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Adolescent and Young Adult Survivor Transition (AYAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02948712
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 28, 2016
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to help adolescents and young adult cancer survivors address their psycho-social needs during the transitional period. The transitional period begins at completion of cancer treatment and continues throughout that first year. Patients often report this period can be difficult and distressing in many areas of life. This study will use a simple tool to measure, on a regular basis, the level of distress a young adult may be feeling. Based on this assessment additional mental health support and intervention can be recommended to help cancer survivors cope and enhance their feelings of well-being.

Condition or disease Intervention/treatment Phase
Adolescent and Young Adult Cancer Behavioral: Distress Screening Thermometer Behavioral: NCCN Guidelines: Distress management Not Applicable

Detailed Description:

Study Objective:

To establish a successful distress based intervention program for adolescent and young adult survivors in the transition period.

Study Design and Methods:

The type of design for this study is a feasibility pilot study with repeated measure, within group quantitative design. There is no randomization for this study. The patient will be assessed; at baseline, upon completion of therapy, and at regular three month intervals for the first year, for a total of five assessments. After receiving a referral a member of the AYAST team will contact the patient and set up the initial visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adolescent and Young Adult Survivor Transition (AYAST)
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : June 22, 2022
Actual Study Completion Date : June 22, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Survivor Distress
This intervention will use the NCCN Distress Screening Thermometer to score each participant on their level of distress. Depending on the score the intervention will be tailored to the participant based on the Overview of Evaluation and Treatment Schema DIS-4 per the NCCN Distress Guidelines V1.0, 2016.
 Behavioral: Distress Screening Thermometer
Screening took with an overall distress ranging from 0-10 and additional stress items in the areas of practical problems, family problems, emotional problems, spiritual or religious concerns, and physical problems

Behavioral: NCCN Guidelines: Distress management
Based on the NCCN Guidelines Version 1.0.2016 which recommend brief screening, evaluation, and treatment of distress


Outcome Measures
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Primary Outcome Measures :
  1. Decrease in distress score according to National Comprehensive Cancer Network (NCCN) Guidelines V 1.0.2016 [ Time Frame: Up to 15 months after initial visit ]

    The study coordinators are using the NCCN Distress Screening Thermometer (DST) to screen patients. This includes a using the combined score of the NCCN DST and the associated problem list containing 39 items

    The NCCN Distress Thermometer consists a single-item self- report measure of psychological distress, which consists of an 11-point scale with the endpoints labeled "No distress" (0) and "Extreme distress" (10)



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed cancer treatment within the past three months of all cancer types and stages
  • Signed, written consent

Exclusion Criteria:

  • Have not completed cancer treatment within the past three months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948712


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Amelia Baffa, RN, MSN University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02948712    
Other Study ID Numbers: CASE8Z16
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
distress
survivorship
transition period