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Symptom Management Intervention for Advanced Cancer in AYAs
N/A
Recruiting
Led By Caroline S Dorfman, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all rct participants: 12 months following the start of study enrollment
Awards & highlights
Study Summary
This trial will study the feasibility & acceptability of a psychosocial symptom management intervention for AYAs with advanced cancer. It will combine traditional & modern approaches to address physical & psychological symptoms, symptom interference, self-efficacy & values.
Who is the study for?
This trial is for young people aged 15-29 with advanced cancer that can't be cured or has spread far (metastases). Participants must speak and read English, but those with severe mental illnesses like schizophrenia or significant visual, hearing, or cognitive impairments cannot join.Check my eligibility
What is being tested?
The study tests a psychosocial intervention called SMILE designed for these young adults. It combines behavioral strategies from palliative care with Meaning-Centered Psychotherapy and Acceptance and Commitment Therapy over videoconferencing in four weekly sessions.See study design
What are the potential side effects?
Since this is a psychological support intervention rather than a drug treatment, traditional side effects are not expected. However, discussing emotional topics could potentially cause temporary distress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all rct participants: 12 months following the start of study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all rct participants: 12 months following the start of study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Acceptance and Action
Change in Anxiety Symptoms
Depressive Symptoms
+10 moreOther outcome measures
Opinion of the Intervention
Trial Design
2Treatment groups
Experimental Treatment
Group I: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Experimental Treatment1 Intervention
Four, 60-minute sessions will provide training on behavioral symptom management skills, delivered over 6-8 weeks to patients in their homes using videoconferencing.
Group II: Education Control ArmExperimental Treatment1 Intervention
The control arm will receive the NCI booklet, "Taking Time: Support for People with Cancer" and otherwise continue their usual care.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,865 Total Patients Enrolled
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,466 Total Patients Enrolled
Caroline S Dorfman, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a caregiver for someone with cognitive impairment.I have hearing loss.I am between 15 and 29 years old.I am a caregiver for someone with hearing loss.I am a caregiver for someone with visual impairment.I am 18 years old or older and a caregiver.My cancer is advanced or has come back.I have trouble seeing.
Research Study Groups:
This trial has the following groups:- Group 1: Education Control Arm
- Group 2: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still enrolling participants for the trial?
"According to official records on clinicaltrials.gov, this particular trial has concluded its recruitment phase and is no longer looking for participants; the initial posting was placed November 15th 2022 with a final update occurring October 20th 2022. However, there are other medical trials currently recruiting patients at this time."
Answered by AI
Is the enrollment of seniors aged 80 and above being considered for this experiment?
"According to this medical trial's entry requirements, participants need to be between 15 and 29 years old."
Answered by AI
What demographic might be most suitable for this research trial?
"Eligible candidates for this trial should have adolescent and young adult cancer, ranging from 15 to 29 years old. This medical research is seeking approximately 40 participants."
Answered by AI
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