Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce RT-related symptoms of anxiety and depression in patients with HNC relative to treatment as usual.

Detailed Description
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The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce RT-related symptoms of anxiety and depression in patients with HNC relative to treatment as usual. Treatment as usual contains no psychological interventions to aid in distress, however participants will have access to the psychosocial supports at the cancer center available to all patients. Patients will be randomized to either condition, and surveys of their well-being will be conducted throughout the study.

Official Title
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Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Guided Imagery
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to the guided imagery intervention or to treatment as usual.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Imagery<br>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. | Behavioral: Guided Imagery<br>* GI is a relaxation technique involving the visualization of images and is considered an adjuvant cancer therapy.The GI intervention will include two hour-long meetings between the participant and a trained interventionist. The sessions will include direct, written, and audio delivery of one of three GI vignettes. The patient will be able to choose one of the three vignettes. The approximately twelve minute long vignettes included in the study will be: Taking a Walk, Healthy Cell Alliance for Treatment, and Daily Intention (32). Patients will also be given access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC.<br>|
| Active Comparator: Treatment as Usual<br>The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator. | Other: Treatment as Usual<br>* This will include a tour of the treatment room and education about RT. Patients will also receive educational materials about RT including the process of RT and CT simulation, treatment side effects, pain management, and swallowing exercises. Participants in this condition will also have access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility] | Feasibility of intervention use will be assessed through rates of study enrollment. | From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years. | 
| The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility] | Feasibility of intervention use will be assessed through rates of GI session attendance. | From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years. | 
| The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility] | Feasibility of intervention use will be assessed through self-reported use of the GI intervention measured through timeline follow-back. | From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years. | 
| The amount of patients who find using Guided Imagery beneficial as a form of treatment while undergoing radiotherapy: [Acceptability] | Acceptability of the intervention will be assessed through qualitative interviews with intervention participants. The interviews will assess participant experience in the intervention including thoughts about the intervention content and structure of the intervention. Qualitative data regarding acceptability of the intervention will be gathered through one-on-one, standardized open-ended interviews. | From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact] | Assess the impact of the GI intervention on symptoms of anxiety and depression in patients with head and neck cancer using the Hospital Anxiety and Depression Scales (HADS). | From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years. | 
| The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact] | Assess the impact of the GI intervention on symptoms of anxiety and depression in patients with head and neck cancer using the Memorial Symptom Assessment Scale Short Form (MSAS-SF). | From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years. | 
| The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact] | Assess the impact of the GI intervention on symptoms of anxiety and depression in patients with head and neck cancer using the Functional Assessment of Cancer Therapy-Head and Neck Version (FACT-HN). | From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Guided Imagery, Therapy, Distress, Anxiety, Depression