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

NCT03662698 | Completed Results DMC

• 1 other identifier: 18-1100.cc
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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 radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual.

Conditions

Head and Neck Cancer

Keywords

Radiotherapy; Guided Imagery; Therapy; Distress; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• 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 completion.

  From baseline to one month post-radiotherapy.

• 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.

  From baseline to week one of radiotherapy.

• 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.

  From baseline to one month post-radiotherapy, up to 12 weeks.

• 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.

  From baseline to one month post-radiotherapy.

Secondary Outcomes (3)

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

  Baseline and completion of radiotherapy at 7 weeks

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

  Baseline and end of radiotherapy at 7 weeks.

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

  From baseline to completion of radiotherapy at 7 weeks.

Study Arms (2)

Guided Imagery

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Interventions

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.

Guided Imagery

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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those who are determined, by mental health professionals, to be psychiatrically unstable.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 36064748 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Anxiety Disorders; Depression

Interventions

Imagery, Psychotherapy; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Jamie Studts
• Organization: University of Colorado Hospital

jamie.studts@cuanschutz.edu

303-724-2284

Study Officials

• Elissa Kolva

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the guided imagery intervention or to treatment as usual.

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 7, 2018
• Study Start: October 12, 2018
• Primary Completion: November 9, 2020
• Study Completion: January 8, 2021
• Last Updated: March 13, 2025
• Results First Posted: August 5, 2024

Record last verified: 2025-03

Locations

US (1)