Managing Uncertainty in Stage B Prostate Cancer

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Summary of Findings Managing Uncertainty in Stage B Prostate Cancer. (1-R01-NR03782) P.I. Merle Mishel, Co-P.I. Barbara Germino. September, 1993-March, 1998. The objective of this study was to test the efficacy of an individualized uncertainty management intervention delivered by telephone to Caucasian and African-American men with localized prostate cancer and directed at managing the uncertainties of their disease and treatment. One hundred and thirty-four Caucasian men and 105 African-American men were assigned randomly to one of two approaches to delivering the intervention or to a control condition. The intervention groups were defined as the man receiving the intervention (treatment direct-TD) or the man and his primary support person receiving the intervention (treatment supplemented-TS). Men entered the study immediately after surgical treatment or during the first three weeks of radiation therapy. Trained nurses delivered the intervention through weekly phone calls for eight weeks. Measurement occurred at three points in time: at entry into the study (baseline; T1) prior to delivery of the 8 week intervention, 4 months post baseline or 2months post intervention (T3), and 7 months post baseline (T3). The average age of the men in the study was 64 (SD=6.9). The study participants were divided almost evenly by ethnicity, with 56% Caucasian and 44% African-American. Most of the men were married. Using the tumor-lymph node metastases (TNM) staging classification system, 8% of the men has stage T1 tumors, 61 % of the men had stage T2 tumors, 27 % had stage T3 tumors and 4 % did not have staging information available. Most patients were treated with surgery, with 56% undergoing radical prostatectomy, 23 % undergoing nerve-sparing surgery, and 21 % receiving radiation. A comparison of the intervention and control groups indicated that they differed significantly on marital status, tumor stage, and the number of health problems. Since all men in the study were required to enroll a family member, the differences in marital status would not bias the study. With regard to tumor stage, since the men in the control group had lower tumor stage then the intervention groups this would only make it more difficult to find a significant intervention effect. The one difference that could bias the intervention was the number of health problems; therefore we used health problems as a covariate in all analyses. Findings: Using the data from the intervention data base, we identified the most frequent problems/ concerns expressed by the men whop received the intervention. Four problems occurred most often for both Caucasian and African-American men. The four problems, in order of descending frequency, were leaking urine, erection problems, communication with health care providers and general treatment side effects. Analysis We conducted repeated-measures multivariate analysis of variance. When MANOVA revealed a significant difference, follow-up repeated measures analysis with planned contrasts to test the hypotheses were performed for individual variables. Only the results for individual variables are reported here. Preplanned contrast showed that there was a significant change with improvement for the all men in the treatment supplemented group from baseline to time 2 in cognitive reframing (which measures the ability to have a positive view of the situation). The control group declined on this measure from baseline to T2 but by time 3 all groups were similar on this variable. The same pattern for both treatment groups was found for problem solving with improvement from baseline to 4 months post baseline but no difference from control subjects by Time 3. In the analysis for the effect of the intervention on management of treatment side effects, there was a significant decrease in the number of symptoms for all intervention groups Caucasian men in the treatment supplements (TS) group from baseline to T2 as compared with the control group, but there was no significant difference between the groups from 4-7 months. However, for African-American men in the intervention, the difference between them and the controls in mean number of symptoms was found from 4-7 months. According to specific items referring to symptoms, men in the intervention groups showed significant improvement in control over urine flow between baseline and 4 months. Improvement continued over time but the differences in groups ceased to be significant. In satisfaction with sexual functioning, African-American men in the treatment supplemented group improved over the control again from baseline to 4 months post baseline. The improvement on this outcome did not continue to seven months. Since this was one of the first intervention studies with men with prostate cancer and the first to include a significant number of African-American men, the ability to report early improvement on a number of outcomes is meaningful. It does indicate that more is needed to maintain these early improvements in both cognitive state and symptom management.