Attention and Interpretation Modification for Fear of Cancer Recurrence

Not currently recruiting at 1 trial location

Overseen By Christian Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Hormone therapy

Disqualifiers: Second cancer, Metastatic, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help breast and rare cancer survivors manage their fears of cancer returning. The app, which includes AIM materials and assessments, serves as a personalized tool for individuals who have completed treatment and worry about recurrence. The trial seeks participants who have finished treatment for early-stage breast cancer or a rare cancer and currently experience significant worry about recurrence. Participants should be comfortable using an iOS device and reside in the U.S. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance support tools for cancer survivors.

Do I need to stop my current medications to join the trial?

You don't need to stop your current medications, but if you're taking medication for mood, anxiety, depression, or similar issues, your dosage must be stable for at least 8 weeks before joining the trial.

What prior data suggests that this mobile app-based intervention program is safe for cancer survivors?

Research has shown that psychological treatments to manage the fear of cancer recurrence are generally safe and easy to handle. Studies have found these in-person treatments to be both feasible and beneficial for those dealing with this fear. A recent study on a similar online program, iConquerFear, found it safe and acceptable for users, with no major problems reported. This suggests that using AIM materials and assessments in a mobile app could also safely help cancer survivors manage their fears. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Attention and Interpretation Modification (AIM) intervention because it offers a fresh approach to managing fear of cancer recurrence, particularly for breast cancer survivors and those with rare cancers. Unlike traditional therapies that may focus on general psychological support, AIM specifically targets how patients interpret and respond to cancer-related thoughts, aiming to reshape negative thinking patterns. This psychosocial intervention could provide more tailored support, addressing a significant gap for rare cancer survivors who often lack resources post-treatment. By potentially reducing anxiety around cancer recurrence, AIM seeks to improve quality of life and emotional well-being for these individuals.

What evidence suggests that this mobile app-based intervention is effective for helping cancer survivors cope with fears of recurrence?

Research shows that psychological treatments can greatly reduce the fear of cancer recurrence. This trial will evaluate a psychosocial intervention specifically for breast cancer survivors and rare cancer survivors. Studies have found that both in-person and online methods effectively manage this fear. Online programs, such as the mobile app under development, have been particularly helpful for breast cancer survivors. Cognitive therapy, a type of psychological treatment, has also effectively lowered this fear. Overall, evidence suggests these treatments can help cancer survivors manage worries about the disease returning. ^{1 6 7 8 9}

Who Is on the Research Team?

Christian Nelson, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

≥ 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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and refinement of the mobile app-based intervention program targeting fear of cancer recurrence

1 year

Preliminary Efficacy Evaluation

Evaluation of three versions of the app-based intervention program to assess feasibility, appropriateness, and preliminary efficacy

1 year

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AIM materials and assessments

How Is the Trial Designed?

Group I: Breast cancer survivors and Rare cancer survivors Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

The New School for Social Research

Collaborator

Trials

9

Recruited

3,200+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6823887/

Effect of Psychological Intervention on Fear of Cancer ... Associations have been reported between FCR and depression, poorer quality of life, and impaired functioning, and a growing body of evidence ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8790693/

Remote Psychological Interventions for Fear of Cancer ... Current evidence suggests that face-to-face psychological interventions for FCR are feasible, acceptable, and efficacious for managing FCR.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0312769

Web-based interventions for fear of cancer recurrence The objective of this scoping review is to provide an overview of the available evidence on the effectiveness of web-based interventions for fear of cancer ...

4. researchgate.net researchgate.net/publication/361264669_The_effect_of_psychological_interventions_on_fear_of_cancer_recurrence_in_breast_cancer_survivors_A_systematic_review_and_meta-analysis

The effect of psychological interventions on fear of cancer ... We found psychological interventions significantly reduced fear of cancer recurrence. Subgroup analyses indicated that mindfulness and acceptance therapy‐based ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04287218

Reducing Fear of Cancer Recurrence in Danish Colorectal ... Study Overview. Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive ...

6. mdpi.com mdpi.com/2227-9032/13/17/2165

Systematic Review of Fear of Cancer Recurrence Patient ... A systematic review of 130 studies estimated that approximately 49% of cancer survivors experience moderate to high levels of FCR, with 7% reporting high to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06872840

Adapting The Fear Of Recurrence Therapy (FORT) for ... Clinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater levels of FCR, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9321869/

What is the prevalence of fear of cancer recurrence in ... The combined mean FCR score was 16.1 (14.4–17.7), compared with 14.3 for survivors and 16.2 for patients in the IPD analysis.

9. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13639-6

Assessing the impact of a self-guided digital intervention for ... This pilot, randomised waitlist-controlled trial aimed to evaluate the feasibility, acceptability, and safety of iConquerFear, a self-guided ...