Attention Bias Modification for the Improvement of Anxiety in Adolescent and Young Adult Cancer Survivors

NCT06682039 | Completed

• 4 other identifiers: RG1124389NCI-2024-06745P30CA015704STUDY00004811
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies how well attention bias modification (ABM) improves anxiety in adolescent and young adult (AYA) cancer survivors. Cancer-related anxiety is the most prevalent mental health problem affecting AYA cancer survivors. Cancer-related anxiety is associated with long-term negative outcomes such as poor quality of life, depression, distress, substance use, sleep problems, fatigue, and pain. ABM uses techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. ABM uses brief self-guided smartphone applications. Patients complete repetitive association reaction-time tasks targeting automatic and unconscious negative attention biases to retrain attention away from perceived threat and towards a neutral or positive stimuli. Gratitude-finding and savoring activities are also provided to maintain and increase positive emotions. Using ABM plus gratitude-finding and savoring activities may improve anxiety in AYA cancer survivors.

Conditions

Childhood Hematopoietic and Lymphatic System Neoplasm; Childhood Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• Clinic recruitment rates

  Feasibility will be assessed via clinic recruitment rates, defined as (number \[#\] of adolescent and young adults \[AYAs\] who enroll in the study) / (total # of AYAs screened as eligible). Attention bias modification (ABM) will be considered feasible with ≥ 50% enrollment.

  Up to 4 weeks post-intervention

• Retention rates

  Uptake will be assessed via retention rates, defined as (# of AYAs who complete 4-week treatment duration of ABM) / (# of AYAs who enroll in the study). ABM will be considered feasible with ≥ 70% retention.

  Up to 4 weeks post-intervention

• Patient acceptability of ABM: Client Satisfaction Questionnaire (CSQ-8)

  Will be assessed using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction(scores ≥26 indicate satisfaction).

  At 4 weeks post intervention

• Patient acceptability of ABM: System Usability Scale (SUS)

  Will be assessed using the System Usability Scale (SUS). The SUS is a well-validated and widely used 10-item scale to evaluate the perceived usability of digital interventions. Items are rated on a 5-point Likert scale for a total score ranging from 0-100, and scores ≥ 70 considered adequate usability.

  At 4 weeks post intervention

Other Outcomes (14)

• Change in Health-Related Quality of Life from Baseline to Post-treatment as Assessed by PROMIS Profile-57

  From baseline to post-treatment (4 weeks)

• Change in Resilience from Baseline to Post-treatment as Assessed by CD-RISC-10

  From baseline to post-treatment (4 weeks)

• Change in Psychological Distress from Baseline to Post-treatment as Assessed by Kessler-6

  From baseline to post-treatment (4 weeks)

Study Arms (2)

Arm I (ABM)

EXPERIMENTAL

Patients engage in ABM over 10 minutes BIW and respond daily to text messaging prompts for 4 weeks.

Other: Internet-Based Intervention; Other: Interview; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention

Arm II (inert attention task)

ACTIVE COMPARATOR

Patients engage in inert attention task sessions over 10 minutes BIW for 4 weeks. Patients also receive and respond to text messaging prompts QD for 4 weeks. After completion of the 4 week follow up survey, patients are given access to all components of ABM and texts on study.

Other: Internet-Based Intervention; Other: Questionnaire Administration; Other: Text Message-Based Navigation Intervention

Interventions

Internet-Based Intervention OTHER

Engage in ABM + text messaging prompts

Arm I (ABM)

Interview OTHER

Ancillary studies

Arm I (ABM)

Questionnaire Administration OTHER

Ancillary studies

Arm I (ABM); Arm II (inert attention task)

Text Message-Based Navigation Intervention OTHER

Participants will respond to daily messaging prompts.

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Arm I (ABM); Arm II (inert attention task)

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 15-29 years
• Diagnosis of cancer malignancy
• Received active/curative cancer treatment OR received/actively receiving cancer survivorship care at Seattle Children's Hospital (SCH) or other study referring site (e.g. St. Jude)
• Currently off active/curative cancer treatment
• Patient able to understand/read/write English language
• Cognitively able to participate in ABM intervention and complete surveys
• Patient has access to smartphone able to send and receive text messages
• Patient has access to computer or smartphone for Inquisit program

You may not qualify if:

• Patients on active/curative cancer treatment
• Cognitively or physically unable to participate in ABM intervention and surveys
• Patients who cannot understand/read/write English will be excluded from the research because the ABM intervention is currently only available in English
• Furthermore, patients who do not have access to technology (smartphone/computer) will be excluded from the study as this technology is absolutely required to engage in the study intervention

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington/Seattle Children's Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Lau N, Zhou C, Hong SJ, Aalfs H, Higgins S, Badillo I, McCauley E, Ketterl T, Chow EJ, Fann JR, Heathcote LC, Palermo TM. Digital Attention Bias in Cancer Survivors Intervention for Adolescent and Young Adult Cancer Survivors: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 25;15:e82665. doi: 10.2196/82665.

  PMID: 41740148 DERIVED

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nancy Lau, PhD

  Fred Hutch/University of Washington/Seattle Children's Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blind to study condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: November 8, 2024
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)