consultation. This NIH-funded study will determine whether an intervention that combines information on treatment choices and communication skills training is useful for newly diagnosed patients with prostate cancer. It is anticipated that this intervention will improve patients’ participation with their physician in decision making and their satisfaction with treatment choice. The decision-making uncertainty management intervention is designed to help Caucasian and African-American men with localized prostate cancer gain the knowledge and skills needed in order to be an active participant in treatment decision-making with their physician. The specific aims of the study are: (1) to examine the effects of a decision-making uncertainty management intervention on appropriate outcomes; and (2) to determine which patients benefit the most from the intervention. The proposed study will be a randomized controlled trial. Participants will be 120 Caucasian and 120 African-American men diagnosed with localized prostate cancer and randomly assigned to the treatment groups or the control condition. Once subjects provide informed consent, baseline data collection will be done by telephone. The intervention begins once the patient receives the information booklet and the communication skills training videotape and will continue for about 7-10 days. The telephone intervention has two key foci—providing information about prostate cancer treatment via an investigator-developed booklet sent to men in the intervention groups and teaching communication skills on a videotaped training program sent to subjects. All patients in the treatment group will receive this intervention. Subjects in the control group will receive general information about staying healthy during cancer treatment. Measurement of outcomes will occur at three points for all participants: baseline, when the patient enters the study after receiving a diagnosis of localized prostate cancer (T1); 4 weeks post baseline, immediately after the patient-physician treatment decision-making meeting occurs (T2); and 3 months after prostate cancer treatment has been initiated (T3). In addition to the prostate cancer patient, physicians are asked to sign consents to be subjects since they are requested to complete a questionnaire about how they generally handle uncertainty in interactions with patients with prostate cancer. Men will be eligible to enter the study after they have received a diagnosis of localized prostate cancer and have not yet decided on a treatment option. A study site coordinator will be identified at each clinical site and will be the person introducing the study to patients and identifying eligible men. At some sites, physicians or nurses will inform the patient about the study and ask him if he is interested in participating. If the patient is interested in joining the study, his name and phone number is forwarded to the research office. He will be called by our recruiter and provided with further information about the study. If the patient agrees, the study recruiter will send the consent in overnight mail to the patient and family member and will be call back the next day to obtain their formal consent. Following the completion of the intervention, when the patient meets with doctor, the doctor-patient treatment consultation is audio-taped. The study will have been reviewed and approved by the IRB at each clinical site. The risks to subjects in this study are minimal. This research study is funded from 9/30/02 – 6/30/06 by the National Institutes of Health and National Institute of Nursing Research.