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

NCT01517945 | Active Not Recruiting DMC

• 1 other identifier: 11-204
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Rare Cancer

Keywords

Survivors; Quality of Life; Questionnaire; 11-204; Rare Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine feasibility, usability, acceptability

  1 year

• Preliminary Efficacy

  1 year

Study Arms (1)

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

Interventions

AIM materials and assessments BEHAVIORAL

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.

Also known as: 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.

Breast cancer survivors and Rare cancer survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Brown University: collaborator
• Johns Hopkins University: collaborator
• Mclean Hospital: collaborator
• University of Southern California: collaborator
• The New School for Social Research: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

salvia

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lead

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Rebecca Saracino, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)