A Behavioral Intervention (Attention and Interpretation Modification) for the Reduction of Fear of Cancer Recurrence in Cancer Survivors

Inclusion Criteria

• PHASES 1 & 2: History (Hx) of early-stage breast cancer (ductal carcinoma in situ [DCIS] and stages I, II, and III) as recorded in the medical record at Memorial Sloan Kettering (MSK) or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK.
• PHASES 1 & 2: >= 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.
• PHASES 1 & 2: Age 18 or older.
• PHASES 1 & 2: Able to read and speak English.
• PHASES 1 & 2: An overall fear index score of >= 3.0 on the Concerns About Recurrence Scale (CARS).
• PHASES 1 & 2: 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 principal investigator (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.
• PHASES 1 & 2: If in non-cognitive-behavioral therapy (CBT) psychotherapy, stable for at least 8 weeks.
• PHASES 1 & 2: 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 Phase 2 only, did not participate in Phase 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
• PHASE 3, PART 1 AND 2: 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
• PHASE 3, PART 1 AND 2: Age 18 or older
• PHASE 3, PART 1 AND 2: 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.”
• PHASE 3, PART 1 AND 2: Score of >= 12 on the 8-item Cancer Worry Scale.
• PHASE 3, PART 1 AND 2: Score of > 2 standard deviations (SDs) below the mean on the Quality of Life in Neurological Disorders (Neuro-QOL) - Short Form.
• PHASE 3, PART 1 AND 2: Uses an iOS mobile device (may be an iPad).
• PHASE 3, PART 1 AND 2: 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 per electronic medical record (EMR), by self-report, or by outside correspondence
• PHASE 3, PART 3: Completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen, or on maintenance medication) as per the EMR or self-report
• PHASE 3, PART 3: Age 18 or older as per the EMR or self-report
• PHASE 3, PART 3: 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.”
• PHASE 3, PART 3: Score >= 9 on the 6-item Cancer Worry Scale (CWS; this score was found to be optimal to screen for high fear of cancer recurrence [FCR] across cancer types)
• PHASE 3, PART 3: Score of > 2 SDs below the mean on the Neuro-QOL - Short Form
• PHASE 3, PART 3: Uses an iOS mobile device (may be an iPad) as per self-report.
• PHASE 3, PART 3: 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
• PHASE 3, PART 3: 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, mucosal) 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, as per the EMR, by self-report, or by outside correspondence
• PHASE 4, PARTS 2 AND 3: Age 18 or older, as per the EMR or self-report
• PHASE 4, PARTS 2 AND 3: 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.”
• PHASE 4, PARTS 2 AND 3: 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)
• PHASE 4 PARTS 2 AND 3: Score of > 2 SDs below the mean on the Neuro-QOL - Short Form
• PHASE 4, PARTS 2 AND 3: Uses an iOS mobile device (may be an iPad) as per self-report.
• PHASE 4, PARTS 2 AND 3: 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
• PHASE 4, PARTS 2 AND 3: Completed active treatment (can be on hormonal therapy or on maintenance medication) as per the EMR or self-report
• PHASE 4, PARTS 2 AND 3: Must reside in the United States

Exclusion Criteria

• PHASES 1 & 2: Evidence of or treatment for a second primary cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the EMR, by self-report, or by outside correspondence
• PHASES 1 & 2: 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
• PHASES 1 & 2: Current participation in cognitive-behavioral therapy (CBT), as confirmed by either self-report or the EMR, which also targets cognitive biases.
• PHASE 3: Metastatic disease as per the EMR.
• PHASE 3: Score of =< 2 SDs below the mean on 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.
• PHASE 4: Metastatic disease as per the EMR or self-report
• PHASE 4: 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.