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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Rare Cancer
• Intervention / Treatment: Behavioral: AIM materials and assessments

• Study Type: Observational
• Enrollment (Estimated): 267

Contacts and Locations

• Study Contact: Name: Christian Nelson, PhD; Phone Number: 646-888-0030; Email: nelsonc@MSKCC.ORG
• Study Contact Backup: Name: William Breitbart, MD; Phone Number: 646-888-0020

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: William Breitbart, MD; Phone Number: 646-888-0020
      • Contact: Christian Nelson, PhD; Phone Number: 646-888-0030
      • Principal Investigator: Christian Nelson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Breast cancer survivors and Rare cancer survivors; This is a Cycle for Survival and 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) and rare cancer survivors (RCS). BCS form the largest survivor cohort of any cancer, with approximately 2.5 million living in the United States. About 50 percent of people with cancer have a rare cancer. Even though they account for about half of all cancer diagnoses when combined, research aimed at supporting RCS is sparse, leaving RCS with limited support after treatment.

Behavioral: AIM materials and assessments; Phase 1 (complete) - dev of AIM materials targeting fear of cancer recurrence in BCS (n = 10). Phase 2 (complete) - randomized, single-blind, placebo-controlled, proof-of-concept pilot trial. Phase 3: Part 1 of Phase 3 (complete) - dev of of iThrive app for BCS; Part 2 of Phase 3 (complete) - usability testing by observing navigation with BCS in a laboratory setting; Part 3 of Phase 3 - acceptability of iThrive will be assessed through a small RCT (n=30) Phase 4: Part 1 of Phase 4 (complete) - dev of iThrive app for RCS; Part 2 of Phase 4 (complete) - usability testing completed by observing navigation with RCS remotely; Part 3 of Phase 4 - acceptability of iThrive will be assessed through a small RCT (n=90) For Phases 3 and 4, Part 3: We will work with participants to ensure that sessions are completed over < 12 weeks if unavoidable delays occur. A follow-up session will be scheduled 3 months after completion of the last session.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop and refine materials (iThrive and iTrack)	This will involve development of a mobile app-based intervention program (based on our results from Phase 1 and 2 and preliminary work conducted by Beard et al.) that targets fear of cancer recurrence for breast, rare gynecological, rare melanoma and skin, long-term adult pediatric, and other rare cancer survivors.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine feasibility, usability, acceptability	We will evaluate three versions of the app-based intervention program (iThrive 8, iThrive 16, and iTrack) in BCS (n=30) and RCS (n=90). This 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.	1 year
Preliminary Efficacy	We will evaluate three versions of the app-based intervention program (iThrive 8, iThrive 16, and iTrack) in BCS (n=30) and RCS (n=90). This 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.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Johns Hopkins University; Brown University; University of Southern California; Weill Medical College of Cornell University; Mclean Hospital; The New School for Social Research
• Investigators: Principal Investigator: Christian Nelson, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 20, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimated): January 25, 2012

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Questionnaire; Survivors; Rare Cancer; 11-204
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 11-204