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NCT Number: NCT03662698

Effect of Guided Imagery for Radiotherapy-Related Distress in 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 radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual.

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Key information

Conditions

Head and Neck Cancer Anxiety Disorders Behavior Behavioral Symptoms Depression Head and Neck Neoplasms Mental Disorders Neoplasms Neoplasms by Site

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GUIDED IMAGERY

Behavioral

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 University of Colorado Cancer Center.

Treatment as Usual

Other

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 University of Colorado Cancer Center.

Primary outcomes

  1. The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]

    Time frame: From baseline to one month post-radiotherapy.

    Feasibility of intervention use will be assessed through rates of study completion.

  2. The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]

    Time frame: From baseline to week one of radiotherapy.

    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.

    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.

    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 outcomes

  1. Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score

    Time frame: Baseline and completion of radiotherapy at 7 weeks

    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 Scale (HADS).

    HADS is a 14-item self-report measure of anxiety and depression symptoms for use in a medically-ill patients. The measure contains 7 anxiety items and 7 depression items, corresponding to the two subscales. Each item is assessed with a 4 point Likert scale (range: 0-3) and the participant is asked to identify how much a given statement is applicable (Most of the time, A lot of the time, From time to time, Occasionally or Not at all). Subscale scores range from 0 to 21 with higher scores indicating greater severity of symptoms. A score of 8 on either subscale identifies cases of anxiety or depressive disorders.

    The total score is reported here, which is summed from the subscale scores. Min = 0, Max = 42.

  2. Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score

    Time frame: Baseline and end of radiotherapy at 7 weeks.

    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 MSAS-SF assesses the occurrence of 26 physical symptoms and four psychological symptoms from 0 ("no symptom"), rarely (1), occasionally (2), frequently (3), and almost constantly (4). The distress that each symptom causes to the respondent is rated on a 5-point scale (again with range 0-4) including "not at all", "a little bit", "somewhat", "quite a bit", and "very much". Responses regarding symptom distress are used to create the Total Symptom Distress score (TMSAS), which is the average of the symptom scores across all symptoms in the form. The minimum value is 0 and the maximum value is 4. Higher scores indicate that the patient experienced a greater level of distress, which is a worse outcome. What is reported is the difference in score from baseline.

  3. The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]

    Time frame: From baseline to completion of radiotherapy at 7 weeks.

    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). The FACT-HN is a 27-item self-report instrument designed to assess quality of life for patients with head and neck cancer. Items assess four domains: physical, social/family, emotional, and functional well-being (scores ranging 0 to 28) as well as specific items assessing head and neck symptoms. The scale uses a Likert-type scale (0 to 4) to produce subscale and total scores (ranging from 0-108) with higher scores indicating higher quality of life. It is a reliable, valid measure of quality of life for patients with head and neck cancer.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 7, 2018
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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