Download Module 4

CML Learning
Programme
EBMT Slide template
for NursesBarcelona
& Other
Allied
Health Care
7 February
2008
Professionals
The
The European
European Group
Group for
for Blood
Blood and
and Marrow
Marrow Transplantation
Transplantation
Module 4
Support patients living with CML
The European Group for Blood and Marrow Transplantation
Aims of Module 4
• Gain an appreciation of the issues patients living
with CML face on a daily basis
• Understand the education and support they can
offer to CML patients to improve their quality of
life
• Appreciate the pros and cons for patients
considering entering a clinical trial
The European Group for Blood and Marrow Transplantation
Aims of Module 4
• Achieve an understanding of end of life issues in CML
• To understand the common questions that CML
patients ask
• To give nurses an understanding of new treatment
options on the horizon
• To provide contacts of patient support groups
The European Group for Blood and Marrow Transplantation
CML Patient journey
•
•
•
•
•
•
Diagnosis/Crisis
Hope/Starting therapy
Adaptation/ New normal
Uncertainty
Adaptation/ New normal
End of life: Despite new treatments
patients can still die of CML
The European Group for Blood and Marrow Transplantation
Diversity of experience
• It needs to be remembered that patients
experience their disease journeys in different
ways
This may be a function of:
• Individual disease histories – including co morbid
conditions
• How people respond to and tolerate therapies
The European Group for Blood and Marrow Transplantation
Diversity of experience
• Psychosocial and demographic factors
• Life circumstances
• Relationships with the medical team
• Healthcare access
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Diagnosis
• A diagnosis of CML brings a time of acute
distress for patients and their families
• They have to deal with fear of the unknown
• A diagnosis of “cancer” sparks major concerns
about mortality
The European Group for Blood and Marrow Transplantation
Diagnosis
• People with CML find it difficult to appreciate that although
they have been diagnosed with cancer, treatments are
available that offer an excellent chance of getting their
condition under control and allowing them to live normal
life spans
• They find it hard to understand that treatments are not a
“cure”, and that they will need to take medication for the
rest of their lives
The European Group for Blood and Marrow Transplantation
Nursing role at diagnosis
• Nurses need to understand that newly diagnosed patients
have limited ability to take on board new information and may
require a number of sessions
• They need to understand differing levels of education
influence patient’s ability to understand information
• Initially patients should be provided with easy to understand
information and offered the opportunity of follow-up
consultations to ask questions
The European Group for Blood and Marrow Transplantation
Nursing role at diagnosis
• It is helpful to provide written information
• Patients should be encouraged to bring a friend or relative to the
consultation or to record information. They should be told to write
questions down
• Patients may need advice on how to break the news to family members
or work colleagues
• Nurses can provide patients with contact details of support groups
• Younger patients who have yet to start families may wish to consider
banking sperm/eggs
The European Group for Blood and Marrow Transplantation
Starting therapy
• This is the time when patients get to know their new
treatment schedules
• They undergo a process of adaptation in realizing
that their cancer can be brought under control and
that they can lead a “normal” life
• It is also the time when they first start to experience
the side effects of treatment
The European Group for Blood and Marrow Transplantation
Nursing role in starting
therapy
• Patients need to be taught about the importance of
adherence to medication, and the need to inform health care
providers about any other medications they are taking –
whether prescription or over the counter
• Patients need to be informed about the possible side effects
of drugs, and how best to manage them.
