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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Brown University
Weill Medical College of Cornell University
Wake Forest School of Medicine
Mclean Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01517945
First received: January 20, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: AIM materials and assessments

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • develop and refine materials [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • estimate the feasibility and acceptability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will evaluate two versions of an 8-session AIM, one that includes threat and neutral stimuli (AIMNeutral; n=25), and one that includes threat and positive stimuli (AIM-Meaning; n=25), comparing them both to a computer placebo (CP) condition (n=25). Part 2 will allow us to assess the feasibility of the research procedures, the appropriateness of the psychological and physiological outcome measures, preliminary estimates of pre- and post-intervention effect sizes and reliable change estimates, and variables associated with any observed outcomes. This will accomplish Aims 2 and 3.

  • preliminary efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will evaluate two versions of an 8-session AIM, one that includes threat and neutral stimuli (AIMNeutral; n=25), and one that includes threat and positive stimuli (AIM-Meaning; n=25), comparing them both to a computer placebo (CP) condition (n=25). Part 2 will allow us to assess the feasibility of the research procedures, the appropriateness of the psychological and physiological outcome measures, preliminary estimates of pre- and post-intervention effect sizes and reliable change estimates, and variables associated with any observed outcomes. This will accomplish Aims 2 and 3.


Biospecimen Retention:   Samples Without DNA

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Estimated Enrollment: 85
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast cancer survivors
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.
Behavioral: AIM materials and assessments
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. Seventy-five participants will be randomized to receive either AIM-Neutral (n=25), AIMMeaning (n=25), or computer placebo (CP; n=25). 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.
Other Names:
  • In situations where there are unanticipated and unavoidable session delays, we
  • will work with the participants to ensure that all sessions are completed over
  • no more than 12 weeks A follow-up session will be scheduled 3 months as far
  • back as 2 weeks before and as far out as 6 weeks after) after the completion
  • of session 8.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer survivors will be recruited to the study. There are no physical recruitment sites outside of MSKCC. Participants may be patients who were treated at MSKCC or breast cancer survivors who were treated elsewhere and learned about the study through an advertisement. The study summary and research team contact information will be available/advertised in the community through MSKCC Connections,MSKCC Survivorship Program and the American Cancer Society website.

Criteria

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 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 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 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:

  • Current evidence of or treatment for another type 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517945

Contacts
Contact: Malwina Tuman, MS 646-888-0134
Contact: Corinne Sweeney, MA 646-888-0134

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Malwina Tuman, MS    646-888-0134      
Contact: Corinne Sweeney, MA    646-888-0134      
Principal Investigator: Wendy Lichtenthal, Ph.D.         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Brown University
Weill Medical College of Cornell University
Wake Forest School of Medicine
Mclean Hospital
Investigators
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01517945     History of Changes
Other Study ID Numbers: 11-204
Study First Received: January 20, 2012
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Survivors
Quality of Life
Questionnaire
11-204

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Breast Diseases
Disease Attributes
Neoplasms
Neoplasms by Site
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014