N/A
Completed N=57
Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer
Source: ClinicalTrials.gov NCT03662698 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Aug 2024
Primary outcomePrimary: The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility] — 19; 25 Participants
Summary
The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility] |
4; 10; 9; 11; 13; 9 | — |
| PRIMARY The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability] |
19; 0; 17; 2 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score |
1.93; -0.05 | — |
| SECONDARY Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score |
-0.08; -0.11 | — |
| SECONDARY The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact] |
-16.54; -14.9 | — |
Eligibility Criteria
Inclusion Criteria
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be aged 18 - 100.
- Ability to read and communicate in English.
- A confirmed malignancy of the head and neck region (including metastases from other primary tumors and cancers of unknown primary.
- Initiation of RT at the University of Colorado Cancer Center.
- Psychiatric and cognitive stability as assessed by chart review (i.e., no documented dementia diagnosis or unmanaged psychiatric symptoms) and study personnel (i.e., ability to attend to meeting with study personnel).
- Ability to meet remotely via internet connection or over the phone.
Exclusion Criteria
- Any individual who does not meet the inclusion criteria.
- Those who are determined, by mental health professionals, to be psychiatrically unstable.
Data sourced from ClinicalTrials.gov (NCT03662698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.