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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662698
• Other study ID #: 18-1100.cc
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: January 8, 2021

Study information

• Verified date: May 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 8, 2021
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• Guided Imagery
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.

Other:
• Treatment as Usual
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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.