Clinical trial NCT03662698: Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer
Official title: Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Radiotherapy
Guided Imagery
Therapy
Distress
Anxiety
Depression
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the guided imagery intervention or to treatment as usual.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be aged 18 - 100.
4. Ability to read and communicate in English.
5. A confirmed malignancy of the head and neck region (including metastases from other primary tumors and cancers of unknown primary.
6. Initiation of RT at the University of Colorado Cancer Center.
7. 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).
8. Ability to meet remotely via internet connection or over the phone.

Exclusion Criteria:

1. Any individual who does not meet the inclusion criteria.
2. Those who are determined, by mental health professionals, to be psychiatrically unstable.

Primary outcomes:
measure: The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
timeFrame: From baseline to one month post-radiotherapy.
measure: The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
timeFrame: From baseline to week one of radiotherapy.
measure: The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
timeFrame: From baseline to one month post-radiotherapy, up to 12 weeks.
measure: The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
timeFrame: From baseline to one month post-radiotherapy.
Secondary outcomes:
measure: Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score
timeFrame: Baseline and completion of radiotherapy at 7 weeks
measure: Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score
timeFrame: Baseline and end of radiotherapy at 7 weeks.
measure: The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]
timeFrame: From baseline to completion of radiotherapy at 7 weeks.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Elissa Kolva
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kolva E, Karam SD, Carr AL, Roberts S, Torkko K, Lanning R, Cox-Martin E. Guided imagery for treatment (GIFT): protocol of a pilot trial of guided imagery versus treatment as usual to address radiotherapy-related distress in head and neck cancer. Pilot Feasibility Stud. 2022 Sep 5;8(1):199. doi: 10.1186/s40814-022-01134-9.