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Guided Imagery for Head and Neck Cancer
N/A
Waitlist Available
Led By Elissa Kolva
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 - 100
Confirmed malignancy of the head and neck region (including metastases from other primary tumors and cancers of unknown primary)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to one month post-radiotherapy, up to 12 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if using guided imagery can help reduce anxiety and depression in head and neck cancer patients undergoing radiotherapy.
Who is the study for?
This trial is for adults aged 18-100 with confirmed head and neck cancer, including metastases from other tumors. Participants must be able to read and communicate in English, have no unmanaged psychiatric symptoms or dementia, and be starting radiotherapy at the University of Colorado Cancer Center. They need internet or phone access for remote meetings.
What is being tested?
The study tests whether guided imagery can help reduce anxiety and depression related to radiotherapy in patients with head and neck cancers compared to usual treatment without this intervention. It's a pilot study focusing on feasibility, acceptability, and initial effectiveness.
What are the potential side effects?
Since the intervention involves guided imagery—a relaxation technique—side effects are minimal but may include discomfort or emotional distress if participants find revisiting certain thoughts challenging during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 100 years old.
Select...
My cancer is in the head or neck area, or it spread there from another place.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to one month post-radiotherapy.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to one month post-radiotherapy.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Secondary study objectives
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score
Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score
The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]
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: Guided ImageryExperimental Treatment1 Intervention
The GI intervention will include direct, written, and audio delivery of one of three GI vignettes (depiction).The patient will be able to choose one of the three vignettes.
Group II: Treatment as UsualActive Control1 Intervention
The control, or treatment as usual condition, will include an orientation to radiotherapy from the clinic nurse coordinator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guided Imagery
2010
N/A
~960
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,820 Total Patients Enrolled
Elissa KolvaPrincipal InvestigatorUniversity of Colorado, Denver
Jamie StudtsPrincipal InvestigatorUniversity of Colorado, Denver
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