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

Not Applicable

Completed

Conditions: Head and Neck Cancer

Interventions: Other: Treatment as Usual
Behavioral: Guided Imagery

Registration Number: NCT03662698

Lead Sponsor: University of Colorado, Denver

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 57

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	Treatment as Usual	The control, or treatment as usual condition, will include an orientation to radiotherapy from the clinic nurse coordinator.
Guided Imagery	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.

Primary Outcome Measures

Name	Time	Method
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]	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]	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score	Baseline and completion of radiotherapy at 7 weeks	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 Scale (HADS). HADS is a 14-item self-report measure of anxiety and depression symptoms for use in a medically-ill patients. The measure contains 7 anxiety items and 7 depression items, corresponding to the two subscales. Each item is assessed with a 4 point Likert scale (range: 0-3) and the participant is asked to identify how much a given statement is applicable (Most of the time, A lot of the time, From time to time, Occasionally or Not at all). Subscale scores range from 0 to 21 with higher scores indicating greater severity of symptoms. A score of 8 on either subscale identifies cases of anxiety or depressive disorders. The total score is reported here, which is summed from the subscale scores. Min = 0, Max = 42.
Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score	Baseline and end of radiotherapy at 7 weeks.	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). The MSAS-SF assesses the occurrence of 26 physical symptoms and four psychological symptoms from 0 ("no symptom"), rarely (1), occasionally (2), frequently (3), and almost constantly (4). The distress that each symptom causes to the respondent is rated on a 5-point scale (again with range 0-4) including "not at all", "a little bit", "somewhat", "quite a bit", and "very much". Responses regarding symptom distress are used to create the Total Symptom Distress score (TMSAS), which is the average of the symptom scores across all symptoms in the form. The minimum value is 0 and the maximum value is 4. Higher scores indicate that the patient experienced a greater level of distress, which is a worse outcome. What is reported is the difference in score from baseline.
The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]	From baseline to completion of radiotherapy at 7 weeks.	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). The FACT-HN is a 27-item self-report instrument designed to assess quality of life for patients with head and neck cancer. Items assess four domains: physical, social/family, emotional, and functional well-being (scores ranging 0 to 28) as well as specific items assessing head and neck symptoms. The scale uses a Likert-type scale (0 to 4) to produce subscale and total scores (ranging from 0-108) with higher scores indicating higher quality of life. It is a reliable, valid measure of quality of life for patients with head and neck cancer.