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Quality of Life in Bladder
Cancer: Moving Toward
Interventions
David M. Latini, PhD
Baylor College of Medicine
TT5 – August 2010

Acknowledgements
 Seth Lerner, MD
 Gilad Amiel, MD
 John Chen, MD, PhD
 Heather Honoré Goltz, PhD, LMSW
 Marc Kowalkowski, BS
 Tae Hart, PhD (Ryerson)
 Leslie Schover, PhD (MDACC)
Project supported by funding from the Scott Department of Urology, Baylor
College of Medicine and resources provided by the Houston VA Center of
Excellence in HSR&D

Study 1 – Quantitative study
 135 patients from VA/BCM/Web interviewed
 Measures
 EORTC
 QLQ-C30 (general QOL)
 BLM-30 (MIBC QOL)
 BLS-24 (NMIBC QOL)
 Illness Intrusiveness Rating Scale
 Brief Symptom Inventory-18
 CaPSURE Fear of Recurrence
 Impact of Events Scale
 Partner Communication
 Social Constraint
 Social Support
• Inclusion criteria
• Diagnosed ≤ 4 years
• Any stage disease
• No radiation treatment
• Speak/understand English

Quantitative study participants
NMI (n=117) MI (n=18) p
Age 64.6 (9.5) 57.7 (8.4) <0.01
Gender
Male 85 (72.7%) 9 (50.0%) 0.06
Female 32 (27.3%) 9 (50.0%)
Education
High school graduate 18 (15.4%) 3 (16.7%) 0.85
Some college 43 (36.8%) 7 (38.9%)
BA/BS 32 (27.3%) 6 (33.3%)
Postgraduate degree 24 (20.5%) 2 (11.1%)
Ethnicity
White 110 (94.0%) 18 (100.0%) 0.59
Non-white 7 (6.0%) 0
Relationship Status
Married 87 (74.4%) 12 (66.7%) 0.57
Single and never married 3 (2.6%) 0
Separated or divorced 17 (14.5%) 5 (27.8%)
Widowed 10 (8.5%) 1 (5.5%)

EORTC QLQ C-30 – QOL scales
0
10
20
30
40
50
60
70
80
90
100
PF RF** EF** CF SF** GL**
NMIBC
MIBC
60-69
I/II
III/IV
Non-Ca
Better QOL
** p < .01 PF = Physical Fx, RF = Role Fx, EF = Emotional Fx, CF = Cognitive Fx, SF = Social Fx,
GL = Global health status

EORTC QLQ C-30 – Sx scales
0
5
10
15
20
25
30
35
40
45
50
FA** NV** PA** DY SL** AP* CO** DI** FI**
NMIBC
MIBC
60-69
I/II
III/IV
Non-Ca
* p < .05, ** p < .01 FA = Fatigue, NV = Nausea/vomiting, PA = Pain, DY = Dyspnea, SL = Insomnia, AP = Appetite,
CO = Constipation, DI = Diarrhea, FI = Financial difficulties
More Sx

Psychological Distress – BSI-18
0
10
20
30
40
50
60
70
80
90
100
BSI-Total BSI-Som BSI-Dep BSI-Anx
NMIBC
MIBC
All differences p < 0.01
More distress
T-scores → Mean = 50, SD = 10

Psychological Distress – FOR
0
10
20
30
40
50
60
70
FOR* Future
Perspective*
Illness
Intrusiveness**
53.8
65.2
NMIBC
MIBC
* p < .05, ** p < .01
More distress/life disruption
N.B. – CaPSURE means → pre-tx FOR = 36, post-tx FOR = 20-23

Urinary and GI Sx
1
2
3
4
Urinary Sx Abdom Bloating** Flatulence**
NMIBC MIBC
Worse
Fx
Better
Fx
* p < .05, ** p < .01

Urinary sx
0
10
20
30
40
50
Freq -
Day
Freq -
Night
Urgency Sleep
Int.
Isolation Leakage Pain/
burning
NMIBC MIBC
Percent of respondents reporting “Quite a bit/Very much”

Sexual Sx
1
2
3
4
Interested in sex? Sexually active? Sex enjoyable?
NMIBC
MIBC
No significant differences
Better Fx

Sexual Sx
1
2
3
4
ED* Ejac
Prob**
Dry Vagina Uncomf
w/ sex*
Contam
NMIBC
MIBC
* p < .05, ** p < .01
Better Fx

Implications
 MIBC generally report worse QOL, more sx than
NMIBC
 Both groups report problems with urinary and sexual
sx for which patient education is available
 FOR substantially higher than PCa survivors
 Group means may mask specific sub-groups having
difficulties that could be addressed with tailored
interventions

Study 2 – Qualitative study
 Why collect qualitative data?
 Qualitative data lets you ask detailed questions about the
person’s experience.
 Raises issues not covered in validated questionnaires.
 Semi-structured, so responses to one question may lead to
other questions, etc.
 Confirms quantitative data.

