This trial is active, not recruiting.

Condition breast cancer
Treatment aim materials and assessments
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Brown University
Start date January 2012
End date January 2017
Trial size 127 participants
Trial identifier NCT01517945, 11-204


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
This is a Center for Translational Science Center (CTSC)-funded intervention development and pilot clinical trial of a psychosocial intervention to address fear of cancer recurrence in breast cancer survivors (BCS). BCS form the largest survivor cohort of any cancer, with approximately 2.5 million living in the United States.
aim materials and assessments In situations where there are unanticipated and unavoidable session delays, we
Part 1 will be used to develop & refine the intervention & assessment materials with 10 participants. We will adapt two previously validated CBM tasks, attention modification & interpretation modification to create two novel AIM programs (designated AIM-Neutral & AIM-Meaning), each of which targets both attention & interpretation biases for fear of breast cancer recurrence. Participants will complete the assessment battery & 1 30-minute session of each version of the intervention (AIM-Neutral & AIM-Meaning) & will provide feedback about the recruitment procedures, stimuli, & assessments. Part 2 will be a proof-of-concept, small scale, single-blind, placebo-controlled RCT of AIM. One hundred eleven participants will be randomized to receive either AIM-Neutral (n=37), AIM-Meaning (n=37), or computer placebo (CP; n=37). The AIM & CP conditions will involve completion of 8 30-minute sessions Participants will be instructed to complete 2 sessions per week for a total of 4 weeks.

Primary Outcomes

develop and refine materials
time frame: 1 year

Secondary Outcomes

estimate the feasibility and acceptability
time frame: 1 year
preliminary efficacy
time frame: 1 year

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Breast cancer survivors - Hx of early-stage breast cancer (DCIS and Stages I, II and III)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. - ≥ 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 MSKCC, 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 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 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 or treatment for a second primary of cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the medical record at MSKCC, 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.

Additional Information

Official title Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study
Principal investigator Wendy Lichtenthal, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.