{ "FullStudy":{ "Rank":217702, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517945", "OrgStudyIdInfo":{ "OrgStudyId":"11-204" }, "Organization":{ "OrgFullName":"Memorial Sloan Kettering Cancer Center", "OrgClass":"OTHER" }, "BriefTitle":"Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study", "OfficialTitle":"Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study" }, "StatusModule":{ "StatusVerifiedDate":"February 2020", "OverallStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2021", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"January 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 4, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 5, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Memorial Sloan Kettering Cancer Center", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Brown University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Weill Medical College of Cornell University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Johns Hopkins University", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Mclean Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"University of Southern California", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"The New School for Social Research", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Breast Cancer" ] }, "KeywordList":{ "Keyword":[ "Survivors", "Quality of Life", "Questionnaire", "11-204" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Retrospective" ] } }, "BioSpec":{ "BioSpecRetention":"Samples Without DNA", "BioSpecDescription":"salvia" }, "EnrollmentInfo":{ "EnrollmentCount":"158", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Breast cancer survivors", "ArmGroupDescription":"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.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: AIM materials and assessments" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"AIM materials and assessments", "InterventionDescription":"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.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Breast cancer survivors" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "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." ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"develop and refine materials", "PrimaryOutcomeDescription":"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.", "PrimaryOutcomeTimeFrame":"1 year" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"estimate the feasibility and acceptability", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"preliminary efficacy", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPhases 1 & 2:\n\nBreast cancer survivors\nHx 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.\n≥ 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\nAge 18 or older\nAble to read and speak English\nAn overall fear index score of ≥ 3.0 on the CARS\nIf 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\nIf in non-CBT psychotherapy, stable for at least 8 weeks\nAccess 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.\nFor Part 2 only, did not participate in Part 1\n\nPhase 3, Part 1 and 2:\n\nHx 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\n>/= 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\nAge 18 or older\nEnglish fluency: self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English \"Very well.\"\nScore of >/= 12 on the 8-item Cancer Worry Scale\nScore of >/= 2 SDs below the mean on the euro-QOL-Short Form\nUses an iOS mobile device (may be an iPad)\nIf 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.\n\nPhase 3, Part3:\n\nHx 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, by self-report, or by outside correspondence.\n>/= 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\nAge 18 or older\nEnglish fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English \"Very well\"\nScore > 9 on the 6-item Cancer Worry Scale (CWS: this score was found to be optimal to screen for high FCR across cancer types)\nScore of > 2 SDs below the mean on the Neuro-QOL-Short Form\nUses an iOS mobile device (may be an iPad)\nIf 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\n\nExclusion Criteria:\n\nPhases 1 & 2:\n\nEvidence 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\nSignificant 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).\nCurrent participation in cognitive-behavioral therapy (CBT), as confirmed by either self-report* or the medical record which also targets cognitive biases.\n\nPhase 3:\n\nEvidence 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\nRecurrent or metastatic disease\n\nScore of