Clinical trial NCT01517945: Attention and Interpretation Modification (AIM) for Fear of Cancer Recurrence: An Intervention Development Study
Official title: Attention and Interpretation Modification (AIM) for Fear of Cancer Recurrence: An Intervention Development Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Rare Cancer
Keywords: Survivors
Quality of Life
Questionnaire
11-204
Rare Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Brown University
name: Weill Medical College of Cornell University
name: Johns Hopkins University
name: Mclean Hospital
name: University of Southern California
name: The New School for Social Research
First posted: 2012-01-25
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rare and 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 rare 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.

Brief 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.


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 \</= 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.

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.

Primary outcomes:
measure: Develop and refine materials (iThrive and iTrack)
timeFrame: 1 year
Secondary outcomes:
measure: Determine feasibility, usability, acceptability
timeFrame: 1 year
measure: Preliminary Efficacy
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: