Improving Survivorship Care for LongTerm Colorectal Cancer Survivors:
Key Findings of a 5-Year
5 Year Study
Mark C. Hornbrook,, PhD
The Center for Health Research
Kaiser Permanente Northwest
AcademyHealth Annual Research Meeting
June 27, 2009
Chicago, Illinois
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
How Can Research Improve
p
Cancer
Survivorship Care?
(IOM 2006)
 By describing:
 How to deliver follow
follow-up
up care
care, to whom
 Late effects, symptoms, functional impairments
 By
B designing and eevaluating:
al ating
 Interventions to improve the quality of life of cancer
survivors,
i
their
th i families,
f ili andd caregivers
i
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Colorectal Cancer in the U.S.
 Third
Thi d mostt common cancer
 Third leadingg cause of cancer death
 New cases in 2008:
 108,070
108 070 (colon)
 40,740 (rectal)
 5+ Yr survivorship: 57–68%
57 68%
 1.1 M Survivors (and growing)
(Sources: ACS, 2008: Colorectal Cancer Facts & Figures 2008-2010; SEER.cancer.gov)
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Surgical Options After Tumor Resection for CRC
 Anastamosis: bowel sections reconnected
 Ostomy: bowel is brought out of abdominal wall
 “…concern about a colostomy frequently
supersedes all other considerations of the
patient.”
(Cohen et al. 1997)
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Funding
 National Cancer Institute
 R01 CA106912: HR-QOL in Colorectal Cancer Survivors with Stomas, Robert
Krouse, MD, PI
 R01 CA106912: Minority Supplement,
Supplement Michelle Ramirez,
Ramirez PhD
 R21 CA129887: Intestinal Ostomies and Informal Caregiving for Colorectal
Cancer Survivors, Carmit McMullen, PhD, PI
 R01 Renewal (R01 CA106912-04A1 ): HR-QOL in colorectal Cancer Survivors
with Stomas,
Stomas Robert Krouse
Krouse, MD
MD, PI,
PI Lisa Herrinton,
Herrinton PhD,
PhD Co-PI
Co PI
 CA023074: Arizona Cancer Center Support Grant
 Sun Capital Foundation (unrestricted donation)
 The Clayman Foundation (unrestricted donation to purchase
SF-36v2 software)
 Resources and facilities were provided at the Southern Arizona
VA Health Care System,
System Tucson,
Tucson AZ
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Multidisciplinary, Multi-site Team

University of Arizona / Veterans
Affairs






Arizona State University


Robert M. Krouse, MD (Surgical
Oncology)
Stephen Joel Coons
Coons, PhD
(Psychometrics)
Sylvan Green, MD (deceased)
(Biostatistics)
Jane Mohler, MPH, PhD (Health Services
Research)
Christopher Wendel, MS, PhC (Statistics)
Carol Baldwin,
Baldwin RN,
RN PhD (Nursing
Research)
City of Hope

Marcia Grant,, RN,, DNSc ((Nursingg
Research)
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH

Kaiser Permanente Northern
California



Kaiser Permanente Northwest



Mark C. Hornbrook, PhD (Economics)
Carmit McMullen, PhD (Medical
Anthropology)
Kaiser Permanente Hawaii


Andrea Altschuler, PhD (Sociology)
Lisa Herrinton, PhD (Epidemiology)
Eric Matayoshi, MD (Surgery)
University of the Sciences in
Philadelphia

Michelle Ramirez, PhD (Medical
Anthropology)
HRQOL in Colorectal Cancer Survivors with
Stomas
Surveys to long-term CRC survivors at
KPNW,, KPNC,, KPH included mCOHQOL & SF36:
Ostomy
Anastamosis
Overall
284 (54%)
395 (51%)
679 (52%)
Medical records data
Focus groups and in-depth interviews.
Mohler, Curr Med Res Opinion, 2008.
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Quality of Life Domains
Physical
Well Being
Psychological
Well Being
QOL
Social
Well Being
Ferrell, et al, 1991
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Spiritual
Well Being
Survivorship Care Issues
 What are the unique challenges faced by CRC
survivors with ostomies?
 Do HRQOL effects of surgical reconstruction
differ by gender?
 What complications do survivors experience
given different surgical reconstructions?
 What are the determinants of HRQOL among
CRC survivors?
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Challenges of Living with an Ostomy
 Survivors in KPNW, KPNC, and KPH (N=178) wrote
about their “greatest challenge” in living with an
ostomy.
ostomy
 McMullen et. al, J Supp Oncol, 2008
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Patient-reported Challenges Suggest Survivorship
Care Needs for Ostomy Patients
 Provide education, skill building, and emotional support
 Continued production and accessibility to good, safe, and
economical
i l ostomy
t
equipment
i
t
 Consider co-morbidities’ impact on ostomy
function/management
 Raise awareness of ostomies among health-care
professionals
 Patients
P i
hhave persistent
i
psychosocial
h
i l adjustment
dj
problems well beyond the post-operative period
 McMullen,, J Supp
pp Oncol,, 2008
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Partners’ Support
pp has Considerable Impact
p
on Womens’ Adjustment to Ostomies
 Descriptions of husbands’ support (positive/negative)
strongly linked to women’s HRQOL (high/low)
 Counseling regarding the potential impact of
husbands’ support could become a standard element
off pre-surgical
i l preparation
i ffor ffemale
l CRC patients
i
facing ostomy surgeries
 Altschuler et al
al., 2008
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Survivorship Care Issues
 What are the unique challenges faced by CRC
survivors with ostomies?
 Do HRQOL effects of surgical reconstruction
differ by gender?
 What complications do survivors experience
given different surgical reconstructions?
 What are the determinants of HRQOL among
CRC survivors?
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Stomas Have More of an Effect on Women
 Women report more fatigue
 Women report more sleep problems
 Sleep disturbances associated with fear of or actual
leakage
 Baldwin et al., in press
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Stomas Have More of an Effect on Women
 Response rate was 52% for all sites combined
 283 respondents with ostomy
 392 respondents without ostomy
 m-COH-QOL Cronbach’s alpha for ostomates 0.94, nonostomates 0.93
 Findings were similar when analysis was restricted to rectal
cancer survivors
i
 Men with ostomy felt more depressed following their surgery
(39% vs. 20%; OR 2.0) and had greater suicidal ideation (4.9%
vs. 2.6%;
2 6% OR 2.0);
2 0) th
these results
lt were more pronouncedd ffor
women (44% vs. 23%, OR 2.9; 8.6% vs. 1.9%, OR 5.3)
 Krouse et al., in press
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
COH-QOL-Ostomy Scaled Item Scores*
Psychological Domain
Females
Males
Ostomy
(n=168)
Mean (SD)
Control
(n=233)
Mean (SD)
Adjusted
difference†
P-value†
Ostomy
(n=118)
Mean (SD)
Control
(n=162)
Mean (SD)
Adjusted
difference†
P-value†
Enjoyment
7.1 (2.9)
7.6 (2.5)
-.08
0.80
6.7 (2.8)
8.0 (2.3)
-1.36§
<0.001
Control
7.5 (2.7)
Appearance
6.8 (2.6)
7.1 (2.3)
-.03
0.91
5.5 (3.0)
6.7 (2.5)
-1.27§
0.003
Anxiety
7.6 (2.7)
7.0 (2.7)
.77
0.02
6.5 (2.8)
7.5 (2.5)
-1.09§
0.006
Depression
8.0 (2.6)
7.9 (2.4)
.50
0.08
7.0 (2.9)
8.3 (2.4)
-1.08§
0.007
Privacy
9.2 (2.0)
8.5 (2.8)
.67
0.03
9.0 (2.2)
9.1 (2.2)
.11
0.74
‡
7.3 (2.5)
.32
0.29
6.7 (3.0)
7.8 (2.3)
-1.47§
<0.001
‡
* Based
B
d on a response scale
l off 0 to
t 10,
10 with
ith higher
hi h scores reflecting
fl ti more positive
iti outcomes
t
† Adjusted for age, comorbidity score, income, work status, tumor site (rectum vs colon)
‡ Statistically significant after Bonferroni adjustment (adjusted alpha = .05/34 = .0014)
§ Exceeds Minimally Important Difference (empirical rule effect size)
Krouse,
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
JCO, in press
COH-QOL-Ostomy Scaled Item Scores*
Social Domain
Males
Females
P-value†
Ostomy
(n=118)
Mean
(SD)
Control
(n=162)
Mean (SD)
Adjusted
difference†
P-value†
-.84
0.005
8.0 (2.8)
8.9 (2.0)
-.97§
0.007
7.3 (2.7)
-.20
0.54
6.6 (3.1)
7.2 (2.8)
-1.09§
0.01
6.9 (3.3)
8.3 (2.8)
-1.06
1 06§
0 003
0.003
6.3 (3.6)
8.4 (2.9)
-1.67
1 6 §
0.001
0
001‡
Personal
Relationships
7.3 (3.4)
8.7 (2.4)
-.95§
0.005
7.7 (3.3)
9.3 (1.6)
-1.49§
<0.001‡
Isolation
8.3 (2.7)
9.0 (2.1)
-.30
0.27
7.8 (2.9)
9.3 (1.6)
-1.27§
<0.001‡
Recreational
Activities
6.1 (3.7)
7.5 (3.3)
-1.18§
0.004
6.1 (3.6)
8.2 (2.9)
-2.34§
<0.001‡
Social Activities
7.1 (3.3)
8.3 (2.7)
-.84
0.02
6.9 (3.5)
8.8 (2.3)
-1.66§
<0.001‡
Intimacy
5.0 (4.0)
7.6 (3.3)
-1.94§
<0.001‡
5.9 (3.9)
8.7 (2.6)
-2.72§
<0.001‡
Ostomy
(n=168)
Mean (SD)
Control
(n=233)
Mean (SD)
Adjusted
difference†
Financial
Burden
7.6 (3.0)
8.6 (2.2)
Family Distress
7.0 (3.0)
Travel
Challenges
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Krouse, JCO, in press
Survivorship Care Issues
 What are the unique challenges faced by CRC
survivors with ostomies?
 Do HRQOL effects of surgical reconstruction
differ by gender?
 What complications do survivors experience
given different surgical reconstructions?
 What are the determinants of HRQOL among
CRC survivors?
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Surgical
g
Complications
p
for Survivors with
Ostomies (N=679)
 Fistulas have significant, long-term effect on
HRQOL
 Early post-op complications do not signal longterm HRQOL deficits
 Patients with ostomy have approximately 50%
higher rates of surgical complications than
those with anastamosis
 Liu et al
al. (in press)
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Bowel Function and Dietaryy Adaptations
p
of
Patients with Ostomy vs. Anastamosis
 Results from self-reported survey data (N=681)
 Bowel function:
 Patients with ostomies report more trouble with gas (p=.02)
 Patients with anastamosis report more problem with
constipation (p=.001)
 Similar
Si il strategies
t t i tto attain
tt i bbowell control
t l (f
(foodd avoidance,
id
exercise, timing of eating)
 Grant et al.,, J Ca Ed,, 2007
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Dietaryy Adaptation
p
for Ostomyy vs.
Anastamosis Patients
 Comfort with diet
 <1 month: 41% vs. 49% (p=.03)
 >12 months/never: 18% vs. 22% (p=.03)
p of ppatients have long-term
g
 Both ggroups
difficulties with bowel function and dietary
adaptation
 Grant, J Ca Ed, 2007
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Survivorship Care Issues
 What are the unique challenges faced by CRC
survivors with ostomies?
 Do HRQOL effects of surgical reconstruction
differ by gender?
 What complications do survivors experience
given different surgical reconstructions?
 What are the determinants of HRQOL among
CRC survivors?
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Societal Preference-Weighted HRQOL
 SF-36v2 responses were scored with a societal
preference-weighting system to obtain an overall
societal-weighted HRQOL (SF-6D) score for each
respondent
 Mean
M
SF
SF-6D
6D score for
f ostomates was 00.69,
69 comparedd
to 0.73 for non-ostomates (p <.001) on a scale where
0=dead and 1=perfect health
 Multivariable linear regression: SF-6D score predicted
by clinical and socio-demographic variables
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
SF-6D Results
 The response rate was 52% (681/1310), with 640
participants having sufficient data for analysis
 Comorbidities, household income, self-reported
depression, age, prior hospital use, advanced stage at
diagnosis and late complications of surgery were
diagnosis,
independent predictors of SF-6D
ype of
o cancer
ca ce su
surgery—ostomy
ge y os o y vs.
s aanastamosis—
as a os s
 Type
was not significantly associated with SF-6D scores
 Hornbrook et al., submitted
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Summary
 Ostomates, especially women, have more HRQOL
problems
 20% of all patients have long-term problems adapting
their diet after CRC surgery
 Spousal/partner support plays an important part in
recovery of ostomy patients
 HRQOL issues should continue to be addressed by
practitioners throughout the CRC survivor’s life
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Strengths and Limitations
 Strengths




Community based setting with excellent long-term follow-up
Restriction to long-term CRC survivors
Comparison of ostomy to anastomosis
Large sample size
 Limitations
 Limited information able to obtain from electronic medical records (e.g.
exactt location
l ti off ttumor))
 No baseline function or HRQOL data
 No longitudinal data
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Future Directions
 Focus on caregivers: R21 (R21 CA129887): Intestinal Ostomies and
Informal Caregiving for Colorectal Cancer Survivors, Carmit McMullen,
PhD, PI
 Examine the entire population of rectal cancer survivors: R01 Renewal (R01
CA106912-04A1 ): HR-QOL in colorectal Cancer Survivors with Stomas,
Robert Krouse, MD, PI, Lisa Herrinton, PhD, Co-PI
 Pilot an intervention for ostomates: R21 (CA133337-01A1, resubmitted
11/12/08): HRQOL-enhancing
HRQOL enhancing Ostomy Self-management
Self management Intervention for
CRC Survivors, Robert Krouse, MD, PI, expected start date 7/1/09
 Study another under-examined cancer: R21 (CA522817, submitted
10/15/08; resubmission July 2009): Functional Impairment Among Longterm bladder Cancer
C
Survivors,
S
Carmit
C
McMullen, PhD, PI
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH
Selected Publications
Grant M, Krouse R, McMullen C, Hornbrook MC, Baldwin C, Herrinton L, Ramirez M, Altschuler A, Mohler MJ.
Dietary adjustments reported by colorectal cancer (CRC) survivors with permanent ostomies. Journal of
Cancer Education 2007; Supplement to 22(4):33.
McMullen CK, Hornbrook MC, Grant, M, Baldwin CM, Ramirez ML, Wendel CS, Mohler MJ, Altschuler A, Krouse
RS. The Greatest Challenges Reported by Long-Term Colorectal Cancer Survivors with Stomas. J Support
O l 2008 Apr;6(4):175-182.
Oncol
A 6(4) 175 182
Mohler MJ, Coons SJ, Hornbrook MC, Herrinton LJ, Wendel CS, Grant M, Krouse RS. The Health-Related
Quality of Life in Long-Term Colorectal Cancer Survivors Study: objectives, methods and patient sample.
Curr Med Res Opin 2008 Jul;24(7):2059-2070. NIHMS54243.
Lundy JJ, Coons SJ, Wendel CS, Hornbrook MC, Herrinton LJ, Grant M, Krouse RS. Exploring household income
as a predictor of psychological well-being
well being among long-term
long term colorectal cancer survivors.
survivors Quality of Life
Research 2009;18(2):157-161.
Altschuler A, Ramirez M, Grant M, Wendel CS, Hornbrook MC, Herrinton LJ, Krouse RS. The influence of
husbands’ or male partners’ support on women’s psychosocial adjustment to having an ostomy resulting
from colorectal cancer. Journal of Wound, Ostomy, and Continence Nursing 2009;May/June; 36(3):299-305.
Krouse RS
Krouse,
RS, Grant M
M, Herrinton LJ
LJ, Wendel CS
CS, Mohler MJ
MJ, Baldwin CM,
CM Coons SJ,
SJ Green SB,
SB McMullen C,
C
Matayoshi E, Hornbrook MC. Health-related Quality of Life Among Long-term Colorectal Cancer Survivors
with an Ostomy: Manifestations by Gender. J Clin Oncol (in press).
Baldwin, CM, Grant M, Wendel C, Hornbrook MC, Herrinton L, McMullen C, Krouse RS. Gender Differences in
Sleep Disruption and Fatigue Among Persons with Ostomies. J Clin Sleep Med (in press).
y
Liu L,, Herrinton,, LJ,, Grant M,, Wendel CS,, Mohler MJ,, Baldwin CM,, Coons SJ,, Green SB,, McMullen C,, Matayoshi
E, Hornbrook MC, Krouse RS. Complications in the long-term colorectal cancer patient. (in press).
© 2009, KAISER PERMANENTE CENTER FOR HEALTH RESEARCH