Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Study Overview
Brief 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.
Detailed Description
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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to study design, it is not possible to blind either participants or investigators to study condition. However, the biostatistician will be blinded to participant group to minimize bias in analyzing the data.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 -
- •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.
Arms & Interventions
Guided Imagery
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.
Intervention: Guided Imagery (Behavioral)
Treatment as Usual
The control, or treatment as usual condition, will include an orientation to radiotherapy from the clinic nurse coordinator.
Intervention: Treatment as Usual (Other)
Outcomes
Primary Outcomes
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Time Frame: From baseline to one month post-radiotherapy, up to 12 weeks.
Feasibility of intervention use will be assessed through self-reported use of the GI intervention measured through timeline follow-back.
The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
Time Frame: From baseline to one month post-radiotherapy.
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.
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Time Frame: From baseline to one month post-radiotherapy.
Feasibility of intervention use will be assessed through rates of study completion.
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Time Frame: From baseline to week one of radiotherapy.
Feasibility of intervention use will be assessed through rates of GI session attendance.
Secondary Outcomes
- Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score(Baseline and completion of radiotherapy at 7 weeks)
- Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score(Baseline and end of radiotherapy at 7 weeks.)
- The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact](From baseline to completion of radiotherapy at 7 weeks.)