- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06420193
Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
May 28, 2024 updated by: Karly M Murphy, PhD, East Carolina University
Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AnneMarie Coffey
- Phone Number: 252-328-6244
- Email: coffeya23@ecu.edu
Study Contact Backup
- Name: Rachel Glock
- Email: glockr23@students.ecu.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Condition 1
Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression).
|
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.
|
Experimental: Condition 2
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).
|
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.
|
Experimental: Condition 3
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).
|
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.
|
Experimental: Condition 4
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).
|
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.
|
Experimental: Condition 5
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).
|
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.
|
Experimental: Condition 6
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).
|
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.
|
Experimental: Condition 7
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).
|
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.
|
Experimental: Condition 8
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)
|
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.
|
Experimental: Condition 9
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).
|
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.
|
Experimental: Condition 10
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).
|
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.
|
Experimental: Condition 11
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).
|
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.
|
Experimental: Condition 12
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).
|
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.
|
Experimental: Condition 13
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).
|
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.
|
Experimental: Condition 14
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).
|
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.
|
Experimental: Condition 15
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)
|
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.
|
Experimental: Condition 16
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 6
|
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.
|
Weeks 6-8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Upon enrollment of 16 participants
|
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.
|
Week 6
|
Intervention Acceptability - Quantitative
Time Frame: Week 6
|
An investigator-developed survey will be used to evaluate acceptability of the intervention.
|
Week 6
|
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.
|
Week 6
|
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.
|
Weeks 6-8
|
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.
|
Week 6
|
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.
|
Weeks 1-6
|
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.
|
Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Karly M Murphy, PhD, East Carolina University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 3, 2024
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
May 7, 2024
First Submitted That Met QC Criteria
May 16, 2024
First Posted (Actual)
May 17, 2024
Study Record Updates
Last Update Posted (Actual)
May 30, 2024
Last Update Submitted That Met QC Criteria
May 28, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-001795
- R00CA248701 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All de-identified data collected from participants in this study will be preserved and shared in alignment with best practices for open science.
Data will be submitted to Dataverse, a free NIH Generalist Repository Ecosystem Initiative (https://dataverse.org/researchers).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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