They should be provided with educational sessions
and supported with written materials
The European Group for Blood and Marrow Transplantation
Nursing role in starting
therapy
• Be alert for patients who may be experiencing
depression
• The importance of contraception needs to be
addressed in women of child bearing age
• This can be the time to educate patients about
CML monitoring tests
The European Group for Blood and Marrow Transplantation
Nursing role in starting
therapy
• Encourage patients to get organised i.e. introducing
memory aids to take medications and also starting ring
binders to store information
• Patients should be provided with the name of a health care
worker they can contact in an emergency
• Information should be personalised to the patient’s disease,
treatment plan, cognitive level and psychosocial needs
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Adaptation / new normal
A prolonged period of adjustment requiring
changes in behaviour, outlook and life style,
leading to acceptance of a new “normal”
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Nursing role in adaptation
• Continue to provide CML education with increasing levels
of complexity
• Reinforce the importance of adherence. Understand that
when patients start to adapt to their illness is the key time
they forget to take medication
• Patients becoming pregnant by mistake or planning to
start a family will need additional support about options
The European Group for Blood and Marrow Transplantation
Nursing role in adaptation
• Patients may need help considering the physical
restrictions imposed by the disease, symptoms and
treatment
• With many CML patients surviving normal life spans,
nurses will need to consider how issues of ageing, such
as memory loss, impact upon drug adherence
• CML patients may need support with issues like
returning to employment, getting insurance, and getting a
mortgage
The European Group for Blood and Marrow Transplantation
Ongoing uncertainty
• Uncertainty is experienced by patients every time
they receive test results
Even in MMR- (major molecular response), many
patients do not feel in a “safe haven”
• A diagnosis of resistance or intolerance to treatment
or progression of CML leads to renewed anxiety
The European Group for Blood and Marrow Transplantation
Nursing role / uncertainty
• Nurses need to explain to patients that it is the trend in
results over time that is more important than individual
results
• If patients develop resistance, intolerance or progress to
the next stage, nurses will need to explain their options to
them
• This may require patients to make difficult decisions
about stem cell transplantations or entering clinical trials
The European Group for Blood and Marrow Transplantation
Nursing role / uncertainty
• Patients may need repeat explanations about mutations,
resistance or intolerance
• If patients change treatments they will need to be reeducated about how to take their new medications and
the different side effects
• Throughout the patient journey there is an ongoing need
to screen for patients who are coping badly with
psychological stress
The European Group for Blood and Marrow Transplantation
Clinical trials
• Informing patients about clinical trials makes the greatest
difference to trial accrual rates. Patients can not agree to enter
a trial if they are not aware they may qualify
• Informed consent is a process through which people learn the
important facts about a clinical trial to help them decide
whether or not to take part in it
• Information about current clinical trials is available at:
www.clinicaltrials.gov for US information
www.clinicaltrialsregister.eu for European information
The European Group for Blood and Marrow Transplantation
Clinical Trials
Possible benefits of trial participation:
Clinical trials enable patients to:
• Play an active role in their health care
• Gain access to research treatments before they
are widely available
• Obtain medical care at health care facilities
during the trial
• Help others by contributing to medical research
The European Group for Blood and Marrow Transplantation
Clinical Trials
Possible risks for volunteers:
• There may be unpleasant, serious, or even lifethreatening side effects to experimental treatments
• The experimental treatment may not be effective
• The protocol may require more time and attention
than a non-protocol treatment, including trips
to the study site, more treatments, hospital stays,
or complex dosage requirements
The European Group for Blood and Marrow Transplantation
Clinical Trials
• Phase 0 trials represent the earliest step in testing new
treatments in humans, where a very small dose of an agent
is given to approximately 10 to 15 people to gather
preliminary information about pharmacokinetics and
pharmacodynamics
• Phase I trials are conducted to evaluate the safety of
interventions, to determine the maximum dose that can be
given safely and whether such interventions cause harmful
side effects
The European Group for Blood and Marrow Transplantation
Clinical Trials
• Phase II trials test the effectiveness of interventions in
people who have a specific type of cancer or related
cancers.
They continue to look at safety
• Phase III trials compare the effectiveness of new
interventions, or new use of existing interventions, with
the current standard of care
They also consider side effects
The European Group for Blood and Marrow Transplantation
Clinical Trials
• Phase IV trials further evaluate the effectiveness and
long-term safety of drugs or other interventions,
usually taking place after a drug or intervention has
been approved for standard use
• Adapted from www.cancer.gov
The European Group for Blood and Marrow Transplantation
Questions for patients considering
participating in clinical trials
The Study
• What is the purpose of the study?
• Why do researchers think the approach may be effective?
• Who will sponsor the study?
• Who has reviewed and approved the study?
• How are study results and safety of participants being
checked?
• How long will the study last?
• What will my responsibilities be if I participate?
The European Group for Blood and Marrow Transplantation
Questions for patients considering
participating in clinical trials
Possible Risks and Benefits:
• What are my possible short-term benefits?
• What are my possible long-term benefits?
• What are my short-term risks, such as side effects?
• What are my possible long-term risks?
• What other options do people with my type of cancer have?
• How do the possible risks and benefits of this trial compare with
those options?
The European Group for Blood and Marrow Transplantation
Questions for patients considering
participating in clinical trials
Participation and Care:
• What kinds of therapies, procedures and / or tests will I have
during the trial?
• Will they hurt, and if so, for how long?
• How do the tests in the study compare with those I would have
outside of the trial?
• Will I be able to take my regular medications while in the clinical
trial?
