Head and Neck CancerNCT03662698
Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer
A study testing Guided Imagery and Treatment as Usual in people with Head and Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Guided Imagery and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2018to 8 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any individual who does not meet the inclusion criteria.
- Those who are determined, by mental health professionals, to be psychiatrically unstable.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for 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.
Read the 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 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Guided Imagery, Treatment as Usual
- Keywords
- Radiotherapy, Guided Imagery, Therapy, Distress, Anxiety, Depression
- Medical subject headings
- Head and Neck Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
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 UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to one month post-radiotherapy.
Secondary outcomes (3)
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score
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.
Measured: Baseline and completion of radiotherapy at 7 weeks
Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score
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.
Measured: Baseline and end of radiotherapy at 7 weeks.
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). 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.
Measured: From baseline to completion of radiotherapy at 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start12 Oct 2018
- Primary completion9 Nov 2020
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to the guided imagery intervention or to treatment as usual.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elissa Kolva, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662698
- Sponsor's protocol ID
- 18-1100.cc
- Status last verified
- Mar 2025
- First submitted
- 31 Aug 2018
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36064748
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03662698
- Acronym / sponsor ID
- 18-1100.cc
- Conditions
- Head and Neck Cancer
- Keywords
- Radiotherapy, Guided Imagery, Therapy, Distress, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to the guided imagery intervention or to treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Behavioral: Guided ImageryThe 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. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualThe control, or treatment as usual condition, will include an orientation to radiotherapy from the clinic nurse coordinator. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Any individual who does not meet the inclusion criteria.
- Those who are determined, by mental health professionals, to be psychiatrically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryGI 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. | Behavioural | Guided Imagery |
| Treatment as UsualThis 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. | Other | Treatment as Usual |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score
Time frame: Baseline and completion of radiotherapy at 7 weeks
Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score
Time frame: Baseline and end of radiotherapy at 7 weeks.
The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]
Time frame: From baseline to completion of radiotherapy at 7 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36064748Kolva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elissa Kolva principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery and Treatment as Usual in people with Head and Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility] (time frame: From baseline to one month post-radiotherapy.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.