Multidisciplinary Quality of Life Intervention for Men with Biochemical Recurrence of Prostate Cancer

Transcription

1 Multidisciplinary Quality of Life Intervention for Men with Biochemical Recurrence of Prostate Cancer Steven C. Ames, PhD, ABPP Division of Hematology & Oncology

2 Investigative Team Winston W. Tan, MD Mayo Clinic Gretchen E. Ames, PhD, ABPP Mayo Clinic Ronald L. Stone, RD, LD, CNSD Mayo Clinic Thomas D. Rizzo, Jr., MD Mayo Clinic Christopher R. Williams, MD University of Florida Chudley E. Werch, PhD University of Florida Julia E. Crook, PhD Mayo Clinic Matthew M. Clark, PhD Mayo Clinic Teresa R. Rummans, MD Mayo Clinic

3 Acknowledgements Funding for this project was provided by an Issues of Cancer Survivorship grant from the Lance Armstrong Foundation. This study would not have been possible without the invaluable assistance of: - Edgar Covil - Judy Olmos, RN, MSN, CCRP

4 Background: Prevalence of Prostate Cancer Most prevalent malignancy in men and second leading cause of cancer related death worldwide. 192,280 new cases (2009 estimate) 27,360 deaths (2009 estimate)

5 Background: Treatment & Biochemical Recurrence Approximately 2/3 of new cases undergo local treatment (i.e., radical prostatectomy or radiation). Of these, 30% - 40% experience biochemical recurrence (i.e., 38 50k/yr)

6 Background: Biochemical Recurrence Biochemical recurrence: rising PSA without overt distant disease. Although biochemical recurrence is accepted as an endpoint for defining treatment outcome, its clinical significance is unclear. Overt metastatic disease many not become evident for many years.

7 Background: Biochemical Recurrence and QOL Because overt disease secondary to biochemical recurrence is protracted, QOL is of particular importance to this population of cancer survivors. Despite the importance of this issue, the impact of biochemical recurrence has been understudied.

8 Preliminary Research Psychological needs of men (n=28) with biochemical recurrence evaluated using mixed qualitative-quantitative quantitative approach. HRQOL (prostate specific) prostate cancer-related related physical symptoms Men s s interests: medical education about management of prostate cancer (treatment-related related side effects, recent advances) stress and negative mood (anger, anxiety) management techniques nutrition physical activity Ames et al., 2008, 26(2), J Psychosoc Onc.

9 Ames et al., 2008, 26(2), J Psychosoc Onc.

10 Ames et al., 2008, 26(2), J Psychosoc Onc.

11 Aim & Hypothesis Aim: : Evaluate the feasibility, acceptability, and estimate the effect size of our newly developed multidisciplinary QOL intervention for men with biochemical recurrence of prostate cancer. Hypothesis: : Our multidisciplinary intervention would be feasible to deliver, acceptable to men, and would favorably impact several key psychological factors including health-related and general quality of life, prostate cancer specific anxiety, mood, and perceived stress in this population of cancer survivors.

12 Methods: Participants (N=57)( Inclusion criteria: > 18 years of age Expected survival > 1 year Prostate CA with PSA recurrence post- surgery or radiation without clinical or x-ray x evidence of metastases Free of other forms of cancer within < 5 years (except non-melanoma skin CA) Mini-Mental Mental Status Examination score > 24

13 Methods: Participants (N=57)( Exclusion criteria: Received psychological/psychosocial treatment intended to address emotional adjustment/coping with prostate cancer < 3 months Alcohol or (non-nicotine) nicotine) drug dependence in < 3 months Active untreated thought disorder Current severe level of clinical depression (BDI-II II score > 29) or current suicidal intent

14 Methods: Procedure Participants recruited during f/u visit with urologist or medical oncologist at two large academic medical centers in NE FL, via ACS mailing, or via print advertisement. Randomized two-group design. Participants paid $115 for completion of assessments.

