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

University of North Carolina System

Status: Enrolling

Conditions: Adult; Young Adult; Adolescent; Cancer; Depression

Treatments: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06420193

R00CA248701 (U.S. NIH Grant/Contract)

23-001795

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 15 to 39 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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16 participants in 16 patient groups

Condition 1

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 2

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 3

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 4

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 5

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 6

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 7

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 8

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 9

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 10

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 11

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 12

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 13

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 14

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 15

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance)

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Condition 16

Experimental group

Description:

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); and Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)

Treatment:

Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)