Description:
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.
Title
- Brief Title: Adolescent and Young Adult Survivor Transition
- Official Title: Adolescent and Young Adult Survivor Transition (AYAST)
Clinical Trial IDs
- ORG STUDY ID:
CASE8Z16
- NCT ID:
NCT02948712
Conditions
- Adolescent and Young Adult Cancer
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
Eligibility Criteria
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
| Maximum Eligible Age: | 30 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Decrease in distress score according to National Comprehensive Cancer Network (NCCN) Guidelines V 1.0.2016 |
| Time Frame: | Up to 15 months after initial visit |
| Safety Issue: | |
| Description: | 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) |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Case Comprehensive Cancer Center |
Trial Keywords
- distress
- survivorship
- transition period
Last Updated
April 8, 2021