• Where will I have my medical care?
• Who will be in charge of my care?
The European Group for Blood and Marrow Transplantation
Questions for patients considering
participating in clinical trials
Personal Issues:
• How could being in this study affect my daily life?
• Can I talk to other people in the study?
www.cancer.gov
The European Group for Blood and Marrow Transplantation
Search for meaning
Positive reappraisal refers to cognitive strategies used to
evaluate an event in a favourable light
The intention is to allow patients to identify positive
outcomes from the stressful event, such as improved
relationships, wisdom, faith, increased competence or
increased self-esteem
The European Group for Blood and Marrow Transplantation
Search for meaning
Problem-focused coping refers to strategies to solve or
alleviate the problem.
While this type of coping focuses on decision-making,
planning and generally taking care of the situation, problemfocused coping is part of searching for meaning because it
involves refocusing priorities to the situation at hand,
evaluating goals in light of priorities, and setting realistic,
attainable goals
Successful problem-focused coping leads to a sense of
personal mastery and control as well as positive
psychological well-being
The European Group for Blood and Marrow Transplantation
Search for meaning
• Revaluing ordinary events – making an ordinary event something special
and significant
Those events or things that are normally taken for granted are sought out,
appreciated and enjoyed (e.g. beautiful scenery or a quiet dinner)
People may also take the time to create positive events or simply just be
thankful for each day
These positive meaning events may be used to offset the negativity
that accompanies stressful situations
Skaggs B. G. and Barron C. R. Journal of Advanced Nursing 2006, 53:559-570
The European Group for Blood and Marrow Transplantation
Planning for end of life
• For many people planning ahead to settle legal, financial and
business affairs can free them to concentrate on the emotional
aspects of completing their lives. Patients can help families by
organising information about bank accounts and insurance
policies in one place
• Resolving conflicts and saying good bye to special people can
bring peace
• It can help to create opportunities to celebrate the patient’s life
and take time to reflect upon things they have accomplished
The European Group for Blood and Marrow Transplantation
Planning for end of life
• Advance directives, such as living wills are legal documents
that allow people to communicate their wishes about
treatment ahead of time to prevent confusion later.
Living wills can include statements about cardiopulmonary
resuscitation, artificial nutrition and hydration and whether
procedures like kidney dialysis should be performed
• Decisions may need to be made by patients about whether
they would prefer to die in a hospice or at home
The European Group for Blood and Marrow Transplantation
Planning for end of life
• Religious belief can offer patients a sense of meaning,
comfort and control when facing a terminal illness.
For others spiritual comfort can lie in a sense of connection
to nature or family and friends.
Fricker J. Planning for the end of life. Help the Aged. 2005
The European Group for Blood and Marrow Transplantation
Anxiety
Symptoms of acute anxiety include:
• a rapid heartbeat or palpitations
• chest pain
• shortness of breath or feeling of being suffocated
• severe sweating
• chills
• hot flashes
• dizziness
• nausea
• trembling
• abdominal pain
• feeling fearful
• high blood pressure
• diarrhoea
The European Group for Blood and Marrow Transplantation
Anxiety
Symptoms of chronic anxiety include:
• insomnia
• muscle tension
• extreme fatigue
• inability to concentrate or make decisions
• being irritable
• excessive worrying
• restlessness
Adapted from www.cancer.net/patients/coping
The European Group for Blood and Marrow Transplantation
Managing Anxiety
Medical and psychological treatments to help patients
manage anxiety include:
- Relaxation techniques
- Counselling support
- Pharmaceutical agents
The European Group for Blood and Marrow Transplantation
Relaxation techniques
The following relaxation techniques can help control
symptoms of anxiety
• Focused breathing
• Muscle relaxation
• Guided imagery
• Meditation
• Hypnosis
• Biofeedback (a method where people use their minds to
control a response from their body, such as heart rate)
• Yoga
The European Group for Blood and Marrow Transplantation
Counselling and support
• Many psychotherapists are trained to work with
people who have anxiety and some specialise in
working with people with cancer
• Some patients prefer individual therapy, while
others prefer group therapy where they can learn
from other people with cancer and provide mutual
support
The European Group for Blood and Marrow Transplantation
Counselling and support
• Support groups can be found through the social
work department of many local hospitals and
medical centres and some patient information
resource groups
• For some, involvement in community or spiritual
activities may also help relieve anxiety
The European Group for Blood and Marrow Transplantation
Medication
People who experience severe anxiety symptoms may
need medication to treat the condition
Treatments include:
• Benzodiazepines
• Selective serotonin reuptake inhibitors (SSRI)
N.B. It is important to check whether any pharmaceutical
agents prescribed to the patient interact with TKIs
The European Group for Blood and Marrow Transplantation
Depression
• Depression is a common problem in oncology, with many
possible causal factors, including disease progression,
treatment-related toxicities, social issues, and fear about
the possibility of death
• A case report from the Dana-Farber Cancer Institute
reported on symptoms of depression in 7 patients taking
tyrosine kinase inhibitors (TKIs),(5 imatinib, 2 dasatinib)
Block J. et al. J Clin Oncol 2009, 27:312-313
The European Group for Blood and Marrow Transplantation
Depression
In reporting their findings the Dana Farber team noted:
“All were coping well with their disease psychologically before
imatinib / dasatinib therapy, yet developed profound depression
during treatment, with many experiencing complete remission or
improvement of symptoms after dose reduction or drug
discontinuation.
