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

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ClinicalTrials.gov Identifier: NCT01517945
Recruitment Status : Recruiting
First Posted : January 25, 2012
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
Brown University
Weill Medical College of Cornell University
Johns Hopkins University
Mclean Hospital
University of Southern California
The New School for Social Research
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date January 20, 2012
First Posted Date January 25, 2012
Last Update Posted Date June 5, 2019
Study Start Date January 2012
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2012)
develop and refine materials [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01517945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 11, 2015)
  • estimate the feasibility and acceptability [ Time Frame: 1 year ]
    We will evaluate two versions of an 8-session AIM, one that includes threat and neutral stimuli (AIMNeutral; n=37), and one that includes threat and positive stimuli (AIM-Meaning; n=37), comparing them both to a computer placebo (CP) condition (n=37). 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 ]
    We will evaluate two versions of an 8-session AIM, one that includes threat and neutral stimuli (AIMNeutral; n=37), and one that includes threat and positive stimuli (AIM-Meaning; n=37), comparing them both to a computer placebo (CP) condition (n=37). 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.
Original Secondary Outcome Measures
 (submitted: January 20, 2012)
  • estimate the feasibility and acceptability [ Time Frame: 1 year ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study
Official Title Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
salvia
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.
Condition Breast Cancer
Intervention 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. 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.
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.
Study Groups/Cohorts 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.
Intervention: Behavioral: AIM materials and assessments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 17, 2018)
158
Original Estimated Enrollment
 (submitted: January 20, 2012)
85
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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, Part 1 and 2:

  • 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 8-item 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.

Phase 3, Part3:

  • 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 a 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 > 9 on the 6-item Cancer Worry Scale (CWS: this score was found to be optimal to screen for high FCR across cancer types)
  • Score of > 2 SDs below the mean on the Neuro-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 </= SDs below the mean on the Neuro-QOL-Short Form or other indicators 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wendy Lichtenthal, PhD 646-888-4812 lichtenw@mskcc.org
Contact: William Breitbart, MD 646-888-0020
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01517945
Other Study ID Numbers 11-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators
  • Brown University
  • Weill Medical College of Cornell University
  • Johns Hopkins University
  • Mclean Hospital
  • University of Southern California
  • The New School for Social Research
Investigators
Principal Investigator: Wendy Lichtenthal, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date June 2019