Breast Cancer Clinical Trial

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

Summary

The purpose of this study is to test, customize, and personalize a mobile app-based intervention program in order to help rare and breast cancer survivors cope with fears of cancer recurrence.

View Eligibility Criteria

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
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, Part 3:

Hx of early-stage breast cancer (DCIS and Stages I, II, and III) with no history of metastasis as per EMR, by self-report, or by outside correspondence.
Completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen, or on maintenance medication) as per the EMR or self-report.
Age 18 or older as per the EMR or self-report.
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) as per self-report.
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 the EMR or by self-report or by outside correspondence including a study checklist signed by a physician for patients outside of MSK
Must reside in the United States.

Phase 4, Parts 2 and 3:

Hx of early stage (Stages 0, I, II, and III) rare melanoma subtypes (e.g., acral, uveal) and skin (excluding keratinocyte cancers, e.g., basal and squamous cell), gynecological, long-term adult, pediatric rare liquid cancer (in remission only) or other rare cancer per the EMR, by self-report, or by outside correspondence.
Age 18 or older, as per the EMR or self-report.
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) as per self-report.
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 the EMR or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK
Completed active treatment (can be on hormonal therapy or on maintenance medication) as per the EMR or self-report.
Must reside in the United States.

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 EMR, by self-report, or by outside correspondence
Significant psychiatric or cognitive disturbance sufficient, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment) as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence
Current participation in cognitive-behavioral therapy (CBT), as confirmed by either self-report* or the EMR, 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
Metastatic disease
Score of
Phase 4:

Metastatic disease as per the EMR or self-report.

Score of ≤ 2 SDs below mean of the Neuro-QoL- Short Form or other indicators of significant cognitive impairment or 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 and/or EEG as part of Phase 4, Part 3 study activities. Those who decline completion of these assessments will still be eligible to participate in the study.

Study is for people with:

Breast Cancer

Estimated Enrollment:

267

Study ID:

NCT01517945

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Christian Nelson, PhD
Contact
646-888-0030
William Breitbart, MD
Contact
646-888-0020
Christian Nelson, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

267

Study ID:

NCT01517945

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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