Clinical trial NCT06682039: Attention Bias Modification for the Improvement of Anxiety in Adolescent and Young Adult Cancer Survivors
Official title: Anxiety and Negative Attentional Bias in Adolescent and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Hematopoietic and Lymphatic System Neoplasm
Childhood Malignant Solid Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 activity for 4 weeks.

ARM II: 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 study intervention, patients are followed up at 4 weeks. After completion of this 4 week follow up survey, patients are given access to all components of ABM and texts on study.

Eligibility criteria: 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

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

Primary outcomes:
measure: Clinic recruitment rates
timeFrame: Up to 4 weeks post-intervention
measure: Retention rates
timeFrame: Up to 4 weeks post-intervention
measure: Patient acceptability of ABM: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At 4 weeks post intervention
measure: Patient acceptability of ABM: System Usability Scale (SUS)
timeFrame: At 4 weeks post intervention
Secondary outcomes:
Other outcomes:
measure: Change in Health-Related Quality of Life from Baseline to Post-treatment as Assessed by PROMIS Profile-57
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Resilience from Baseline to Post-treatment as Assessed by CD-RISC-10
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Psychological Distress from Baseline to Post-treatment as Assessed by Kessler-6
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Anxiety and Depression Symptoms from Baseline to Post-treatment as Assessed by HADS-6
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Health Anxiety from Baseline to Post-treatment as Assessed by SHAI
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Fear of Cancer Recurrence from Baseline to Post-treatment as Assessed by FCRI-SF
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Experience of Attention Bias from Baseline to Post-treatment as Assessed by ABQ
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Pain Intensity from Baseline to Post-treatment as Assessed by PROMIS Pain Intensity
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Pain Frequency, Intensity, and Interference from Baseline to Post-treatment
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Pain-related Activity Limitations from Baseline to Post-treatment as Assessed by CALI-9
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Overall Sleep Quality Score from Baseline to Post-treatment as Assessed by ASWS-SF
timeFrame: From baseline to post-treatment (4 weeks)
measure: Change in Insomnia Symptoms from Baseline to Post-treatment as Assessed by AIQ
timeFrame: From baseline to post-treatment (4 weeks)
measure: Cognitive Function from Baseline to Post-treatment as Assessed by PROMIS NeuroQOL
timeFrame: Baseline
measure: Change in Attention Bias Scores from Baseline to Post-treatment as Assessed by Dot Probe Task
timeFrame: From baseline to post-treatment (4 weeks)
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
name: Nancy Lau, PhD
role: PRINCIPAL_INVESTIGATOR
References: