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Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study


Inclusion Criteria:



- Breast cancer survivors

- Hx of early-stage breast cancer (DCIS and Stages I and II)as recorded in the medical
record at MSKCC or by self-report or by outside correspondence, including a study
checklist signed by a physician for patients outside of MSKCC.

- >1 year from completion of cancer treatment (may be on hormone therapy, such as
tamoxifen) with no hx of recurrence or metastasis as confirmed by the medical record
at MSKCC or self- report or by outside correspondence

- Age 18 or older

- Able to read and speak English

- An overall fear index score of > 3.0 on the CARS

- If taking medication for mood, anxiety, depression, thoughts, sensory experiences
such as hallucinations, or sleep, stable and consistent in dosage and use of that
medication for at least 8 weeks, as confirmed by reports in the medical record at
MSKCC or by self-report or by outside correspondence, including a study checklist
signed by a physician for patients outside of MSKCC

- If in non-CBT psychotherapy, stable for at least 8 weeks

- Access to a computer or willingness to come to MSKCC or Weill Cornell to complete
intervention sessions 2-8 and the 3-month follow-up assessment, if no personal
computer.

- For Part 2 only, did not participate in Part 1

Exclusion Criteria:

- Evidence of other type of cancer (current diagnosis or history of
recurrence/metastasis) EXCEPT basal or squamous cell carcinoma of the skin as
confirmed by the medical record at MSKCC or self- report or by outside correspondence

- Significant psychiatric or cognitive disturbance sufficient, in the investigator's
judgment, to preclude providing informed consent or participating in the
interventions (i.e., acute psychiatric symptoms which require individual treatment).

- Current participation in cognitive-behavioral therapy (CBT), as confirmed by either
self-report* or the medical record which also targets cognitive biases. Participants
may continue non-CBT psychotherapy and may remain on psychotropic medications as long
as their dose has been stable for 8 weeks prior to consent and remains stable during
the study period.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

develop and refine materials

Outcome Description:

for AIM-Neutral and AIM-Meaning. This will involve development of AIM materials and assessments (based on the preliminary work conducted by Beard et al.70-73) that target fear of cancer recurrence through feedback from BCS (n=10). It will also involve training of the research staff in the assessments and AIM. This will accomplish Primary Aim 1.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Wendy Lichtenthal, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-204

NCT ID:

NCT01517945

Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • Survivors
  • Quality of Life
  • Questionnaire
  • 11-204
  • Breast Neoplasms
  • Recurrence

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021