Breast Cancer Survivorship Issues: Age Related Differences Funded by American Cancer Society In Coll

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Breast Cancer Survivorship Issues Age Related
DifferencesFunded by American Cancer SocietyIn
Collaboration with Eastern Cooperative Oncology
Group

• PI Victoria Champion, RN, DNS, FAAN
• Co-I George Sledge, MD
• Co-I David Cella, PhD

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Significance

• The concerns of women diagnosed with breast
  cancer before the age of 45 and their partners
  have not been well addressed.
• Women diagnosed with breast cancer at a younger
  age may have poorer long-term outcomes.
• The study investigates the quality of life
  (physical functioning, psychological functioning,
  social functioning, and spiritual functioning) of
  younger breast cancer survivors and their
  partners.

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Aim 1

• To compare breast cancer survivors who were 45 or
  younger at the time of diagnosis with two groups
  of women
• Age-matched (to younger group) well females on
  QOL (physical, psychological, social, and
  spiritual functioning), considering type of
  surgical treatment (lumpectomy vs. mastectomy),
  hormonal treatments, and time since diagnosis as
  covariates for the survivors.
• Breast cancer survivors who were age 55 to 70 at
  time of diagnosis.

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Aim 2

• To compare the partners of breast cancer
  survivors who were 45 or younger at time of
  diagnosis with two groups
• partners of breast cancer survivors who were 55
  to 70 at diagnosis, and
• partners of age-matched well females on QOL
  (physical, psychological, social, and spiritual
  functioning).

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Sample

• Patients considered for study entry will be
  selected from ECOG trials C9741, E1199, and
  E2197 (also recently included NCCTG and SWOG
  patients). In these trials patients received
  adjuvant chemotherapy for Stage I-III disease,
  using a variety of chemotherapy regimens, or
  combined chemotherapy and hormonal therapy. Women
  were selected from each trial using the following
  criteria
• Received chemotherapy at trial entry
• Three to eight years of follow-up
• Disease-free at follow-up

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Sample, cont.

• Chemotherapy regimens include anthrocyline,
  taxane, Cytoxan, Methotrexate or 5-FU based chemo
  
• (i.e. AC /- Taxol, AC TAM, AC vs., Adria and
  sequential Cytoxan and tamoxifen)

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Acquaintance Controls

• Age-matched controls and partners
• Acquaintance matching will identify control
  participants and their partners. They will be
  women aged 5 years of the younger cancer
  survivors with similar education and race.
• Matched controls will be ineligible if they have
  a history of breast cancer or are personal
  friends/relatives of the survivor.

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Framework for Predicting Quality of Life
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Study Flowchart
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Consent Procedure Done by IU

• Mail letter and brochure to interested survivors
• Call survivors to explain study and obtain verbal
  permission to send informed consent
• Eligibility /name of partners obtained
• Call partners to explain study and obtain verbal
  permission to send informed consent
• Mail informed consent (survivor and partner
  consents will be mailed separately)

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Data Collection Done by IU

• Within 7-10 days of receiving the signed informed
  consents
• Mail out questionnaires
• Acquaintance control names returned with
  completed questionnaires
• Contact survivors to schedule and conduct the
  cognitive function telephone assessment
• Contact acquaintance controls and their partners
  regarding participation interest following the
  same consent procedure as survivors

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Accrual Overview
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What have we done so far?

• Four focus groups have been conducted to test
  study questionnaires and discuss breast cancer
  experiences
• 2 groups of 7 younger survivors
• 2 groups of 5 older survivors

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Focus Group Results

• We revised study questionnaires to include the
  following
• Communication with current healthcare providers
• Current exercise and general health maintenance
• Relationship changes, especially among the
  younger survivors

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Where are we at now?

• Study questionnaires have been finalized
• Official recruitment has begun and participants
  have are currently being enrolled from IU breast
  clinics
• NCI approval has been received and ECOG sties
  will begin to refer participants within the
  coming weeks

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Differences between Younger and Older Breast
Cancer Survivors

• Younger survivors
• Have higher fear of recurrence
• Poorer communication with HCO
• Higher anxiety
• Greater scores on impact of events

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Targeted Enrollment (N1070)
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Data relationships

• Communication with HCP correlated with
• Total fear of recurrence
• Depression
• Well being
• Anxiety
• Self Efficacy

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Fear of Recurrence
Preliminary data suggests younger survivors have
significantly increased fear of recurrence
p .001
Unverzagt, F., Monahan, P., Moser, L., Zhao, Q.,
Carpenter, J., Sledge, G., Champion, V.
(Accepted). The Indiana University
Telephone-Based Assessment of Neuropsychological
Status (IU-TBANS) A new method for large scale
neuropsychological assessment. Journal of the
International Neuropsychological Society.
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Scientific AccomplishmentsTheme 3 (Diagnosis
Survivorship)
p .001
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Effect of Patient Prompt Sheet on Communication
with Physician

