Survivorship care and research

Craig Earle, MD MSc FRCPC

Director, Health Services Research Program for Cancer Care Ontario & the Ontario

Institute for Cancer Research

Objectives(key messages)

1. Communicating with patients about the plan for follow up can go a long way towards decreasing anxiety

2. Be judicious about the intensity of follow-up• www.nccn.org

3. Be open to non-oncologist based models of survivor care

3

Incidence + survival = demand

4

J. Natl. Cancer Inst. 2008 100:236; doi:10.1093/jnci/djn018

• Next 10 years Ontario to see 40% increase in people living with cancer

• By 2017, the estimated number near half a million (406,000)

Survivor Definitions

Medical Model: disease-free 5 yrs after completion of therapy

Advocate: a person with cancer is a survivor from the time of diagnosis through the remainder of life

• National Coalition for Cancer Survivorship. Charter. Silver Spring, MD: National Coalition for Cancer Survivorship, 1986.

• Include family members and caregivers as well?

Cancer Care Trajectory

Current survivorship care models in Canada

Follow-up care in cancer centre

Transfer of care to FP

Variable practices

Follow-up care varies markedly, especially Ontario

Problems with the status quo

1. Dissatisfaction

2. Variable quality of care

3. Workforce issues

1. Dissatisfaction

Ontario Cancer Plan: explicit goal to improve the patient experience along

every step of the cancer journey

A particular area of patient dissatisfaction on survey

12

Communication and information needs

Many survivors have little or no long-term problems, and some

have positive effects

“It’s not over when it’s over”

• Patti Ganz– Journal of Oncology Practice 2006;2(2):79

Myths about Ending Treatment

• I should be celebrating• I should feel well now• I should be back to my pre-cancer self• I shouldn’t need support anymore

Stanton, Ganz,, Rowland, et al Cancer. 2005.

The truth about ending treatment

• Counter to the expectation that treatment completion and full recovery of health and well being occur simultaneously, the literature suggests that treatment completion can be disruptive psychologically.

Promoting adjustment after treatment for cancer Annette L. Stanton, Patricia A. Ganz, Julia H. Rowland,Beth E. Meyerowitz, Janice L. Krupnick, Sharon R. Published Online: 24 Oct 2005

“No one warned me that once treatment was over everything would change. I was like a rock star while I was having treatment--then poof, I’ve been dropped off of the map and no one seems to care much anymore. “

prostate survivor, reflecting on the first few months off treatment

“When I was in treatment, I had all the steps laid out in front of me. I knew what I had to do to fight this disease. Now, I find myself wanting to go to clinic, to be getting chemo, to DO SOMETHING. I am just sitting here, alone now, waiting for it to come back.”

Breast ca survivor, 4 weeks out

From Cancer Patient to Cancer Survivor: Lost in Transition

- Institute of Medicine,

November 2005

(www.iom.edu)

IOM Recommendation #1

• Recognize cancer survivorship as a distinct phase of cancer care

Survivorship is a distinct clinical entity with its own cross-cutting issues

• Surveillance– Recurrence

• Local• Distant

– New cancers• Genetic/environmental predisposition

• Late & persistent effects of treatment– Organ dysfunction, mobility, fatigue, lymphedema,

hormonal/sexuality/fertility, second cancers• Non-cancer care

– Screening/prevention– Other medical conditions– Lifestyle/behavioral interventions

• Employment/insurance (health, life, disability)• Psychosocial

– Fear, relationships, cosmesis, cognitive

IOM Recommendation #2

• Patients completing primary treatment should be provided with a comprehensive care summary and follow-up plan

… (the) ‘survivorship care plan’

Provider-provider communication

Why are there MD communication problems in cancer in particular?• Multidisciplinary care

– An average of > 3 cancer doctors /patient

• Complex – Treatment takes place in a variety of settings

(inpatient, outpatient, specialized facilities) across time and space

– Multiple medical records

• Often takes place in isolation from PCPs

2. Variable quality of care

Follow up practices for breast cancer, Hodgkin’s disease, colorectal cancer,

and endometrial cancer in Ontario

1. Large variation in practice

2. Both over-use and under-use of visits and tests compared to published guidelines

- Grunfeld et al J Oncol Pract. 2010 Jul;6(4):174-81. - Hodgson et al Cancer. 2010 Jul 15;116(14):3417-25)- Kwon et al. Obs Gyn 2009;113(4): 790-795

