Adolescent and Young Adult Survivor Transition

Adolescent and Young Adult Cancer Clinical Trial

— AYAST  

Official title:

Adolescent and Young Adult Survivor Transition (AYAST)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02948712
• Other study ID #: CASE8Z16
• Status: Terminated
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: June 22, 2022

Study information

• Verified date: June 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent and Young Adult Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in distress score according to National Comprehensive Cancer Network (NCCN) Guidelines V 1.0.2016	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)	Up to 15 months after initial visit