AYAST: Adolescent and Young Adult Survivor Transition

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02948712
Collaborator
(none)
2
1
1
64.4
0

Study Details

Study Description

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
  • Behavioral: Distress Screening Thermometer
  • Behavioral: NCCN Guidelines: Distress management
N/A

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

Study Type:
Interventional
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 :
Feb 7, 2017
Actual Primary Completion Date :
Jun 22, 2022
Actual Study Completion Date :
Jun 22, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Decrease in distress score according to National Comprehensive Cancer Network (NCCN) Guidelines V 1.0.2016 [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

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • Case Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02948712
Other Study ID Numbers:
  • CASE8Z16
First Posted:
Oct 28, 2016
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
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

Study Results

No Results Posted as of Jun 30, 2022