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Completed

NCT Number: NCT06420193

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

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.

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Key information

Conditions

Depression Adolescent Adult Behavior Behavioral Symptoms Cancer Neoplasms Young Adult

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27858, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Behavioral

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.

Primary outcomes

  1. Acceptability of Study Procedures - Quantitative

    Time frame: Week 6

    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.

  2. Acceptability of Study Procedures - Qualitative

    Time frame: Weeks 6-8

    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.

Secondary outcomes

  1. Study Feasibility - Recruitment Rate

    Time frame: Upon enrollment of 16 participants

    Recruitment rate will be calculated as the number of participants enrolled in the study divided by the number of participants contacted.

  2. Study Feasibility - Retention Rate

    Time frame: Week 6

    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.

  3. Intervention Acceptability - Quantitative

    Time frame: Week 6

    An investigator-developed survey will be used to evaluate acceptability of the intervention.

  4. Intervention Satisfaction - Quantitative

    Time frame: Week 6

    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.

  5. Intervention Acceptability & Satisfaction - Qualitative

    Time frame: Weeks 6-8

    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.

  6. System Usability Scale

    Time frame: Week 6

    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.

  7. Intervention Adherence

    Time frame: Weeks 1-6

    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.

  8. eHealth Engagement Scale

    Time frame: Week 6

    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.

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: ASCENT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 17, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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