Managing Uncertainty in Advanced or Recurrent Prostate Cancer
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Summary of Findings
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Summary of Findings Managing Uncertainty in Advanced and Recurrent Prostate Cancer # NR03782. 1998 to 2003. The major aim of the study was to examine the effects of an uncertainty management intervention delivered by a nurse via telephone using two different structures for delivery--directly to the patient (treatment direct) or directly to the patient and to a primary support person (PSP) (treatment supplemented) in comparison to usual care. The final sample for the study was 271 men of which155 were categorized as advanced and 116 were categorized as recurrent. Men were blocked on disease status either recurrent or advanced and randomly assigned from the block to one of 3 treatment conditions either treatment direct (TD) where the man received the telephone –delivered intervention, or treatment supplemented (TS) where the man and his primary support person (PSP) each received the intervention or to a control condition (C) of usual care. The enrollment distribution for Caucasian men was 50 in TD, 54 in TS and 51 in C. for the African-American men; the enrollment distribution was 44 in TD, 37 in TS and 35 in C. Of the men with advanced disease, 52 were in the TD group, 57 were in the TS group- and 46 were in the control group. Of the men with recurrent disease, 42 were in the TD group, 34 were in the TS group and 40 were in the control group and this is further broken down by ethnicity. The intervention was delivered weekly by telephone for eight weeks. Each intervention call was summarized on to a relational database. Following the intervention we were able to identify the major concerns of the men in the treatment groups and the major interventions used to help the men with their concerns. The most common concerns of the men were information about possible treatments, non-traditional treatments and expectations about treatments. Although treatments are very limited for men with recurrent or advanced disease, treatment issues were highly important. This was followed with concerns about the side effects from hormone therapy including hot flashes, sexual functioning and bone pain along with fluctuating PSA levels. The most frequent category of intervention to help the men was providing information to address the specific concern. This was followed in frequency by the strategies of providing and explaining resources, activating resources, and promoting awareness of treatment options. These strategies along with the strategies of validating self care behaviors and promoting assertive behavior comprise the most frequently used interventions to address the problems and concerns expressed by the men who received the intervention in this study. Analysis: To address whether there were benefits from the intervention, repeated measures MANOVAs were conducted for uncertainty management strategies (cognitive reframing, problem solving, cancer knowledge, and patient-provider communication) and for intensity of symptoms (back or pelvic pain, not being able to have an erection, breast enlargement, hot flashes, hair loss, weight gain, constipation and change in body fat) emotional state (depression, anxiety, hostility, fatigue, vigor, and confusion) and CARES scale (medical, physical, psychosocial, sexual, marital, and hormone related problems) looking at treatment group, ethnic group, and treatment by ethnic interaction effects. When the MANOVA revealed a significant difference, follow-up repeated measures analyses with planned contrasts to test the hypotheses were performed for the individual variables. To look at patterns of change over time, planned contrasts between baseline (T1), 4 months post baseline which was 2 months after completion of the intervention (T2), and seven months post baseline (T3) were constructed in order to test for both initial and delayed impact of the intervention. Contrasts for these time differences were also constructed and tested for within ethnic groups to see if differences existed for only one ethnic group. Tests of Intervention Effect: The MANOVA for uncertainty management variables indicated that there were significant differences over time among the groups. Follow-up analyses revealed that three of the strategies for managing uncertainty, cognitive reframing, and cancer knowledge and patient-provider communication were significantly different between the groups. For cognitive reframing, preplanned contrasts showed that there was a significant effect for the TS group of Caucasian men with recurrence versus the recurrence control group from time 2 to time 3. This recurrence treatment group had an increase in cognitive reframing while the control group declined from time 2-3, however at time 1-2 this effect was not evident. For cancer knowledge there was a significant main effect for intervention groups. Preplanned contrast showed that there was a significant difference over time for the all men in both the advanced TD and TS group versus advanced control from time 1 to time 2 and for all men in both the recurrent TD and TS groups versus recurrent control from time 1 to time 2. For patient provider communication, preplanned contrasts showed that there were significant findings for three of the doctor-patient communication items. For “How much do you tell the doctor”, all men in both the advanced TD and TS groups reported higher levels of communication time 1 to time 2 then did their control group. There were no differences for recurrence versus control. For “How much do you tell the nurse”, there were significant interactions with ethnicity where the recurrent Caucasian TD group shared more with the nurse then did the recurrent Caucasian control group from time 2 to time 3. For “How much do you help in planning treatment”, there were significant interactions with ethnicity. The advanced Caucasian men in the advanced disease TS group had greater participation in their treatment plan from time 1 to time 3. Similar findings were reported for the recurrent TS group. These men also had greater participation in their treatment plan from time 2-3 than did the recurrent control group. The MANOVA for symptoms was significant with a difference over time among the groups. Follow-up analyses indicated that there were differences in symptom severity for the symptoms of back pain, constipation, inability of have an erection, breast enlargement, change in body fat, hot flashes, hair loss and weight gain. Most of these differences were for time 2 to time 3, which indicated that these changes take a few months to emerge after the intervention. Both recurrent and advanced subjects receiving the intervention reported changes in symptoms and usually there was an interaction with ethnicity. For African-American men in the treatment groups, recurrent African American men in the TS group reported significantly less severe back pain than men in the control group from time 2 to time 3,. This same group reported significantly less constipation from time 2-time 3. African American men with recurrence in both the TD and TS groups reported decrease in change in body fat from time 2 to time 3 was reported as compared with their control. For Caucasian men, men in the recurrence Caucasian TS group reported an improvement in their ability to have an erection as compared with the recurrence Caucasian control group from time 2 to time 3. Differences for the TS group of Caucasian men with advanced disease were reported for significant changes in the tendency toward breast enlargement as compared with the advanced Caucasian control from time 1 to time 2. A decrease in the severity of the loss of hair was reported by the advanced Caucasian TD group as compared with their control from time 2 to time 3. All treatment groups with recurrence, both TD and TS, reported a decrease in the intensity of hot flashes and a reduction in the severity of weight gain from time 2 to time 3 as compared with the recurrence control groups. Emotional State The MANOVA for the Profile of Mood States was not significant. However, since this was the first intervention study of men with recurrent/advanced disease, we believed that it was important to look at the contrasts across subscales. Further analysis of the specific subscales indicated that the depression and fatigue subscales showed treatment effects. For depression, from time 2 – time 3, the recurrent African American men in the TS cell significantly decreased in depression as compared to their controls. For fatigue, men with recurrent disease in both TS and TD groups significantly reduced their level of fatigue from time 2 to time 3 as compared with recurrent control groups. Discussion Since this was the first psycho-educational intervention offered to men with recurrent and advanced disease the gains noted in cancer knowledge, doctor-patient communication and symptom management indicates the usefulness of the intervention. It also supports that men with more severe disease can still have an improved quality of life if an intervention targets their concern.
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