Surveillance components

• History and Physical

• Blood work, including tumor markers

• Imaging

• Examination of the primary site (e.g., endoscopy, mammography)

Surveillance for recurrence

• Problem: Lack of evidence– ASCO – Strict evidence-based: only breast and colorectal

guidelines (incl. tumor markers)– NCCN – evidence-based consensus (www.nccn.org)– ESMO – evidence-based consensus (Ann Oncol. 2005;16

Suppl 2)– ‘Cancer Patient Follow Up’ (Johnson & Virgo) – Expert opinion

• In some cases, lack of rationale1. Does surveillance detect recurrence earlier than it would

otherwise become apparent?2. If so, does early intervention improve the outcome of recurrent

disease?3. If so, does it do so in a cost-effective manner?

Challenges to surveillance research

• RCTs generally required– Lead time & length time biases

• Large sample size

• Complex strategy

• Long duration– Improving non-curative treatments

• Economic evaluation– Discounting

Rationale for detecting recurrence early

• Improve survival

• Improve QoL– Psychological reassurance– Detect catastrophic complications

• Enroll in clinical trials

• Allow patients to plan/put affairs in order

Risks of overly-aggressive surveillance

• False positives– Mental anguish– Harm from invasive testing– Cost

• False negatives

Intensive surveillance beneficial:

Testicular Cancer• Recurrences are usually within the first 2 yrs

• Successful salvage exists

• Therefore, can treat less aggressively; decrease long-term and late effects without compromising cureHx, Px, markers and imaging every 1-2 months

is as effective as upfront treatment with chemotherapy (NSGCT) or radiation (GCT)

Intensive surveillance not beneficial:

Breast Cancer• Local recurrence and second primaries

can be curedMammography

• Metastatic disease cannot be cured

• Two large RCTs of surveillance(& a meta-analysis of them)– B/W, chest & abdominal imaging, bone scans– No difference in survival or QoL

Intensive surveillance controversial:

Colon Cancer• Local recurrence uncommon; premalignant polyps common => colonoscopy

• < 10% relapse with oligometastatic disease~ 1/3 of those can be cured

• 6 RCTs unable to demonstrate survival benefit– The curable relapses are indolent and would be found

anyway?• Only urgency for metastases => metastases

– Meta-analyses suggest CEA and imaging may slightly improve survival

• If anything, it’s the low-risk patients that benefitASCO surveillance recommendations

Long-term and late effects

Late medical effects:depend on the type of therapy . . .

RadiationTherapy

Surgery

Chemotherapyand the specifictoxicities/organinteractions of each therapy

Common long-term and late effects

Surgery Radiation Chemotherapy•Cosmesis•Functional disability•Pain•Organ damage•Scarring/adhesions•Hernia•Lymphedema•Systemic

–endocrine, spleen

•Second malignancies•Neurocognitive•Dry eyes, cataracts•Xerostomia, caries•Hypothyroidism•CVD, myopathy•Pneumonitis/fibrosis•Strictures, proctitis•Infertility, impotence•Lymphedema•Bone fractures

•MDS, AML•‘Chemo brain’•Cardiomyopathy•Renal toxicity•Menopause•Infertility•Osteoporosis•Neuropathy

The Children’s Oncology Group http://www.survivorshipguidelines.org

CancerSurvivorship

Physical wellbeing & SymptomsFunctional AbilityStrength/Fatigue

Sleep & RestNauseaAppetite

Constipation

Psychological Well BeingControlAnxiety

DepressionEnjoyment/LeisureFear of RecurrenceCognition/Attention

Distress of diagnosis & Treatment

Spiritual Well BeingMeaning of Illness

ReligiosityTranscendence

HopeUncertainty

Social Well BeingFamily Distress

Roles & RelationshipsAffection/Social Function

AppearanceEnjoymentIsolationFinances

Work

Dimensions of quality of life affected by cancer

Non-cancer care

Most patients diagnosed with cancer today will not die from it

Cause of death* %

Heart disease 35.5

Stroke 9.9

Lung cancer 4.3

Pneumonia 3.6

Chronic lung disease 3.0

Diabetes 2.5

Heart failure 2.4

Colon cancer 2.2

Ovarian cancer 1.5

*SEER data on breast cancer survivors

Under use of necessary care among cancer survivors

(Earle & Neville. Cancer 2004;101(8):1712-9)

• 14,884 5-year colorectal survivors, matched to controls

• 44 quality of care indicators, divided into acute and chronic care

• Survivors less likely to receive recommended care for chronic conditions and prevention– Despite having more physician visits

Oncologist’s responsibility to screen for other cancers?

