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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:January 2012
End Date:January 2020
Contact:Elizabeth Slivjak, BA
Phone:646-888-0134

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The purpose of this study is to customize and personalize an existing computer-based
intervention program in order to help breast cancer survivors cope with fears of cancer
recurrence.


Inclusion Criteria:

Phases 1 & 2:

- Breast cancer survivors

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

- ≥ 3 months post completion of breast cancer treatment (may be on hormone therapy, such
as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical
record at MSK, 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 enough in dosage and use of that
medication so as to not result in a clinically significant change as determined by the
study PI/co-PI or confirmed by reports in the medical record at MSK or by self-report
or by outside correspondence, including a study checklist signed by a physician for
patients outside of MSK

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

- Access to a computer or willingness to come to MSK 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

Phase 3:

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

- >/= 3 months post-completion of breast cancer treatment (may be on hormone therapy,
such as tamoxifen) with no history of recurrence or metastasis as confirmed by the
medical record at MSK, by self-report, or by outside correspondence

- Age 18 or older

- English fluency: self-report by subject identifying English as the preferred language
for healthcare, and self-reported degree of fluency as speaking English "Very well."

- Score of >/= 12 on the Cancer Worry Scale

- Score of >/= 2 SDs below the mean on the euro-QOL-Short Form

- Uses an iOS mobile device (may be an iPad)

- If taking medication for mood, anxiety, depression, thoughts, sensory experiences such
as hallucinations, or sleep, stable for at least 8 weeks and consistent enough in
dosage and use of that medication so as to not result in a clinically significant
change as determined by the study PI/co-PI or confirmed by reports in the medical
record at MSK or by self-report or by outside correspondence, including a study
checklist signed by a physician for patients outside of MSK.

Exclusion Criteria:

Phases 1 & 2:

- Evidence of or treatment for a second primary of cancer EXCEPT basal or squamous cell
carcinoma of the skin as confirmed by the medical record at MSK, by 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.

Phase 3:

- Evidence of or treatment for a second primary cancer EXCEPT basal or squamous cell
carcinoma of the skin as confirmed by the medical record at MSK, by self-report, or by
outside correspondence

- Recurrent or metastatic disease

- Score of significant cognitive impairment of psychiatric disturbance that, in the PI's
judgment, precludes participation; and currently receiving cognitive-behavioral
therapy.

- Participants will be invited to complete assessments of salivary cortisol as part
of Phase 2 study activities. Those who decline completion of these assessments
will still be eligible to participate in the study.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Wendy Lichtenthal, Ph.D.
Phone: 646-888-0134
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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mi
from
New York, NY
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