Adolescent and Young Adult Survivor Transition

Not Applicable

Terminated

• Conditions: Adolescent and Young Adult Cancer
• Interventions: Behavioral: Distress Screening Thermometer

• Registration Number: NCT02948712
• Lead Sponsor: Case Comprehensive Cancer Center

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.

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 Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Study Start: 2017-02-07
• Status Verified: 2022-06
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Survivor Distress	Distress Screening Thermometer	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States