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

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ClinicalTrials.gov Identifier: NCT03662698
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE August 31, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date May 6, 2021
Actual Study Start Date  ICMJE October 12, 2018
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer
Official Title  ICMJE Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Guided Imagery
  • Active Comparator: Treatment as Usual
    The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator.
    Intervention: Other: Treatment as Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2020)
57
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
100
Actual Study Completion Date  ICMJE January 8, 2021
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662698
Other Study ID Numbers  ICMJE 18-1100.cc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamie Studts University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP