Download Evaluating Survivorship Care Plans

VOLUME 29 䡠 NUMBER 36 䡠 DECEMBER 20 2011
JOURNAL OF CLINICAL ONCOLOGY
O R I G I N A L
R E P O R T
Evaluating Survivorship Care Plans: Results of a
Randomized, Clinical Trial of Patients With Breast Cancer
Eva Grunfeld, Jim A. Julian, Gregory Pond, Elizabeth Maunsell, Douglas Coyle, Amy Folkes, Anil A. Joy,
Louise Provencher, Daniel Rayson, Dorianne E. Rheaume, Geoffrey A. Porter, Lawrence F. Paszat,
Kathleen I. Pritchard, André Robidoux, Sally Smith, Jonathan Sussman, Susan Dent, Jeffrey Sisler,
Jennifer Wiernikowski, and Mark N. Levine
See accompanying editorial on page 4740
Author affiliations appear at the end of
this article.
Submitted May 5, 2011; accepted
August 18, 2011; published online
ahead of print at www.jco.org on
October 31, 2011.
Supported by grant No. 17423 from
the Canadian Breast Cancer Research
Alliance, and by a clinician scientist
award from the Ontario Institute for
Cancer Research with funds from the
Ontario Ministry of Research and
Innovation (E.G.).
Presented in part at the 47th Annual
Meeting of the American Society of
Clinical Oncology, June 3-7, 2011,
Chicago, IL.
Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this
article.
Clinical Trials repository link available on
JCO.org.
Corresponding author: Eva Grunfeld,
MD, DPhil, FCFP, Ontario Institute for
Cancer Research and Department of
Family and Community Medicine,
University of Toronto, 500 University
Avenue, Room 352, Toronto, Ontario
M5G 1V7, Canada; e-mail: eva
[email protected].
© 2011 by American Society of Clinical
Oncology
A
B
S
T
A
C
T
Purpose
An Institute of Medicine report recommends that patients with cancer receive a survivorship care
plan (SCP). The trial objective was to determine if an SCP for breast cancer survivors improves
patient-reported outcomes.
Patients and Methods
Women with early-stage breast cancer who completed primary treatment at least 3 months
previously were eligible. Consenting patients were allocated within two strata: less than 24
months and ⱖ 24 months since diagnosis. All patients were transferred to their own primary care
physician (PCP) for follow-up. In addition to a discharge visit, the intervention group received an
SCP, which was reviewed during a 30-minute educational session with a nurse, and their PCP
received the SCP and guideline on follow-up. The primary outcome was cancer-related distress at
12 months, assessed by the Impact of Event Scale (IES). Secondary outcomes included quality of
life, patient satisfaction, continuity/coordination of care, and health service measures.
Results
Overall, 408 survivors were enrolled through nine tertiary cancer centers. There were no
differences between groups on cancer-related distress or on any of the patient-reported secondary
outcomes, and there were no differences when the two strata were analyzed separately. More
patients in the intervention than control group correctly identify their PCP as primarily responsible
for follow-up (98.7% v 89.1%; difference, 9.6%; 95% CI, 3.9 to 15.9; P ⫽ .005).
Conclusion
The results do not support the hypothesis that SCPs are beneficial for improving patient-reported
outcomes. Transferring follow-up to PCPs is considered an important strategy to meet the
demand for scarce oncology resources. SCPs were no better than a standard discharge visit with
the oncologist to facilitate transfer.
J Clin Oncol 29:4755-4762. © 2011 by American Society of Clinical Oncology
INTRODUCTION
0732-183X/11/2936-4755/$20.00
DOI: 10.1200/JCO.2011.36.8373
R
The prevalence of cancer survivors is increasing worldwide as a result of the growth and aging of the population and improved survival through earlier diagnosis
from screening and improved treatments. It is estimated that there are approximately 22.4 million survivors globally,1 and 11.7 million are in the United
States, which represents approximately 4% of the
US population.2
In 2006, the Institute of Medicine (IOM) published an influential report that described the heath
care and health system needs of cancer survivors for
“the period following first diagnosis and treatment
and prior to the development of a recurrence of
cancer or death.” 3(p23) The IOM report issued 10
recommendations; chief among them was the recommendation that patients completing primary treatment should be provided with a survivorship care plan
(SCP), described as a “comprehensive care summary and follow-up plan” to be “written by the
principal providers who coordinated oncology
treatment.”3(p151) The key elements of SCPs are a personalized treatment summary, information on possible late and long-term effects, information on signs of
recurrence,guidelinesforfollow-upcare,identification
of providers, recommendations for healthy living, and
identification of supportive care resources.4
Because the growing number of cancer survivors has raised concern about the strain that
© 2011 by American Society of Clinical Oncology
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Copyright © 2011 American
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Clinical Oncology. All rights reserved.
2014
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4755
Grunfeld et al
providing long-term routine follow-up has put on specialist oncology resources,5 SCPs are also viewed as potentially valuable for
facilitating transition from active treatment to survivorship and from
specialist care to routine follow-up in primary care.5-7 Since publication of the IOM report, many organizations internationally have dedicated substantial resources to implementing SCPs.7-12 Although there
is growing literature on SCPs generally, and although they are considered to have face validity,3 there has never been, to our knowledge, a
rigorous evaluation of the benefits of SCPs on patient outcomes.13
Asagroupwithoneofthemostprevalentadultcancersthathasboth
high incidence and greater than 80% long-term survival,14 breast cancer
survivors are an important target population for receipt of SCPs.6 The
objective of this randomized trial was to determine if an SCP for breast
cancer survivors who are ready for transition from oncologist care
to follow-up with their own primary care physician (PCP) improves patient-reported outcomes. We hypothesized that patientreported outcomes would be positively affected by an SCP up to 12
months after random assignment.
PATIENTS AND METHODS
Trial Patients
Trial participants were women with early stage breast cancer who
completed primary treatment at least 3 months previously, except for
continued use of tamoxifen or an aromatase inhibitor, and who were
without recurrent or new primary cancer. Patients were excluded if they
were still experiencing complications of primary treatment, did not have a
PCP to provide care, were previously enrolled on a study requiring oncology follow-up, were actively followed up for another primary cancer, or
had a PCP who already had a patient enrolled on the trial (to avoid
contamination). Exclusion criteria were minimal to maximize generalizability.15 Because survivors who have been in oncology follow-up longterm are less likely to accept transfer to the PCP and are more likely to
experience anxiety,16,17 the effectiveness of the intervention was expected
to be different for those who had been in oncology follow-up for a longer
period. Therefore patients were randomly assigned within two strata: those
diagnosed less than 24 months or diagnosed ⱖ 24 months earlier.
All trial participants gave written informed consent. The trial was
approved by the ethics committees of each participating center. Patients
were enrolled between April 2007 and July 2009 and were followed up for
2 years.
Design and Intervention
We conducted a multicenter, randomized trial. Those collecting outcome data remained blinded to the treatment allocation group. The intervention was developed by using an implementation framework18 with input from
oncologist, PCP, and patient perspectives to identify barriers and supports
to transition from oncologist to routine follow-up in primary care. The
intervention was developed to be practical and as consistent with usual
practice as possible so as to be generalizable to both oncology and primary
care settings.
Assessed for eligibility
(N = 1,109)
Excluded
Enrolled in another study
Unable to comply with protocol
On or candidate for Herceptin
PCP already in study
Other
Approached
Declined participation
Randomly assigned
(n = 408)
Allocated to control
No SCP group
Strata: < 24 months
≥ 24 months
(n = 208)
n = 91)
(n = 117)
Transferred to PCP
(n = 203)
Recurrence
(n = 1)
Patient withdrawal
(n = 1)
Investigation of recurrence
(n = 1)
Patient moved
(n = 1)
Lost to follow-up
(n = 1)
Analyzed
Completed questionnaires
Baseline
3 months
6 months
12 months
4756
(n = 186)†
(n = 207)
(n = 169)
(n = 164)
(n = 153)
© 2011 by American Society of Clinical Oncology
Allocated to intervention
SCP group
(n = 200)
Strata: < 24 months
n = 89)
≥ 24 months
(n = 111)
(n = 191)
Transferred to PCP
(n = 3)
Recurrence
(n = 4)
Patient withdrawal
(n = 1)
Investigation of recurrence
(n = 1)
Lost to follow-up
Analyzed
Completed questionnaires
Baseline
3 months
6 months
12 months
(n = 472)
(n = 217)
(n = 70)
(n = 57)
(n = 49)
(n = 83)*
(n = 637)
(n = 229)
Fig 1. Trial flow diagram. (*) Details of
other reasons include the following: primary treatment, fewer than 3 months
(n ⫽ 13); under investigation for recurrence (n ⫽ 20); no community-based primary care physician (PCP; n ⫽ 30);
actively followed up for another cancer
(n ⫽ 20). Four patients met two exclusion
criteria: primary treatment for fewer than
3 months and previously enrolled on other
study (n ⫽ 1), and previously enrolled on
other study and actively followed up for
another cancer (n ⫽ 3). (†) Transferred to
PCP and completed at least one postbaseline questionnaire. SCP, survivorship care plan.
(n = 170)†
(n = 200)
(n = 163)
(n = 154)
(n = 146)
JOURNAL OF CLINICAL ONCOLOGY
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Copyright © 2011 American
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Evaluating Cancer Survivorship Care Plans
Table 1. Baseline Demographic and Clinical Characteristics by Trial Group
Control: No
Survivorship
Care Plan
(n ⫽ 208)
Baseline Characteristic
Age, years
Mean
SD
Education
Less than secondary
Completed secondary
Postsecondary
Unknown
Marital status
Single
Married/cohabiting
Widow
Separated/divorced
Tumor grade
1
2
3
Unknown
Tumor size, cm
0 to 1.9
2 to 4.9
ⱖ5
Unknown
No.of positive nodes
0
1 to 3
ⱖ4
Unknown
Type of surgery
Mastectomy
Breast-conserving surgery
Type of treatment
Radiation
Chemotherapy
Hormonal therapy
Tamoxifen
Aromatase inhibitor
Time from diagnosis, monthsⴱ
Stratum ⬍ 24
Median
Range
Stratum ⱖ 24
Median
Range
All patients
Median
Range
Baseline patient-reported
measure
Cancer-specific distress:
IES
Intrusion
Mean
SD
Avoidance
Mean
SD
No.
%
No.
Table 1. Baseline Demographic and Clinical Characteristics by Trial
Group (continued)
%
Baseline Characteristic
61.7
10.2
13
57
109
29
6
27
52
14
19
54
103
24
10
27
52
12
29
130
21
28
14
63
10
14
19
142
18
20
10
71
9
10
49
76
64
19
24
37
31
9
42
82
57
19
21
41
29
10
116
73
11
8
56
35
5
4
124
59
8
9
62
30
4
5
143
43
20
2
69
21
10
1
133
49
17
1
67
25
9
1
56
152
27
73
57
143
29
72
171
89
154
108
67
82
43
74
52
32
162
86
135
109
52
81
43
68
55
26
11.2
3.5-23.8
12.4
3.6-29.2
80.1
3.7-300
82.3
11.8-375
35.3
3.5-300
35.3
3.6-375
8.1
7.3
8.4
7.9
10.7
18.0
12.0
10.2
Control: No
Survivorship
Care Plan
(n ⫽ 208)
Intervention:
Survivorship
Care Plan
(n ⫽ 200)
No.
No.
%
%
Total score
61.2
10.4
(continued in next column)
www.jco.org
Intervention:
Survivorship
Care Plan
(n ⫽ 200)
Mean
18.9
20.4
SD
14.5
16.3
Mean
49
49
SD
9
9
Mean
50
51
SD
11
9
Mean
75
76
SD
19
19
Health-related quality of life: SF-36
Physical component scale
Mental component scale
Patient satisfaction questionnaire
Physician primarily responsible for
follow-up†
Primary care physician
68
33
67
34
Cancer physician
113
54
113
57
Cancer surgeon
36
17
30
15
Other
15
7
9
5
No response
10
5
7
4
Abbreviations: IES, Impact of Events Scale; SD, standard deviation; SF-36,
short-form 36 of the health-related quality-of-life questionnaire.
ⴱ
Five patients were randomly assigned on the basis of incorrect stratification information.
†Some patients indicated multiple providers.
The control condition, which applied to patients both in control (ie, no
SCP) and intervention (ie, SCP) groups, all routine follow-up care was transferred to the patient’s own PCP. All cancer specialists involved in the patient’s
follow-up care (ie, surgical, radiation, and medical) agreed to the transfer so
that all patients were under exclusive PCP follow-up. Patients had a standard
discharge visit with the oncologist, and a discharge letter was sent to the PCP,
which was consistent with usual practice. There was an instruction to PCPs to
refer patients back to the oncologist if a recurrence or new primary cancer
developed and an instruction both to patients and PCPs to schedule the
first follow-up visit in approximately 3 months (all subsequent visits were
arranged between the patient and PCP). In addition, patients were able to
access any supportive care services available at the cancer center according
to usual procedures.
Patients in the intervention group additionally received a comprehensive SCP that consisted of the prescribed elements, including a personalized treatment summary,4 a patient version of the Canadian national
follow-up guideline,19 a summary table of the guideline that served as a
reminder system, and a resource kit tailored to the patient’s needs on
available supportive care resources. These documents were compiled in a
binder and were reviewed with the patient during a 30-minute educational
session with a nurse, who also made an explicit statement that follow-up
care was now the responsibility of the PCP and that access to the oncologist
was available when needed. These documents were also sent to the patient’s
PCP together with the full follow-up guideline,20 a user-friendly summary
version, and a reminder table.
Recruitment and Follow-Up
Patients were enrolled through nine tertiary care cancer centers throughout Canada, where they received adjuvant treatment and were receiving
© 2011 by American Society of Clinical Oncology
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4757
Grunfeld et al
routine follow-up care. After providing informed consent, eligible patients
were allocated according to a prescribed computer-generated center and
stratum-specific randomization schedule in a 1:1 ratio to either the intervention or control group. Concealed allocation was performed by contacting the
trial coordination center of the Ontario Clinical Oncology Group by telephone. Assessments were completed at baseline and at 3, 6, 12, 18, and 24
months. All patients were followed up for recurrence or death. We report here
the 12-month primary outcome assessment.
Outcomes
Trial outcomes were selected to measure the objectives and expected
benefits of SCPs. Patient-reported outcomes were used to measure the domains of cancer-specific distress (ie, Impact of Events Scale [IES])21; general
psychological distress (ie, profile of mood states [POMS]),22 for which higher
scores indicate worse distress; health-related quality of life (ie, short form 36
physical and mental component summaries [ie, short-form 36 of the healthrelated quality-of-life questionnaire, PCS and MCS])23; patient satisfaction
Table 2. Trial Outcomes
Outcome Score
At 3 Months
SCP
Variable
Cancer-specific distress by
IES
Intrusion
Avoidance
a
Total score
Psychologic distress by
POMS
Tension/anxiety
Depression/dejection
Anger/hostility
Fatigue/inertia
Confusion/bewilderment
Vigor/activity
Total scoreb
Patient satisfaction by
PSQ
General satisfaction
Technical quality
Communication
Financial aspect
Time spent with doctor
Accessibility and
convenience
Total scorec,d
General health status by
SF-36e
Physical component
scale
Mental component scale
Continuity of care by
CCCQd,f
Informational
Management
Relational
Total score
Physician primarily
responsible for
follow-up, %g
Primary care physician
Cancer physician
Cancer surgeon
Other
At 6 Months
No SCP
SCP
At 12 Months
No SCP
SCP
Mean
SD
Mean
SD
Difference
95% CI for
Difference
Mean
SD
Mean
SD
Difference
7.3
10.0
17.4
7.3
9.5
15.4
7.4
9.7
17.1
7.1
8.9
14.3
⫺0.1
0.3
0.2
⫺1.6 to 1.4
⫺1.7 to 2.3
⫺3.0 to 3.4
6.7
10.5
17.2
7.0
9.9
15.1
7.5
10.5
18.0
7.2
9.2
14.8
⫺0.8
0.0
⫺0.8
2.9
2.2
2.1
4.7
3.7
9.7
8.8
3.3
3.1
3.0
4.2
1.9
4.6
12.8
3.3
2.5
2.3
4.9
3.9
9.7
9.9
3.4
3.5
3.2
4.4
2.1
4.5
14.6
⫺0.3
⫺0.4
⫺0.2
⫺0.2
⫺0.1
0.0
⫺1.0
⫺1.1 to 0.4
⫺1.1 to 0.4
⫺0.9 to 0.5
⫺1.1 to 0.8
⫺0.6 to 0.3
⫺1.0 to 1.0
⫺4.0 to 1.9
2.2
1.7
1.6
4.2
3.3
9.5
6.6
2.5
2.5
2.2
3.7
1.6
4.6
9.6
2.9
2.3
2.3
4.8
3.8
9.6
9.5
3.4
3.6
3.2
4.6
2.5
4.7
15.3
⫺0.6
⫺0.6
⫺0.7
⫺0.6
⫺0.6
⫺0.2
⫺2.9
95% CI for
Difference
No SCP
95% CI for
Difference
Mean
SD
Mean
SD
Difference
⫺2.3 to 0.8
⫺2.1 to 2.1
⫺4.1 to 2.5
6.5
9.6
16.1
7.1
10.2
15.8
7.2
9.6
16.8
7.6
9.0
15.2
⫺0.7
⫺0.0
⫺0.7
⫺2.3 to 1.0
⫺2.1 to 2.1
⫺4.1 to 2.8
⫺1.3 to 0.0
⫺1.3 to 0.1
⫺1.3 to ⫺0.1
⫺1.5 to 0.3
⫺1.0 to ⫺0.1
⫺1.2 to 0.9
⫺5.7 to ⫺0.1
2.5
2.1
2.1
4.5
3.5
10.1
7.7
3.0
3.0
3.0
4.1
1.8
4.8
12.0
3.2
2.4
2.4
5.4
3.8
9.8
10.3
3.5
3.4
3.4
5.0
2.2
4.8
15.1
⫺0.7
⫺0.3
⫺0.3
⫺0.9
⫺0.3
0.3
⫺2.6
⫺1.4 to 0.0
⫺1.0 to 0.4
⫺1.0 to 0.4
⫺1.9 to 0.1
⫺0.7 to 0.2
⫺0.7 to 1.4
⫺5.6 to 0.5
73
74
74
81
71
18
15
16
18
19
69
72
72
80
68
20
16
18
18
22
3.9
1.9
1.5
0.9
3.4
⫺0.2 to 8.0
⫺1.4 to 5.2
⫺2.2 to 5.1
⫺3.0 to 4.7
⫺1.0 to 7.8
72
73
75
80
71
21
16
16
19
20
71
71
72
80
67
21
16
18
16
20
1.9
1.2
3.0
0.3
3.8
⫺2.7 to 6.5
⫺2.3 to 4.8
⫺0.7 to 6.8
⫺3.6 to 4.1
⫺0.6 to 8.2
69
70
74
79
70
21
17
16
19
20
71
73
72
82
68
21
17
20
17
20
⫺2.3
⫺2.9
1.4
⫺2.7
2.0
⫺7.1 to 2.5
⫺6.8 to 0.9
⫺2.6 to 5.5
⫺6.6 to 1.3
⫺2.5 to 6.4
63
72
19
13
61
70
18
14
1.6
2.2
⫺2.4 to 5.5
⫺0.6 to 5.1
63
72
19
14
61
70
18
14
1.5
2.0
⫺2.6 to 5.6
⫺1.1 to 5.1
61
70
20
14
63
71
16
14
⫺2.1
⫺1.1
⫺6.1 to 1.8
⫺4.2 to 1.9
48
51
9
9
49
50
9
11
⫺1.1
0.8
⫺3.0 to 0.8
⫺1.4 to 3.1
49
52
9
9
49
49
9
11
0.0
2.6
⫺2.0 to 2.0
0.4 to 4.8
48
51
9
9
48
50
9
11
⫺0.2
1.8
⫺2.3 to 1.8
⫺0.4 to 4.1
0.1
⫺0.0
0.1
0.0
⫺0.1 to 0.2
⫺0.1 to 0.1
⫺0.1 to 0.2
⫺0.1 to 0.1
3.7
3.6
3.9
3.6
0.2
⫺0.0
0.1
0.1
⫺0.0 to 0.3
⫺0.1 to 0.1
⫺0.1 to 0.3
⫺0.1 to 0.2
3.5
3.5
3.8
3.6
0.0
⫺0.1
⫺0.0
⫺0.0
⫺0.2 to 0.2
⫺0.2 to 0.1
⫺0.2 to 0.2
⫺0.1 to 0.1
⫺2.5 to 10.2
96.1
2.6
1.3
1.3
2.8
⫺2.9 to 8.5
98.7
0.7
1.3
1.3
3.6
3.6
3.9
3.6
92.8
4.8
4.2
3.6
0.7
0.5
0.7
0.4
3.5
3.6
3.8
3.6
0.8
0.5
0.7
0.5
88.9
7.6
7.0
4.1
3.8
0.8
0.6
0.7
0.5
3.5
3.6
3.8
3.6
93.3
4.8
3.6
3.0
0.8
0.5
0.8
0.5
0.7
0.5
0.7
0.4
3.5
3.6
3.8
3.6
89.1
5.1
6.4
1.9
0.7
0.5
0.7
0.5
9.6
3.9 to 15.9h
Abbreviations: CCCQ, continuity/coordination of care; IES, Impact of Events Scale; POMS, profile of mood states; PSQ, personal satisfaction questionnaire; SCP,
survivorship care plan; SD, standard deviation; SF-36, short-form 36 of the health-related quality-of-life questionnaire.
a
Theoretical range is 0 to 75; higher scores indicate greater distress.
b
Theoretical range is 0 to 100; higher scores indicate greater distress.
c
Theoretical range is 0 to 100; higher scores indicate greater satisfaction.
d
PSQ interpersonal manner subscale and CCCQ patient preference subscale had ␣ ⬍ .7, which suggests poor reliability in this patient group; therefore, results are
not shown.
e
SF-36 physical and mental component scales are standardized and weighted to have a mean of 50 and SD of 10 in the US general population; higher scores indicate
better functioning.
f
Theoretical range is 0 to 5; higher scores indicate better continuity/coordination.
g
Some patients indicated multiple providers. Denominator is the number of patients who listed at least one provider.
h
Difference in the proportion of patients who named their primary care physician as primarily responsible; P ⫽ .0005.
4758
© 2011 by American Society of Clinical Oncology
JOURNAL OF CLINICAL ONCOLOGY
Information downloaded from jco.ascopubs.org and provided by at ST LUCAS ANDREAS ZIEKENHUIS on September 24,
Copyright © 2011 American
Society
Clinical Oncology. All rights reserved.
2014
fromof85.90.80.12
Evaluating Cancer Survivorship Care Plans
(ie, Medical Outcomes Study-Patient Satisfaction Questionnaire [MOS-PSQ])24;
andcontinuity/coordinationofcare(ie,CCCQ),25 forwhichhigherscoresindicate
better quality of life, satisfaction, and continuity and coordination of care.
The primary instrument in this trial was the IES, which assesses
distress anchored to a specific event, defined as breast cancer. Cancerspecific distress rather than general distress was considered most relevant,
both for this patient population and for the trial intervention.22,26,27 The
IES has been validated extensively21 in English and French and has been
used widely in breast cancer populations.22,27-29 The instrument consists of 15
questions, each with four choices, that have scores ranging from 0 to 5 (for
which higher scores represent a more stressful impact); the IES total score
ranges from 0 to 75. It comprises two subscales, intrusion (score range, 0 to 35)
and avoidance (score range, 0 to 40).
The primary outcome was the change in IES total score from baseline to
12 months. Secondary outcomes included a similar change in the total score
and subscales of the following patient-reported measures: POMS, healthrelated quality of life short form 36, MOS-PSQ, and CCCQ. Health services
outcomes included the frequency with which patients declined transfer to
PCP, the frequency and types of postdischarge visits to the oncologist, and the
awareness of which physician was primarily responsible for follow-up care.
The primary analysis was based on a two-sample t test for the change in
IES total score from baseline to 12 months, with imputation of 6-month data
for those missing 12-month data within each stratum. Supportive linear regression analyses were performed to investigate the effect of the intervention
and strata on the 12-month scores after analysis was adjusted for the baseline
score, age in years, education, tumor grade, and number of months since
diagnosis. Additionally, an analysis of covariance model with 12-month absolute IES scores as the outcome and baseline IES scores and intervention group
as covariates was performed. Intervention effects within stratum were assessed
in the multivariable model. Profiles of the various scores over time were
investigated by using a repeated-measures, linear, mixed model that adjusted for the baseline score, age in years, education, tumor grade, and
number of months since diagnosis. The proportion of patients naming
their PCP as primarily responsible for their care was calculated, and the
number of patients who reported at least one physician responsible was in
the denominator. The difference between groups was estimated by using the
continuity-corrected score statistic. All statistical analyses were performed
with SAS, version 9.1(SAS Institute, Cary, NC) or R software, version
2.7.1 (www.r-project.org).
Statistical Analysis
Sample size was calculated to detect a six-point change in IES total score
within each stratum separately by using a two-sample t test. A change of that
magnitude was considered clinically important on the basis of the results of a
previous trial in a similar patient population29; it corresponds to an effect size
of 0.46. The level of significance within each stratum was set to ␣ ⫽ .025 (two
sided) to account for the multiple testing. To obtain 80% power and allow for
10% dropout, 100 patients per group per strata were targeted.
Intention-to-treat analyses were performed within each stratum separately and were combined across strata. Results within stratum were similar to
the combined analysis; hence, only the combined results are presented for
brevity. Descriptive statistics summarized patient characteristics and baseline
measures by randomized group. Means and standard deviations (SDs) summarized outcome measures at 3, 6, and 12 months after baseline, and 95% CIs
for the difference in means were constructed at each assessment time for total
scores and subscale scores. Scoring was performed according to the recommended procedures for each instrument.25,30-33
For all measures, the within-patient change from baseline scores was calculated as the postbaseline score minus the baseline score. For outcomes in which
scoreswithahighvalueindicateaworseoutcome(ie,IES,POMS),anegativevalue
indicates improvement from baseline, and a positive value indicates worsening
from baseline. For outcomes in which high scores indicate better functioning (ie,
PCS, MCS, MOS-PSQ, and CCCQ), a negative value indicates worsened function,
and a positive value indicates improvement. The difference in means between
treatment groups was calculated as the intervention score minus the control score:
a positive value indicates that the average intervention score was higher than the
average control score, indicating a worse outcome for IES and POMS and a better
outcome for PCS, MCS, MOS-PSQ, and CCCQ.
RESULTS
Trial Patients
Of the eligible patients, 64% agreed to participate (Fig 1) and to
accept transfer to the PCP for routine follow-up. Overall, 408 breast
cancer survivors were enrolled: 180 were enrolled in the stratum of
fewer than 24 months, and 228 were enrolled in the stratum of ⱖ 24
months. Baseline characteristics were balanced between the two trial
groups (Table 1). Greater than two thirds of patients had nodenegative tumors and received breast-conserving surgery and adjuvant
radiation and hormonal therapy; approximately 40% received adjuvant chemotherapy. The mean time from diagnosis to enrollment was
35 months, and the maximum time was 300 months (38% were
diagnosed greater than 6 years previously).
Patient Outcomes
The results up to the 12-month visit are reported. There were no
statistically significant or clinically important between-group differences on total scores, subscale scores (Table 2), or change scores (Table
3) on any outcome measure at any time point. The between-group
comparisons of change from baseline on total and selected subscale
scores are shown in Figure 2. All patients showed a non– clinically
important improvement over time in the primary outcome for both
IES total scores and subscale scores. At 12 months, changes in the IES
Table 3. IES Total Score: Change From Baseline to 12 Months by Intervention and Time Since Diagnosis
Group
Patients diagnosed at ⬍ 24 months
No SCP
SCP
Patients diagnosed at ⱖ 24 months
No SCP
SCP
All patients
No SCP
SCP
At Baseline
At 12 Months
Change
Effect of SCP Intervention
No. of
Patients
Mean
SD
Mean
SD
Mean
SD
Mean
95% CI
P
80
74
21.1
20.9
15.3
15.3
18.4
18.0
15.0
16.2
⫺2.7
⫺2.9
13.1
11.3
⫺0.3
⫺4.2 to 3.7
.90
100
91
17.1
18.0
13.2
15.8
16.8
15.0
15.4
15.2
⫺0.3
⫺3.0
12.6
13.5
⫺2.6
⫺6.4 to 1.1
.16
180
165
18.9
19.3
14.2
15.6
17.5
16.4
15.2
15.7
⫺1.4
⫺2.9
12.8
12.5
⫺1.6
⫺4.3 to 1.1
.25
Abbreviations: IES, Impact of Events Scale; SCP, survivorship care plan; SD, standard deviation.
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2014
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4759
Grunfeld et al
A
SCP
No SCP
B
PSQ
IES: Total
6
0
6
SCP
No SCP
0
-6
-6
0
3
6
9
12
0
3
Time (months)
C
SCP
No SCP
SF-36: PCS
IES: Intrusion
D
0
0
SCP
No SCP
6
0
3
6
9
12
0
3
Time (months)
SCP
No SCP
F
SF-36: MCS
IES:Avoidance
6
9
12
Time (months)
4
0
-4
SCP
No SCP
6
Fig 2. Trial outcomes: change scores
over time. Blue line, supportive care plan
(SCP) group; gold line, no SCP. CCCQ,
Continuity/Coordination of Care; IES, Impact of Events Scale; POMS, profile of
mood states; PSQ, personal satisfaction
questionnaire; SF-36, short-form 36 of the
health-related quality-of-life questionnaire.
0
-6
0
3
6
9
12
0
3
Time (months)
6
9
12
Time (months)
SCP
No SCP
0
SCP
No SCP
0.3
CCCQ
4
POMS
12
-6
-4
G
9
Time (months)
4
E
6
0
-0.3
-4
0
3
6
9
12
0
Time (months)
3
6
9
12
Time (months)
total score overall, and within the strata defined by time since diagnosis, were reduced in the intervention group, but the effects were not
statistically significant (Table 3). The analysis of covariance model
showed no statistically significant effect for intervention (P ⫽ .26) on
the 12-month IES total score overall after analysis was adjusted for
baseline IES total score, nor within either stratum (P ⫽ .18 for ⱖ 24
months since diagnosis and P ⫽ .87 for ⬍ 24 months since diagnosis).
The intervention estimates were only minimally affected by the adjustment modeling, and there was no statistically significant interaction
effect (P ⫽ .38) between intervention and time since diagnosis.
(7.9%) had an oncologist visit. These visits were for suspected recurrence (n ⫽ 6 control and n ⫽ 10 intervention), consideration for an
aromatase inhibitor (n ⫽ 5 control and n ⫽ 9 intervention), and
routine follow-up (n ⫽ 6 control and n ⫽ 2 intervention).
Greater than 89% of patients were able to correctly identify their
PCP as primarily responsible for follow-up, although fewer control
than intervention patients could do so at each assessment (Table 2). At
12 months, this difference was statistically significant (89.1% v 98.7%;
9.6% difference; 95% CI, 3.9 to 15.9; P ⫽ .005).
Health Service Outcomes
Five control and nine intervention patients were not transferred
to the PCP for follow-up as a result of reasons related to recurrence or
other reasons (n ⫽ 1 control and n ⫽ 4 intervention). After transfer to
the PCP, 16 control patients (7.8%) and 15 intervention patients
DISCUSSION
4760
© 2011 by American Society of Clinical Oncology
The results of this trial do not support the hypothesis that SCPs are
beneficial for improving patient-reported outcomes of breast cancer
survivors. We found no benefit on any outcomes either transiently
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Evaluating Cancer Survivorship Care Plans
(proximal to the time of transfer to primary care) or at 12 months,
which was our primary outcome.
Alternative explanations for why we found no differences in
cancer-related distress and other outcomes need consideration. The
patient-reported outcomes studied were selected to align with the
anticipated benefits of SCP to improve cancer-related and general
distress, overall health-related quality of life, patient satisfaction, continuity/coordination of care, and transition to primary care.6,7,13 Still,
the IES may not have been sensitive enough to capture some intervention effects. Clinical outcomes, such as recurrence rates or survival,
were not studied, because they are not expected to be affected by SCPs.
We have already shown previously that other clinical outcomes, such
as delay in diagnosing recurrence34 or the rate of serious clinical
events,35 are not negatively affected by exclusive PCP follow-up. We
considered using empowerment, defined as feeling more in control
and better able to manage the multifaceted challenges of the cancer
experience,36 as the main outcome. However, no instruments validated for patients with cancer were available at the time of trial implementation. An additional consideration is the choice of patient
population. It may be that these patients were better adjusted as a result
of the time since their original cancer diagnosis, or that breast cancer
patients are relatively well informed and have good access to resources
compared with those who have other cancers. Thus, our results do not
inform as to whether SCPs could be beneficial for other cancer groups,
suchaspatientswithprostateandcolorectalcancer,orforaselectedgroup
of breast cancer survivors who have greater needs, by using a needs-based
stratified approach. The trial findings are generalizable to settings where
PCPs are available to provide survivorship care. In such settings, provider
satisfaction and PCP knowledge acquisition as a result of SCPs are important topics for additional research, particularly the extent to which
the SCP met the needs of PCPs for providing survivorship care.37
We believe that the results of this trial can be generalized to other
breast cancer survivors who are ready for transition to follow-up care
with a PCP: the HRQOLs resembled that of other Canadian and
American women who had completed primary breast cancer treatment.38,39 This trial also supports the findings of our previous trials,
which found that transfer of follow-up care to PCPs does not negatively affect a range of patient-reported outcomes.34,35
Transferring routine follow-up to primary care is considered
an important strategy to meet the future demand for oncology
resources.5,6 In the absence to date of research evidence about the
effectiveness of SCPs, SCPs have been perceived as a transition
document to facilitate this transfer from oncology care to primary
care.6,7 The perception has also been that those who have been
followed up longer would be more difficult to transfer and that the
SCP could be an effective tool to facilitate that transfer.6,7 In fact, in
this trial, for which all patients were transferred to their PCP and
one third had been followed up for longer than 5 years (and
maximum of 25 years), most patients in both groups and both
strata maintained their willingness to be transferred to their PCP,
and few patients returned to oncology follow-up after transfer.
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Thus, the SCP did not contribute beyond the control condition of
a standard discharge visit with the oncologist.
It has been shown that patients can be confused about who is
responsible for follow-up care.40 Indeed, at baseline in this trial, one
third of patients identified their PCP as primarily responsible for
follow-up, despite formally receiving follow-up care at the tertiary
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AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS
OF INTEREST
The author(s) indicated no potential conflicts of interest.
AUTHOR CONTRIBUTIONS
Conception and design: Eva Grunfeld, Jim A. Julian, Elizabeth Maunsell,
Douglas Coyle, Amy Folkes, Anil A. Joy, Louise Provencher, Daniel
Rayson, Dorianne E. Rheaume, Geoffrey A. Porter, Lawrence F. Paszat,
Kathleen I. Pritchard, André Robidoux, Jonathan Sussman, Susan Dent,
Jeffrey Sisler, Jennifer Wiernikowski
Provision of study materials or patients: Louise Provencher
Collection and assembly of data: Jim A. Julian, Gregory Pond, Amy
Folkes, Louise Provencher, André Robidoux, Sally Smith,
Mark N. Levine
Data analysis and interpretation: Eva Grunfeld, Jim A. Julian,
Gregory Pond, Elizabeth Maunsell, Douglas Coyle,
Mark N. Levine
Manuscript writing: All authors
Final approval of manuscript: All authors
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Affiliations
Eva Grunfeld, Ontario Institute for Cancer Research; Eva Grunfeld, Lawrence F. Paszat, Kathleen I. Pritchard, University of Toronto; Lawrence F.
Paszat, Institute for Clinical Evaluative Sciences; Kathleen I. Pritchard, Sunnybrook Health Sciences Centre, Toronto; Jim A. Julian, Gregory Pond, Mark
N. Levine, Ontario Clinical Oncology Group; Jim A. Julian, Gregory Pond, Jonathan Sussman, Mark N. Levine, McMaster University; Jonathan
Sussman, Jennifer Wiernikowski, Mark N. Levine, Juravinski Regional Cancer Centre, Hamilton; Douglas Coyle, Ottawa Health Research Institute;
Susan Dent, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Ontario; Elizabeth Maunsell, Unité de recherche en santé des
populations (URESP), Université Laval; Louise Provencher, Centre des Maladies du Sein Deschênes-Fabia, Centre de Recherche FRSQ du CHA
Universitaire de Québec, Québec; André Robidoux, Centre Hospitalier de l’Université de Montréal, Montréal, Québec; Amy Folkes,
Cancer Care Nova Scotia; Daniel Rayson, Dorianne E. Rheaume, Geoffrey A. Porter, Dalhousie University, Halifax, Nova Scotia;
Anil A. Joy, Cross Cancer Institute, University of Alberta, Edmonton, Alberta; Sally Smith, BC Cancer Agency, British Columbia;
Jeffrey Sisler, University of Manitoba, Winnipeg, Manitoba, Canada.
■ ■ ■
4762
© 2011 by American Society of Clinical Oncology
JOURNAL OF CLINICAL ONCOLOGY
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Copyright © 2011 American
Society
Clinical Oncology. All rights reserved.
2014
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