Cancer Control Research
5R01CA095662-05
Sanda, Martin G.
SURVIVOR QOL/SPOUSE SATISFACTION AFTER PROSTATE THERAPY
Abstract
DESCRIPTION (provided by applicant): Background: Health related quality of life (HRQOL) is
a pivotal concern for early stage prostate cancer survivors and their spouses.
Recent developments, including the emergence of brachytherapy (BT), the
development of 3-D conformal radiotherapy (3D-ERT), the increased use of
adjuvant hormonal therapy, and the observation that radical prostatectomy (RP)
outcomes may differ between practitioners, fuel a need to re-evaluate HRQOL
outcomes in this context. HRQOL following BT, 3D-ERT, and RP have not been
characterized with an instrument validated to detect effects of each of these
interventions. Moreover, patient or provider determinants of patient HRQOL,
patient satisfaction, and spouse satisfaction remain uncharacterized. Because
prostate cancer survivors and experts determined that existing HRQOL
instruments lacked key items for concurrently evaluating HRQOL effects of BT,
ERT, and RP, we developed and validated the Expanded Prostate Cancer Index
Composite (EPIC) instrument using a cohort that equally represented each of
these 3 interventions. Factor analysis revealed 2 new HRQOL domains
(urinary-irritative and hormonal) complementing the 3 function domains of
UCLA-PCI (urinary-incontinence, bowel, sexual). The 5 HRQOL domains measured by
EPIC showed satisfactory internal consistency, reliability, and external
validity. Cross-sectional HRQOL comparison among 1014 BT, 3D-ERT, or RP
survivors and controls showed that each EPIC HRQOL domain was adversely
affected by at least one of the therapies. EPIC HRQOL domain scores associated
significantly with patient satisfaction and were sensitive to baseline factors
such as age, cancer severity, and prostate size. We hypothesize that patient
and provider characteristics affect HRQOL changes after brachytherapy, external
radiation, or prostatectomy, and that these interventions have different HRQOL
effects, which impact long-term patient and spouse satisfaction. The proposed
observational study has the following Specific Aims: 1) To assess baseline
determinants, including provider characteristics, of long-term HRQOL after BT,
3D-ERT, or RP; 2) To characterize baseline determinants of patient and spouse
satisfaction with intervention process and outcome; and 3) To evaluate effects
of therapy choice on HRQOL outcome and satisfaction.
Experimental Design: A prospective, observational, multi-institutional study
will be performed at 5 institutions with pre-existing, multi-disciplinary
expertise in BT, 3D-ERT, and RP. Patients with early stage prostate cancer
electing to undergo BT, 3D-ERT, or RP as primary therapy will be eligible.
Baseline demographics, cancer severity measures, and provider characteristics
will be recorded, while HRQOL will be measured using the EPIC survey instrument
administered at baseline (pre-therapy); then at 2 months, 6 months, and yearly
after therapy for 3 years. The multidimensional SSS-10 instrument, administered
to survivors and their spouses or life partners, will measure satisfaction with
process and outcome. The principal endpoints will be changes in EPIC domain
summary scores from baseline to two years after therapy, and survivor
satisfaction as well as spouse satisfaction. For each procedure, HRQOL changes
over time and yearly satisfaction scores will be modeled by a mixed effects
model; baseline risk factors that affect change will be identified. The effects
of each therapy on change in HRQOL will be compared after controlling for risk
factors identified in the previous step. The findings from this prospective,
observational study will provide benchmarks to guide outcomes expectations and
to facilitate evidence-based decisions regarding therapy.
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