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临床试验/NCT06682039
NCT06682039已完成不适用

Anxiety and Negative Attentional Bias in Adolescent and Young Adult Cancer Survivors

Fred Hutchinson Cancer Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Clinic recruitment rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants will be blind to study condition.

入排标准

年龄范围
15 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Arm I (ABM)

Experimental

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

干预措施: Internet-Based Intervention (Other)

Arm I (ABM)

Experimental

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

干预措施: Interview (Other)

Arm I (ABM)

Experimental

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

干预措施: Questionnaire Administration (Other)

Arm I (ABM)

Experimental

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

干预措施: Text Message-Based Navigation Intervention (Other)

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.

干预措施: Internet-Based Intervention (Other)

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.

干预措施: Questionnaire Administration (Other)

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.

干预措施: Text Message-Based Navigation Intervention (Other)

结局指标

主要结局

Clinic recruitment rates

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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