An interventional study of Guided Imagery and Treatment as Usual in Head and Neck Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 57 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
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
The control, or treatment as usual condition, will include an orientation to radiotherapy from the clinic nurse coordinator.
Other: Treatment as Usual
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to one month post-radiotherapy.
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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to completion of radiotherapy at 7 weeks.
| Milestone | Guided Imagery | Treatment as Usual |
|---|---|---|
| Started | 26 | 31 |
| Completed | 19 | 25 |
| Not completed | 7 | 6 |
Feasibility of intervention use will be assessed through rates of study completion.
| Participants | Guided Imagery | Treatment as Usual |
|---|---|---|
| The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility] | 19 | 25 |
Feasibility of intervention use will be assessed through rates of GI session attendance.
| Participants | Guided Imagery |
|---|---|
| Participants who completed two sessions of guided imagery | 18 |
| Participants who completed one session of guided imagery | 3 |
Feasibility of intervention use will be assessed through self-reported use of the GI intervention measured through timeline follow-back.
| Participants | Guided Imagery |
|---|---|
| Participants who used intervention at time of CT simulation | 4 |
| Participants who used intervention at week one | 10 |
| Participants who used intervention at week two | 9 |
| Participants who used intervention at week three | 11 |
| Participants who used intervention at week four | 13 |
| Participants who used intervention at week five | 9 |
| Participants who used intervention at week six | 9 |
| Participants who used intervention at week seven | 6 |
| Participants who used intervention at week twelve | 0 |
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.
| Participants | Guided Imagery |
|---|---|
| Participants completed survey — Yes | 19 |
| Participants completed survey — No | 0 |
| Intervention was beneficial to participant — Yes | 17 |
| Intervention was beneficial to participant — No | 2 |
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.
| units on a scale | Guided Imagery | Treatment as Usual |
|---|---|---|
| Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score | 1.93 ± 8.95 | -0.05 ± 4.76 |
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.
| units on a scale | Guided Imagery | Treatment as Usual |
|---|---|---|
| Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score | -0.08 ± 0.64 | -0.11 ± 0.46 |
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.
| units on a scale | Guided Imagery | Treatment as Usual |
|---|---|---|
| The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact] | -16.54 ± 21.05 | -14.9 ± 21.2 |
Collected over 13 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Guided Imagery | 0/26 (0%) | 1/26 (3.8%) | 0/26 (0%) |
| Treatment as Usual | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Event | Guided Imagery | Treatment as Usual |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 1/26 | 0/31 |
| Age, Categorical(Participants) | Guided Imagery | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 19 | 39 |
| >=65 years | 6 | 12 | 18 |
| Age, Continuous(years) | Guided Imagery | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 58.0 ± 14.3 | 62.6 ± 9.6 | 60.5 ± 12.1 |
| Sex: Female, Male(Participants) | Guided Imagery | Treatment as Usual | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 18 | 26 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Guided Imagery | Treatment as Usual | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 24 | 29 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Guided Imagery | Treatment as Usual | Total |
|---|---|---|---|
| United States | 26 | 31 | 57 |
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University of Colorado, Denver