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Behavioral Symptom Management for Young Adult Cancer Survivors

Duke Cancer Institute, Durham, NC

Targeting 10 different conditionsBehavioral Symptom Management for Young Adult Cancer SurvivorsN/AWaitlist AvailableLed by Caroline S DorfmanResearch Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

diagnosis of hematologic, breast, endocrine or gastrointestinal cancer, melanoma, or germ cell tumor

Diagnosed with cancer as a young adult

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Germ Cell Tumors
Breast Cancer
Cancer
Melanoma
Young Adults
Fatigue
Blood Cancers
Psychological Distress
Pain
Endocrine Cancer

Eligibility Criteria

Inclusion Criteria

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

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You were diagnosed with cancer when you were a young adult.

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You are unable to walk or move around on your own.

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You were diagnosed with cancer when you were a young adult.

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You were diagnosed with cancer between the ages of 18 and 39.

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You will be taking care of young adults who have had cancer and are now receiving treatment at the Duke Cancer Institute.

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You are unable to walk.

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You underwent a complex treatment involving multiple therapies to cure an illness within the past five years.

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You have finished a comprehensive treatment involving multiple modes of therapy in the past 5 years.

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You have been diagnosed with certain types of cancers such as blood, breast, stomach, hormone-related, skin, or germ cell tumors.

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You have a serious mental illness like schizophrenia.

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You have a mental health condition that is not being treated or controlled, such as bipolar disorder.

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You have a serious mental illness like schizophrenia.

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You have a mental health condition like bipolar disorder that is not being treated or managed well.

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You have been diagnosed with blood, breast, stomach, intestinal, thyroid or testicular cancers, or melanoma.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,311 Previous Clinical Trials

3,388,228 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,486 Previous Clinical Trials

41,264,751 Total Patients Enrolled

6 Trials studying Germ Cell Tumors

3,682 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 t 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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