Qualitative Study – Methods 1
• VA participants recruited from list generated by
the Tumor Registry.
• BCM patients recruited from Urology patient list.
• Inclusion criteria
• Diagnosed ≤ 4 years
• Nonmuscle-invasive bladder cancer
• No radiation treatment
• Speak/understand English

Qualitative Study – Methods 2
• Participants recruited via opt-out letter
• Those who returned letter were contacted and screened. (“yes”
response only)
• Those who did not return letter within 10 days were contacted for
recruitment and screening
• Average interview ~1 hour and 10 minutes
• Interview guide contains verbal consent information and eight
sections
• Diagnosis,
• Treatment,
• Monitoring,
• Symptoms and management,
• Relationships and sexuality, and
• Patient navigation

n (%)
Gender
Male 15 (88.2%)
Race/Ethnicity
White 13 (76.5%)
Black or African American 4 (23.5%)
Education
HSD or less 5 (29.4%)
Some college 7 (41.2%)
Bachelor's degree 4 (23.5%)
Unknown 1 (5.9%)
Marital Status
Married 12 (70.6%)
Single, never married 3 (17.6%)
Separated/Divorced 1 (5.9%)
Widowed 1 (5.9%)
Qualitative Participants

Cancer Navigation Models
• The Harlem Patient Navigation
Program was established in 1990.
• Its purpose was “to address the
dramatic disparities in breast cancer
mortality among minority women in
the community” (Freeman, 2006).
• “…social position, economic status,
culture, and environment (are) critical
determinants of who develops and
survives cancer and of the quality of life
of cancer survivors” (Freeman, 2006).
• The poor and underserved are
disproportionately affected.
• The “Canadian” or “Psychosocial
Model” of cancer patient navigation
emphasizes:
• “Timely access to informational and
emotional support around the time
of cancer diagnosis is crucial in
helping patients adapt and prepare
for their journey in navigating the
health-care system” (Doll et al.,
2005).
• “Navigation should seek to address
patients’ informational, emotional,
and practical needs during the
cancer journey” (Doll et al., 2005).
Harlem
(Access to Care)
Canadian
(Psychosocial Support)Hybrid

What model would you prefer?
• Most participants (n=15)
endorsed having a navigator or
“coach” as an aide during the
treatment and monitoring
process.
•13 VA participants endorsed
•2 BCM participant endorsed

Cross-sectional study plans
 Survey
 Increase MIBC to ~ 50 participants (need 33)
 Comparisons between NMIBC/MIBC, predictors of distress,
sexual dysfx, predictors of adherence, etc.
 Qualitative study
 Increase to 40 participants (need 17 BCM, 3 VA)
 Navigation paper, disease-specific literacy, women’s issues in
BlCa, etc.

Implications
 Navigators/sx coaches should address both access to
care and psychosocial support
 Community resources may be an important need for
some survivors
 Literacy may be important for some groups
 Be mindful of ongoing cost/feasibility issues

Interventions – what do we need?
 Multi-focal interventions tailored to patient/survivor
needs
 Decision-Making Tools
 Navigation
 Sx Management
 Distress Management
 Community Resources
 Low-literacy Patient Education Materials

Navigation intervention
 Develop and test a bladder cancer navigation
program tailored to each survivor’s needs
 Information about and access to services
 Psychosocial support
 Educational materials at the right literacy level
 Support adherence to monitoring
 Delivery by phone and US mail
 Different strategies for NMIBC vs. MIBC

Longitudinal QOL study
 Population-based sample
 Describe changes in QOL over time (within-
person as well as between persons)
 Symptoms and management strategies
 Predictors of QOL trajectories
 Inform navigation intervention or separate
symptom management intervention based on
ACS PCa low-health-literacy patient education
program

Survivorship care plan RCT
 Care plans – good face validity but where’s the beef?
 Little research showing if/how they improve patient outcomes,
quality of care, process of care
 Survivorship Working Group developing bladder
cancer survivorship plan
 Pilot – early 2011
 RCT – mid 2011 – VA?

Distress in Veterans with cancer
 Many studies show some cancer patients and
survivors report depression, anxiety, etc.
 Veterans may be particularly vulnerable because of
previous traumatic experiences (in addition to
“normal” distress in older adults)
 NCCN guidelines – Distress Thermometer and
checklist
 May be necessary but not sufficient in Veterans

Distress in Veterans with cancer
 Q – how do we accurately measure distress in
Veterans with cancer (and what do we do once we
measure it!)
 Descriptive study at MEDVAMC and other medical
centers
 Descriptive, measurement, process of care
 Inform intervention to change VA process of care for
cancer patients and survivors

Summary
 NMIBC and MIBC have different but equally
important needs for survivorship care
 FOR and burden of disease may be a concern
 Urinary sx and some sexual sx should be addressed
 Navigation may be a way to address sx and other
concerns such as access to care and finances
 Longitudinal QOL needs to be studied

David M. Latini, PhD
Assistant Professor of Urology
Baylor College of Medicine
Chief, Design & Analysis Program,
VA HSR&D Center of Excellence (152)
2002 Holcombe Boulevard
Houston, TX 77030
(713) 794-8546 - VM
(713) 748-7359 – fax
david.latini@va.gov - email
latini@bcm.tmc.edu – alternate email

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