3 patients demonstrated significant suicidal ideation
(thoughts about suicide) - a psychiatric emergency.
Interestingly, 2 patients had relapse of depression after TKI
re-challenge.”
Block J. et al. J Clin Oncol 2009, 27:312-313
The European Group for Blood and Marrow Transplantation
Depression
The authors went on to recommend:
“That patients treated with TKI, especially imatinib and dasatinib,
should receive routine screening for depressive symptoms and
suicidal ideation. Given the known elevated risk of suicide in
cancer patients, suicidal ideation should be treated as a
psychiatric emergency, with immediate referral to a psychiatrist
for assessment. Although in our clinical experience we have only
noted TKI-associated depression in patients treated with imatinib
and dasatinib, it is not inconceivable that similar adverse effects
may be seen with other TKIs, given that they share common
mechanisms of activity and have overlapping molecular targets.”
Block J. et al. J Clin Oncol 2009, 27:312-313
The European Group for Blood and Marrow Transplantation
Commonly asked questions
• Would I get a better outcome taking nilotinib and dasatinib
first line instead of imatinib?
• How long will I need to go on taking drugs for?
• Why me?
• Is there anything that I did to increase my risk of CML?
• Can I take drug holidays?
• Is CML hereditary?
• Are my children at increased risk of CML?
The European Group for Blood and Marrow Transplantation
Commonly asked questions
• What should I tell my employer?
• Am I at increased risk of developing other cancers?
• When should I contact my doctor?
• Will CML influence my life span?
• Will my fertility be affected by treatment?
The European Group for Blood and Marrow Transplantation
Commonly asked questions
• Can I start a family?
• Can I try some alternative medicines?
• Should I consider entering a clinical trial?
• Can I travel abroad for holidays?
• Am I still eligible to apply for a mortgage / health insurance?
The European Group for Blood and Marrow Transplantation
New Developments in
CML Treatment
• New compounds developed against T315I
mutations
• Combination treatments
• Vaccine strategies
The European Group for Blood and Marrow Transplantation
Compounds active against
T315I mutations
Ponatinib study:
• A total of 67 patients with various refractory hematologic
malignancies including Philadelphia chromosome-positive
(Ph+) CML were enrolled in the study to receive a daily oral
dose of ponatinib
• A large majority of patients with Ph+ CML had previously
failed treatment with other BCR-ABL inhibitors
(imatinib: 96 %, dasatinib 89 %, nilotinib: 55%)
Cortes J. et al. ASH 2010, abstract 2010
The European Group for Blood and Marrow Transplantation
Compounds active against
T315I mutations
Ponatinib study:
• 72 % of all patients enrolled in the study had BCR-ABL mutations,
with 38 % having a T315I mutation and 12 % having an F317L mutation
• Of 11 evaluable patients with CML in chronic phase with a T315I mutation,
11 patients (100 %) achieved a complete hematologic response and 9
patients (82 %) a major cytogenetic response (8 had a complete cytogenetic
response)
• Of 9 patients with CML in accelerated or blast phase or patients with T315I
mutation, 3 patients (33 %) had a major hematologic response,
and 2 (20 %) had a major cytogenetic response
Cortes J. ASH 2010, abstract 2010
The European Group for Blood and Marrow Transplantation
Compounds active against
T315I mutations
Omacetaxine study:
• Omacetaxine has a novel mechanism of action,
specifically binding to the ribosomal A-site cleft and
inhibiting protein translation of short-lived oncoproteins
that are up-regulated in leukemic cells
• Administered by subcutaneous injection
The European Group for Blood and Marrow Transplantation
Compounds active against
T315I mutations
Omacetaxine study:
Data were presented from 170 patients: 93 in chronic phase, 42 in
accelerated phase and 35 in blast phase.
