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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery
Treatment as Usual
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Radiotherapy, Guided Imagery, Therapy, Distress, Anxiety, Depression

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided Imagery

Treatment as Usual

Arm Description

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.

The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
August 31, 2018
Last Updated
May 4, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03662698
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 RT-related symptoms of anxiety and depression in patients with HNC 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Radiotherapy, Guided Imagery, Therapy, Distress, Anxiety, Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to the guided imagery intervention or to treatment as usual.
Masking
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.
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Imagery
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator.
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility]
Description
Feasibility of intervention use will be assessed through rates of study enrollment.
Time Frame
From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
Title
The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility]
Description
Feasibility of intervention use will be assessed through rates of GI session attendance.
Time Frame
From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
Title
The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility]
Description
Feasibility of intervention use will be assessed through self-reported use of the GI intervention measured through timeline follow-back.
Time Frame
From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
Title
The amount of patients who find using Guided Imagery beneficial as a form of treatment while undergoing radiotherapy: [Acceptability]
Description
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.
Time Frame
From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
Secondary Outcome Measure Information:
Title
The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact]
Description
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).
Time Frame
From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
Title
The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact]
Description
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).
Time Frame
From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.
Title
The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact]
Description
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).
Time Frame
From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Studts
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36064748
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.
Results Reference
derived

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

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