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

Registration Number
NCT06682039
Lead Sponsor
Fred Hutchinson Cancer Center
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, distres...

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients engage in ABM over 10 minutes twice a week (BIW) and respond daily to text messaging prompts to complete gratitude/savoring activity for 4 weeks.
...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Age 15-29 years
  • Diagnosis of cancer malignancy
  • Received active/curative cancer treatment 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Clinic recruitment ratesUp to 4 weeks post-intervention

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.

Retention ratesUp to 4 weeks post-intervention

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.

Patient acceptability of ABM: Client Satisfaction Questionnaire (CSQ-8)At 4 weeks post intervention

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 grea...

Patient acceptability of ABM: System Usability Scale (SUS)At 4 weeks post intervention

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

🇺🇸

Seattle, Washington, United States

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