Adolescent and Young Adult Survivor Transition (AYAST)

Adolescent and Young Adult Survivor Transition (AYAST)

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.

Study Overview

• Status: Terminated
• Conditions: Adolescent and Young Adult Cancer
• Intervention / Treatment: Behavioral: Distress Screening Thermometer; Behavioral: NCCN Guidelines: Distress management

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Amelia Baffa, RN, MSN, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: survivorship; distress; transition period
• Other Study ID Numbers: CASE8Z16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No