• Principal Investigators
• Cleveland Shields, PhD
• Victoria Champion, DNS
• George Sledge, MD
• Supported by Purdue and IU Cancer Centers Grant
• Walther Cancer Institute
• American Cancer Society

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Pilot Intervention

• Younger survivors have significantly increased
  Fear of recurrence
• Communication with oncologist significantly
  related to fear of recurrence
• Younger survivors less satisfied with
  communication with oncologists

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Aim 1

• To examine the effect of telephone coaching for
  use of a worries and concern prompt sheet during
  a physician visit versus usual care on patients
  perception of the visit.
• H1.1 Patients receiving coaching prompt sheet
  will report greater satisfaction with
  communication 1 week and 2 months after the
  physician visit versus usual care.
• H1.2 Patients receiving coaching prompt sheet
  will report greater autonomy support and patient
  involvement (HCCQ) and less health care provider
  social constraint 1 week and 2 months after the
  physician visit versus usual care.

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Aim 2

• To examine the effect of telephone coaching for
  use of a worries and concern prompt sheet during
  a physician visit versus usual care on patient
  distress.
• H2.1 Patients receiving coaching prompt sheet
  after adjusting for covariates will report lower
  state anxiety and depression 1 week and 2 months
  after the physician visit versus usual care.
• H2.2 Patients receiving coaching prompt sheet
  after adjusting for covariates will report lower
  state anxiety immediately prior to physician
  visit versus usual care.
• H2.3 Patients receiving coaching prompt sheet
  after adjusting for covariates will report
  reduced fear of recurrence 1 week and 2 months
  after the physician visit versus usual care.
• H2.4 Patients receiving coaching prompt sheet
  after adjusting for covariates will report
  greater breast cancer self-efficacy 1 week and 2
  months after the physician visit versus usual
  care.

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Aim 3

• To examine the effect of telephone coaching for
  use of a worries and concern prompt sheet versus
  usual care on physician satisfaction with the
  visit.
• H3.1 Physicians will report greater satisfaction
  immediately following the clinic visit after
  adjusting for covariates with patients in the
  intervention group versus usual care group.

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Significance

• This pilot intervention builds addresses a
  significant problem identified in the ACS
  preliminary data-fear of recurrence
• The intervention builds on current communication
  literature by providing method to coach patients
  to improve communication with their oncologists.
• Could be easily adapted to clinic or Web format

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Methods

• Eligibility-45 years or younger at breast cancer
  diagnosis, 3-8 years from initial diagnosis and
  no recurrence
• Patients will be followed by Dr. George Sledge at
  Indiana University

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Methods

• Sample size of 70
• 80 power to find a .74 SD difference between
  groups

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Pilot intervention flowsheet
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Prompt Sheet Coaching

• The coach will talk with the patient about each
  item on the sheet, asking them to rate each item,
  and encouraging them to talk about each items
  rating. The items were developed from initial
  results of our prior research (ACS Grant)
• At the end of each of the two sets of items, the
  coach will ask the patient to put into words what
  she would like to tell her oncologist about her
  worries and concerns about recurrence or other
  emotional issues that are bothering her.

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Prompt Sheet Coaching (cont.)

• The coach will input the patient items for
  discussion on the Summary Sheet and mail the
  completed form to the patient for the clinic
  visit.
• The coach will normalize these concerns, telling
  her that many cancer patients have these concerns
  and that her oncologist wants to hear about them.
  

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Patient Visit

• Patients will be instructed to take the Summary
  Talking Points Sheet to their upcoming visits
  with their oncologists.

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Data Collection

• Baseline
• Day of clinic visit-STAI
• 1 Week after intervention
• 2 months after intervention

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Measures

• Patient Satisfaction PSQ
• (Patient) Physician/Pt Communication Autonomy
  Support HCCQ
• Health Care Provider Social Constraint
• Anxiety (STAI-State)
• Depression (CESD)
• Fear of Recurrence (CARS)
• Breast Cancer Self Efficacy
• Physician Satisfaction PSQ
• (Provider) Intervention Usability
• Demographic/Disease variables
• Knowledge of Recurrence of Signs and symptoms
• Family functioning (FEIES)

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Outcomes

• 3 PhD Students using data base-ACS Scholarship,
  NIH predoctoral
• Students have received ACS scholarship and NRSA
• One masters student and one undergraduate honors
  student
• 2 faculty-communication expert and new surgeon
  are involved in team and using data to develop
  research proposals
• Pilot to test reliability between telephone and
  in-person cognitive testing
• Unverzagt, F., Monahan, P., Moser, L., Zhao, Q.,
  Carpenter, J., Sledge, G., Champion, V.
  (Accepted). The Indiana University
  Telephone-Based Assessment of Neuropsychological
  Status (IU-TBANS) A new method for large scale
  neuropsychological assessment. Journal of the
  International Neuropsychological Society.

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Questions?
Thank you