Download Cognitive Changes with Adjuvant Therapy for Breast Cancer

Cognitive Changes with Adjuvant
Therapy for Breast Cancer:
A Longitudinal Study
Michael Jameson, Barbara Hedge, Robyn Segedin,
Stephanie Campbell-Wilson, Jenny Boyd
Oncology Dept, Waikato Hospital, Hamilton, NZ
University of Waikato
PONZ 2011
Perhaps better entitled….
Where Possibilities Meet
Practicalities –
The Challenges of
Undertaking Longitudinal
Psycho-oncology Research
in NZ
Outline







The great idea
The research plan
The hurdles
More hurdles…
Yet more of those @#**!! hurdles….
Limping across the finish line…
Not the results 
Background

2575 cases of breast cancer in NZ in 2007
– Approx 75% will not die from breast cancer

Mortality is falling due to:
– Earlier diagnosis from screening programmes
– Adjuvant therapy

Women with breast cancer are one of the
largest groups of cancer survivors
– Quality of life experienced by cancer survivors is
of great importance
– What is the impact of adjuvant therapies on QOL?
Adjuvant Therapy

Treatment given after surgery
– Reduce risk of relapse and death

Radiotherapy
– Conserved breast or chest wall +/- nodes

Chemotherapy
– Systemic treatment, usually IV drugs

Hormone therapy
– 5 years
– May precipitate or mimic menopause
Adjuvant Therapy


Little is known about long-term effects of
adjuvant therapy on QOL, especially chemo
Long term effects possibly due to:
– Direct effects of chemo or hormones on brain
“chemo brain”
– Induction of menopause
– Psychological effects of cancer diagnosis
– Psychological effects of treatment
» Altered body image from surgery +/- chemo +/- RT
– Fatigue
– Alcohol, smoking, drugs
Effects of Adjuvant Therapy
on Cognitive Function


Only preliminary studies by 2003
Chemotherapy:
– Impaired memory and concentration
– Stressful, associated with poor quality of life
– Effects common at 6 months
– Persistent in 1/3 10 years after high-dose chemo

Hormone therapy (tamoxifen)
– Blocks oestrogen
– Associated with depression
Chemo and Cognitive Function

Generally cohort studies
– One group before, another after treatment
– No comparison of individual changes

Longitudinal studies
– Toronto – breast cancer only
» simple instrument
» not discriminating among domains
» poor correlation with patient perceptions
– Dunedin – breast and bowel cancer
» Changes noted in some domains
» complex assessment
» Requires clinical psychologist to administer
Brezden, JCO 2000;18:2695
Peace, PONZ 2003
Waikato Initiative 2003

Clear need for:
– Prospective longitudinal study
» Pre-treatment baseline
» Repeated assessment in each patient
– Look at other psychological and medical factors
– Battery of tests that:
» Focuses on identified problem areas
» Easy to train non-psychologist to use

? Suitable for Master of Nursing project
– Too long
Objectives


investigate the incidence, time course and
recovery of deficits in cognitive function
associated with adjuvant therapies for
breast cancer over a 2 year period
i.e. how bad does it get, and how quickly
and completely does it recover?
Objectives

Specifically look at :
– Verbal memory
– Concentration
– Speed of mental processing
– Motor functioning


Explore changes in quality of life, fatigue
and mood during adjuvant therapies for
breast cancer
Examine the roles played by menopausal
status, fatigue and mood in cognitive
functioning during adjuvant therapies
Study Design

Eligible women:
– Have had surgery for breast cancer
– Adjuvant therapy is planned
– No current meds that affect cognitive function
– No current severe mental illness
Comparisons

Each woman serves as her own control
– See changes over time
– Completeness of recovery

Comparator groups:
– RT alone
– Tamoxifen alone
– Chemo alone
– Any combination of the above
– Induced menopause or not
Assessments
1
2
3
Baseline 3 months 6 months
Prepostpostadjuvant baseline baseline
treatment
4
5
1 year
postbaseline
2 years
postbaseline
Assessments

Demographics and medical history
• Includes age, gender, ethnic group, educational
level achieved, occupation, marital status,
number of children, number of co-habitants,
stage of breast cancer
• Menopausal status
• Current regular medication
• Drug and alcohol intake
• If employed and, if so, hours per week
• Adjuvant therapy (start and stop dates, type)
Assessments

Mood
– Hospital Anxiety and Depression Scale

Fatigue
– Multidimensional Fatigue Symptom Inventory
– Visual analogue scales
» mental tiredness
» physical tiredness

Quality of life
– QLQ-C30
Assessments

Cognitive functioning
– Psychomotor function
» Digit symbol
» Trail making
– Concentration
» Digit span
– Motor function
» Grooved pegboard
– Verbal memory
» Word recall test
» Logical memory
Trail
Making
B
Grooved Pegboard
Assessments

Cognitive failures questionnaire
Everyday memory questionnaire

Each assessment takes about:

– 60 mins first time
– 45 mins subsequently
Research Plan

3 Centres
– Waikato, Tauranga, Whakatane
– Train a nurse in each centre
– Clinical psychology student at Waikato

Funding:
– Equipment and forms needed
– Travel expenses for patients & staff
» Waikato Medical Research Foundation
» Genesis Oncology Trust
– Research nurses already employed
– Nursing staff at other centres would do it in
working hours
Progress
Started late 2003
 Student finished end 2004

–Difficult for man to recruit women!
–Poor recruitment in Oncology Dept and
Breast Care Centre
» Disinterest?
» Lack of research culture

Other centres insisted on nursing salaries
– BOP Cancer Research Trust
Progress

Dec 2005 Research nurse employed by WDHB
– 0.5 FTE
– Clerical support
– Funded from trust funds

Recruitment dramatically improved
– recruiting 2–3 per week
– Aiming for 200 patients total

Staff changes at all sites
– 3 in Tauranga
– Stopped in Whakatane
– Added Rotorua briefly
– Succession at Waikato
– Managed to keep trained staff doing most
planned assessments
Progress


Falling enthusiasm and recruitment
Finally recruited 200th patient Sept 2010
– 12 month assessment last month

Database now cleaned and ready for
analysis
– By Prof Barbara Hedge in Liverpool
– Was originally planned with statisticians at
University of Waikato
The Learnings



It may be a great idea but…..
The idea has to have the backing of key
recruiters
It has to be practical
– Realistic recruitment plan and timeline
– Study staff and funding where necessary
– Be completed in a timely fashion

Health research in NZ suffers due to lack of
infrastructure
– Compared to Australia and the UK
– Research nurses, data managers, biostatisticians
The Learnings


Collaborative research between institutions is
challenging
Much better tools are now available
– E.g. Cogstate

Important to have the investigators engaged
throughout
– Difficult across time and distance

Overly ambitious
– Start with a smaller pilot study rather than the
definitive study
Acknowledgments

Genesis Oncology Trust
Waikato Medical Research Foundation
Bay Cancer Research Trust
Waikato DHB (Oncology Trust Fund)

Professor Barbara Hedge



– Clinical Psychologist

Robyn Segedin
– Haematology Clinical Nurse Specialist, Waikato Hospital



Research staff - Cancer Trials Unit, Waikato Hospital
Nursing staff at BOPDHB
Patients