Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit

Depression Clinical Trial

— ASCENT  

Official title:

Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420193
• Other study ID #: 23-001795
• Secondary ID: R00CA248701
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: East Carolina University
• Contact: AnneMarie Coffey
• Phone: 252-328-6244
• Email: coffeya23[@]ecu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes daily mood tracking, a psychoeducational module about cancer and depression, four components that are based on evidence-based interventions for depression. The goal of this study is to evaluate the acceptability of procedures for a future trial in which the investigators will test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs. Additionally, the investigators will evaluate study feasibility as well as intervention acceptability, satisfaction, usability, and engagement.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

Inclusion Criteria:

• Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39)

• Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39)

• Time since completion of treatment: 1 month to 5 years

• Language: Fluent in English (spoken and written)

• Technology: Own smart phone with data plan

Exclusion Criteria:

• Mental Health: Current diagnosis of severe or persistent mental illness

• Suicidality: Severe suicidal ideation (including plan and intent)

Related Conditions & MeSH terms

• Adolescent
• Adult
• Cancer
• Depression
• Young Adult

Intervention

Behavioral:
• AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
Participants will receive access to a digital depression self-management tool (ASCENT), which aims to help AYAs manage symptoms of depression post-treatment. All users will have access to the core tool which includes daily mood tracking and a psychoeducational module about cancer and depression. Depending on assigned condition, participants will also receive access to up to 4 intervention modules which have been adapted from existing evidence-based treatments for digital delivery to AYAs through a rigorous user-centered design process. Within each module there are 6 micro-lessons that include an educational video, a real story from an AYA that demonstrates the topic, multiple choice questions that ask the participant to apply the educational information to the AYA story, open-ended questions that ask the participant to apply the educational information to their own experience, and a practice activity in which they are asked to try out a relevant skill.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
East Carolina University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Study Procedures - Quantitative	An investigator-developed survey will be used to evaluate acceptability of study procedures. Mean scale scores range from 1 to 4, with higher scores indicating greater acceptability. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.	Week 6
Primary	Acceptability of Study Procedures - Qualitative	An investigator-developed semi-structured interview will be used to evaluate acceptability of study procedures. Transcriptions of semi-structured interviews will undergo rapid qualitative analysis to characterize the reasons for sub-optimal acceptability of study procedures.	Weeks 6-8
Secondary	Study Feasibility - Recruitment Rate	Recruitment rate will be calculated as the number of participants enrolled in the study divided by the number of participants contacted.	Upon enrollment of 16 participants
Secondary	Study Feasibility - Retention Rate	Retention will be defined as the proportion of patients who provide T1 (6 week) data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.	Week 6
Secondary	Intervention Acceptability - Quantitative	An investigator-developed survey will be used to evaluate acceptability of the intervention.	Week 6
Secondary	Intervention Satisfaction - Quantitative	An investigator-developed survey will be used to evaluate satisfaction with the intervention. Mean scale scores range from 1 to 4, with higher scores indicating greater satisfaction. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.	Week 6
Secondary	Intervention Acceptability & Satisfaction - Qualitative	A semi-structured interview will be used to further characterize acceptability of and satisfaction with the intervention. Transcriptions of semi-structured interviews will undergo rapid qualitative analysis to characterize the reasons for sub-optimal acceptability of and satisfaction with the intervention.	Weeks 6-8
Secondary	System Usability Scale	The System Usability Scale (SUS) will be administered to evaluate perceived usability of ASCENT. SUS scores range from 0 to 100, with higher scores indicating greater usability. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.	Week 6
Secondary	Intervention Adherence	Adherence will be calculated as the percentage of pages viewed by the participant within a module divided by the total number of pages in the module as indicated by metrics from the website. Mean adherence rate and exact 95% confidence intervals (CIs) for each intervention module will be calculated.	Weeks 1-6
Secondary	eHealth Engagement Scale	The eHealth Engagement Scale will be administered to evaluate how engaging users found ASCENT engagement. Mean scale scores range from 1 to 4, with lower scores indicating greater engagement. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.	Week 6