- Primary Investigator:
William Dale - Primary Location:
University of Chicago, Department of Medicine - Grant Type & Year:
IIG 2009
Purpose
Specific Aims: The overall goal is to improve decision-making regarding the initiation of androgen-deprivation therapy (ADT) for men with biochemical recurrence (BCR) of prostate cancer (PCA). We will do this through lowering patients’ anxiety, decreasing decision conflict, improving patient knowledge and, thereby, influencing the shared decision about the timing of ADT initiation. The purpose of this study is to conduct a randomized study of the impact of a previously-developed Informed Medical Decisions Foundation decision aid (DA)–Hormone Therapy: When the PSA Rises After Prostate Cancer Treatment–on decisions about initiating ADT for BCR and on validated measures of knowledge, anxiety and decisional conflict.
Our specific aims and associated hypotheses are:
Specific aim 1: To measure the impact of the DA on validated measures of patients’ prostate cancer-specific anxiety (Memorial Anxiety Scale for Prostate Cancer [MAX-PC]) and general anxiety (State-Trait Anxiety Inventory-State [STAI-S]). We hypothesize that the use of the DA will lower anxiety, particularly cancer-specific anxiety, as compared with levels pre-exposure to the DA and in those not assigned to receive the DA.
Specific aim 2: To measure the impact of the DA on patients’ level of decisional conflict with an established measure, the Decisional Conflict Scale (DCS). We hypothesize that use of the DA will lower decisional conflict compared with levels pre-exposure to the DA and in those not assigned to receive the DA.
Specific aim 3: To measure the impact of the DA on knowledge about PCA, BCR and ADT. We hypothesize that use of the DA will increase patient knowledge of BCR, PCA and ADT compared with pre-exposure to the DA and in those not assigned to receive the DA.
Specific aim 4: To measure the impact of the DA on the patient’s projected and actual likelihood of initiating ADT immediately or waiting. Based on support for hypotheses 1-3 and our previous findings, we hypothesize that men randomized to the DA will be less likely to decide to start ADT immediately, compared with those randomized to SOC.
Results supporting these hypotheses about the impact of the DA will establish the need for a larger trial to test the effects of the DA and other interventions on long-term outcomes associated with decisions about treating BCR with ADT.
