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Behavioral Symptom Management for Young Adult Cancer Survivors

N/A

Waitlist Available

Led By Caroline S Dorfman

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with hematologic, breast, gastrointestinal, or endocrine cancers, melanoma, or germ cell tumors

Aged 18-39

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and again 3, 6, 9, and 12 months following the baseline assessment

Awards & highlights

Study Summary

This trial is testing a new way to help young adults who have survived cancer manage their symptoms and improve their quality of life.

Who is the study for?

This trial is for young adult cancer survivors aged 18-39 who were diagnosed with specific cancers like hematologic, breast, gastrointestinal, endocrine cancers, melanoma or germ cell tumors. Participants must have completed curative treatment within the last five years and be under care at Duke Cancer Institute. They should be able to speak English and give informed consent. Those with major mental illnesses or living over 100 miles from the site cannot join.Check my eligibility

What is being tested?

The study is testing a new way to help young adult cancer survivors manage symptoms that affect their daily lives and ability to follow up on care after treatment. It's a hybrid program combining in-person sessions with mobile health (mHealth) technology designed specifically for their age group's needs.See study design

What are the potential side effects?

Since this intervention involves behavioral symptom management rather than medication, there are no direct medical side effects expected. However, participants may experience emotional discomfort when discussing personal experiences related to their cancer journey.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of cancer such as blood, breast, stomach, hormone-related cancers, skin cancer (melanoma), or germ cell tumors.

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I am between 18 and 39 years old.

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I have been diagnosed with a specific type of cancer such as blood, breast, hormone-related, stomach or intestinal cancer, skin cancer, or a germ cell tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and again 3, 6, 9, and 12 months following the baseline assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and again 3, 6, 9, and 12 months following the baseline assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and again 3, 6, 9, and 12 months following the baseline assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Anxiety: PROMIS Anxiety Short Form

Change in Depressive Symptoms: PROMIS Depression Short Form

Change in Fatigue: PROMIS Fatigue Short Form

+8 more

Secondary outcome measures

Change in Emotional Support: PROMIS Emotional Support-Short Form

Change in Informational Support: PROMIS Informational Support-Short Form

Change in Instrumental Support: PROMIS Instrumental Support-Short Form

+4 more

Other outcome measures

Change in Activity: International Physical Activity Questionnaire

Change in Activity: Stanford LCAT

Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Symptom Management for Young Adult Cancer SurvivorsExperimental Treatment1 Intervention

The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms.

Group II: Waitlist ControlActive Control1 Intervention

Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,419,949 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,547 Total Patients Enrolled

6 Trials studying Germ Cell Tumors

3,720 Patients Enrolled for Germ Cell Tumors

Caroline S DorfmanPrincipal InvestigatorDuke University

Media Library

Behavioral Symptom Management for Young Adult Cancer Survivors Clinical Trial Eligibility Overview. Trial Name: NCT04035447 — N/A

Behavioral Symptom Management for Young Adult Cancer Survivors 2023 Treatment Timeline for Medical Study. Trial Name: NCT04035447 — N/A

Germ Cell Tumors Research Study Groups: Waitlist Control, Behavioral Symptom Management for Young Adult Cancer Survivors

Germ Cell Tumors Clinical Trial 2023: Behavioral Symptom Management for Young Adult Cancer Survivors Highlights & Side Effects. Trial Name: NCT04035447 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in the trial open to adults over 20 years of age?

"According to the criteria outlined by this trial, only participants between 18 and 39 years of age are eligible. There are 362 studies available for those below the legal age and 3144 geared towards seniors above 65."

Answered by AI

Who fulfills the eligibility qualifications for this research trial?

"This clinical trial is accepting 120 young adults, aged between 18 and 39 years old with active malignancies. To be eligible they must qualify as Young Adult Cancer Survivors Participating in Intervention Development Interviews; have hematologic, breast, gastrointestinal, endocrine cancer or melanoma/germ cell tumors diagnosed during their youth; possess medical records from the Duke Cancer Institute to prove curative treatment involving multimodal therapy within the last five years; demonstrate fluency in English language speaking & reading abilities and agree to provide informed consent."

Answered by AI

How many participants have been accepted for participation in this trial?

"Affirmative. Clinicaltrials.gov's data suggests that this medical research, which was first posted on January 22nd 2020, is actively searching for subjects. In total, 120 participants need to be sourced from one centre."

Answered by AI

What are the aims of this clinical experiment?

"The primary outcome of this trial, tracked for up to 12 months after completion of the intervention, is patient satisfaction as measured by the SSTS-R. Secondary outcomes encompass group cohesion through the Group Therapy Experiences Scale (17 items rated from 1 ‘strongly agree’ to 5 ‘strongly disagree’), a decrease in social isolation with PROMIS Social Isolation Scale (6 questions ranging from 1 'never' to 5 'always'), and an increase in self-efficacy via The Self-Efficacy for Managing Chronic Disease Scale (6 ratings between 1 'not at all confident' to 10 '"

Answered by AI

Is this research trial currently accepting participants?

"Affirmative. The clinicaltrials.gov database reveals that this experiment is currently recruiting patients, having been first posted on January 22nd of 2020 and last updated on August 2nd 2022. 120 participants are being sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Symptom Management for YA Cancer Survivors

2020. "Symptom Management for YA Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04035447.

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