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

May 4, 2021 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
ACTIVE_COMPARATOR: Treatment as Usual
The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, over 2 years.
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]
Time Frame: From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
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]
Time Frame: From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
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]
Time Frame: From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
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]
Time Frame: From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
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]
Time Frame: From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
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]
Time Frame: From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Jamie Studts, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 12, 2018

Primary Completion (ACTUAL)

November 9, 2020

Study Completion (ACTUAL)

January 8, 2021

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (ACTUAL)

September 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1100.cc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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