15 Schedule of Baseline, Treatment, & Follow-up Assessments Week Scheduled visit X X X X X X X X X X X Screen/baseline X Randomization X Treatment X X Follow-up Assessment X X

16 Methods: Treatment Conditions Wait List Control (WLC) Participants did not receive any form of QOL intervention. Offered MQOL following completion of study. Multidisciplinary QOL Intervention (MQOL) Eight, one-hour, structured treatment sessions in group setting. Manualized & facilitated by multidisciplinary team of health care providers.

17 Methods: Measures Demographic data Treatment feasibility Participant retention and treatment compliance Treatment acceptability Participant ratings of helpfulness of treatment Quality of Life Functional Assessment of Cancer Therapy-Prostate (FACT-P) Medical Outcomes Study 36-item Short Form Survey (SF-36) Anxiety Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Stress Perceived Stress Scale-10 (PSS) Mood Profile of Mood States-Brief (POMS-B)

18 Methods: Statistical Analysis Baseline demographics of participants from each treatment condition were summarized and compared using the Wilcoxon rank sum test for continuous variables and Fisher s s exact test for categorical variables. With the exception of the SF-36, all measures were re-scaled such that they have a range of 0 to 100, with higher values indicating a more favorable outcome. For all measures fitted means at each time point were calculated using linear mixed effects models.

19 Baseline Participant Characteristics Characteristic WLC (N=27) MQOL (N=30) Age, median (IQR) Race, n (%) White Black Marital Status, n (%) Married Widowed Divorced Unknown Employment Full-Time Part-Time Retired 76 (71-81) 22 (81%) 5 (19%) 23 (85%) 1 (4%) 3 (11%) 0 (0%) 2 (7%) 0 (0%) 25 (93%) 75 (70-80) 29 (97%) 1 (3%) 28 (93%) 1 (3%) 0 (0%) 1 (3%) 1 (3%) 3 (10%) 26 (86%)

20 Results: Feasibility The study methodology was feasible as indicated by a favorable participant retention (100% were retained through end of treatment) and compliance with the MQOL intervention (97% attended 6 or more treatment sessions).

21 Results: Acceptability Participants rated the MQOL intervention as highly acceptable; on a 5-point 5 scale, 80% rated helpfulness as 4 ( very( much ) ) or 5 ( extremely ), while 16% rated helpfulness as 3 ( moderately ). Suggestions solicited from participants on ways to improve treatment included: inclusion of longer treatment sessions increased length of time allocated to group discussion inviting participant s s spouses to attend select sessions

22 Results: QOL & Psych. Factors

23 Discussion This is the first published investigation pilot testing a behaviorally-based based tailored multidisciplinary QOL intervention for men who have experienced biochemical recurrence of prostate cancer. Treatment approach (MQOL) Feasible Acceptable May reduce prostate cancer specific anxiety and enhance disease-specific specific QOL and mental health aspects of general, non-disease specific, QOL.

24 Discussion Lack of durability of the intervention, given how enthusiastic our participants were about the treatment and anecdotal comments that were made about it s s perceived helpfulness. Degree of interest men with biochemical recurrence of prostate cancer expressed in receiving the intervention and conversely the difficulty encountered with engaging health care providers.

25 Discussion: Limitations Efficacy results are limited by the small sample size and relatively homogeneous sample, and must be viewed as preliminary. Participant payment may have introduced an unintentional bias on acceptability.

26 Discussion: Future Directions Development a larger randomized trial to examine the efficacy of the intervention. Explore potential cognitive and behavioral mediators: Engagement in active behavioral coping strategies such as planning, seeking social support, physical activity, and healthy diet. Active cognitive coping strategies such as acceptance, reframing, positive attributional style, and optimism. Explore modifications that were suggested by study participants: Extending the duration or number of treatment sessions Increasing the length of time allocated to group discussion Inclusion of spouses at selected sessions

27 Questions?