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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662698
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
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 RT-related symptoms of anxiety and depression in patients with HNC relative to treatment as usual.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Behavioral: Guided Imagery Other: Treatment as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to the guided imagery intervention or to treatment as usual.
Masking: Single (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.
Primary Purpose: Supportive Care
Official Title: Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : August 5, 2024
Estimated Study Completion Date : August 5, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662698


Contacts
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Contact: Elissa Kolva, PhD 720-848-8090 Elissa.Kolva@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Elissa Kolva, PhD    720-848-8090    Elissa.Kolva@ucdenver.edu   
Principal Investigator: Elissa Kolva, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Elissa Kolva, PhD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03662698    
Other Study ID Numbers: 18-1100.cc
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Radiotherapy
Guided Imagery
Therapy
Distress
Anxiety
Depression
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms