Adolescent and Young Adult Survivor Transition

NCT02948712 | Terminated DMC

• 1 other identifier: CASE8Z16
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent and Young Adult Cancer

Keywords

distress; survivorship; transition period

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Survivor Distress

EXPERIMENTAL

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; Behavioral: NCCN Guidelines: Distress management

Interventions

Distress Screening Thermometer BEHAVIORAL

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

Survivor Distress

NCCN Guidelines: Distress management BEHAVIORAL

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

Survivor Distress

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Have not completed cancer treatment within the past three months

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Amelia Baffa, RN, MSN

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 28, 2016
• Study Start: February 7, 2017
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

US (1)