Childhood Hematopoietic and Lymphatic System Neoplasm, Childhood Malignant Solid Neoplasm
Conditions
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.
Interventions
OTHERInternet-Based Intervention
Engage in ABM + text messaging prompts
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Participants will respond to daily messaging prompts.
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants will be blind to study condition.
Eligibility
Sex/Gender
ALL
Age
15 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinic recruitment rates | Up 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 rates | Up 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 greater satisfaction(scores ≥26 indicate satisfaction). |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy Lau, PhD
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Outcome results
None listed