Conclusions from the analysis were:
The primary toxicity of omacetaxine is hematologic, with infrequent
grade 3/4 non-hematologic events experienced; Grade 3/4 hematologic
adverse events were manageable and decreased in frequency and
severity with dose adjustments; and, injection site reactions were
primarily grade 1/2 events, demonstrating that at-home subcutaneous
administration of omacetaxine has an acceptable safety profile for CML
patients who have failed prior therapies.
Lipton J.H. ASCO 2010. Abstract no 6568
The European Group for Blood and Marrow Transplantation
Combination treatments
• Combining imatinib with previous standards
of therapy for CML such as interferon and
Ara-C can result in improvements in
outcomes
The European Group for Blood and Marrow Transplantation
Combination treatments
French SPIRIT Trial
• 695 newly diagnosed CML patients randomised to 4 treatment
arms: imatinib-400mg, imatinib-600mg, imatinib-400+araC,
and imatinib+PegIFN
Results at 18 months follow up:
• 62% of patients in the imatinib+IFN group achieved an optimal
molecular response versus 41% of imatinib-400mg patients
(P=0.0001)
The European Group for Blood
and Marrow Transplantation
Data from Guilhot F, et al. Blood. 2009, 114:144. Abstract 340
Vaccination
• There are suggestions that vaccines made from leukaemia
cells may be able to eliminate the last remaining CML
cancer cells
• In a pilot study a vaccine made from CML cells irradiated to
halt their cancerous potential was given to 19 CML patients
with measurable PH+ cells despite imatinib treatment for
one year
The European Group for Blood and Marrow Transplantation
Vaccination
Results:
• After a median of 72 months follow-up, the number of
remaining cancer cells declined in 13 patients, 12 of
whom reached their lowest levels of residual cancer
cells
• In 7 patients, CML became completely undetectable
B Douglas Smith et al. Clinical Cancer Research 2010, 16: 338-347
The European Group for Blood and Marrow Transplantation
Nursing Take Home Messages
• Keeping patients informed about new treatments /
research provides them with hope that they may one
day be able to stop treatment
• Knowing about the latest research can help to improve
patient drug compliance and provide greater insights
into their condition
The European Group for Blood and Marrow Transplantation
About the CML Advocates
Network founded in 2007
Main objectives:
• Provide public directory of CML groups
• Facilitate communication of patient representatives
• Build advocacy knowledge
Membership:
• 64 CML patient groups from 51 countries on all continents
• Strongly interacting community
The European Group for Blood and Marrow Transplantation
European CML patient groups
http://www.cmladvocates.net/members
The European Group for Blood and Marrow Transplantation
Further reading for patients
• Medifocus Guidebook on Chronic Myelogenous Leukemia
Updated: November 19, 2010,126 Pages
Provides an intelligent patient’s overview
www.medifocus.com
• "The CML Advocates Network provides a patient-friendly
summary of the Treatment recommendations
by the European Leukemia Network (ELN)”
http://cmladvocates.net/cmlsummary
• The Leukemia & Lymphoma Society in the US provides free information
booklets “The CML Guide” for patients and care givers
www.lls.org/freematerials
The European Group for Blood and Marrow Transplantation
Acknowledgements
The Nurses Group of the European Group for Blood and Marrow Transplantation gratefully
acknowledges the following individuals for their critical review and contributions to this
CML Learning Programme:
Erik Aerts (RN) Switzerland
Joanne Bell (RN) United Kingdom
Janet Fricker (Medical Writer) United Kingdom
Jan Geissler (CML AdvocatesNetwork)Germany
Andreas Himmelmann (MD) Switzerland
Katy Knight (RN) United Kingdom
Arno Mank (RN) The Netherlands
Nicole Nievergelt, (Secretary) Switzerland
Josien Regelink (MD) The Netherlands
Sebastien Ruch, Switzerland
Thorunn Saevarsdottir (RN) Iceland
Meinolf Suttorp (MD) Germany
Sarah Watmough (RN) United Kingdom
The European Group for Blood and Marrow Transplantation
The End
This CML Learning Programme was supported by Novartis
Date of preparation: 03.2012
Copyright® 2012
European Group for Blood and Marrow Transplantation
All rights reserved
The European Group for Blood and Marrow Transplantation