(Cheung et al J Clin Oncol 2009)

None A little Some A lot Full

None 7 4 13 30 26

A little 2 6 27 41 39

Some 10 8 39 44 38

A lot 7 10 23 28 39

Full 1 0 0 2 4

Onc

olog

ists

Survivors (n=448)

Effect of provider type(Colon cancer survivors)

Getting cancer may be a “teachable moment”

3. Workforce issues

Oncologist Supply Demand

Source: J Clin Practice 2007

Survivorship care models

1. Oncologist follow up

2. PCP follow up

3. Dedicated survivorship clinics– Nurse or PA -led

} Shared

Care

Facilitated by treatment summary and care plan

Shared Care as a Solution

Distribution of Office Visits

18%

69%

13%

SharedNot SharedUnknown

Common examples of shared care

• Coronary artery disease• Diabetes• HIV infection• Chronic renal insufficiency• Bipolar disorder• Parkinson’s disease• Inflammatory bowel

disease• Seizure disorders

NAMCS, 2002NAMCS, 2002

Randomized Trial(18 months follow-up)

Trial GroupDifference(95%CI)

PCPn = 148

Specialist n = 141

Time to diagnosis of recurrence (days)

22 days 21 days 1.5 (-13 to 22)

Total time with the patient (min) 35.6 20.7 14.9* (11.3 to18.4)

Cost per patient (£s) 65 195 - 130 * (-149 to -112)

Time cost to the patient (min) 53 82 - 29 * (-37 to -23)

• No difference in health-related quality of life over time• No difference in anxiety or depression over time• PCP patients more satisfied

Results – English RCT

*p<0.001 Grunfeld et al BMJ 1996

Outcome Event PCP

(n=483)

Specialist

(n=485)

Risk Difference

(95% CI)

Number of Patients (%)

Recurrence

Distant

Local

Contralateral

54 (11.2%)

36

10

11

64 (13.2%)

38

12

15

2.02%

(-2.13, 6.16)

Death (All Causes) 29 (6.0%) 30 (6.2%) 0.18% (-2.90, 3.26)

Serious Clinical Events 17 (3.5%) 18 (3.7%) 0.19%

(-2.26, 2.65)

Spinal Cord compression

Pathological fracture

Uncontrolled local recurrence

KPS ≤ 70

Brachial plexopathy

Hypercalcemia

0

3

2

14

0

2

1

8

0

18

0

2

Grunfeld et al. JCO 2006

Canadian RCT Results

Specialist

PCP

Specialist

PCP

Mental QoL

Physical QoL

Specialist

PCP

PCP

Specialist

Patient Satisfaction Questionnaire mean scores from baseline to 3 years

0

20

40

60

80

100

Baseline 6 Months 12 Months 18 Months 24 Months 36 Months

PCP

Specialist

Number of Responses

Specialist 475 439 423 400 389 296

PCP 469 433 411 386 371 277

p <0.0001

Colorectal cancer follow-up: Surgeon vs PCP

• RCT; 203 patients; median follow-up 24 months• PCP provided with a guideline• Outcomes – quality of life; anxiety; satisfaction

- adherence to guideline • No difference in primary outcomes• PCPs-more frequent visits• Surgeon-more frequent imaging and endoscopy

Wattchow et al. BJC 2006;94:1116-1121.

Nurse-led models

Similar results:• No difference in

outcomes• Satisfaction measures

tend to favor nurse-led follow up • Brown et al, 2002

• Moore et al, 2002

• Koinberg et al, 2004

Systematic reviews• Cox, 2003

• Sheppard, 2004

• Lewis, 2009

PCPs are willing to take this on

Barriers to changing the model of survivorship care

Doctors adopt a new practice if it is:

• Obviously better for patients

• Easier (for them)

• Remunerated

Summary1. We’re not meeting our patients’ or our colleagues’ needs in the

survivorship phase– Simple communication can go a long way towards improving care

2. The quality of care is variable – Both overuse and underuse– Most survivorship practices not based on evidence

• Evidence is hard to get

3. There are looming workforce issues Studies show that non-specialist providers can deliver this care Getting physicians to change their model of care is very difficult

Some form of shared care is likely the best solution• Communication is key to making this work• Local care organizations must determine what will work best for them