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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treatment as Usual | Active Comparator | The control, or treatment as usual condition, will include an orientation to radiotherapy from the clinic nurse coordinator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elissa Kolva | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36064748 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Treatment as Usual | The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A total of 192 or 373 (51%) of radiation oncology patients were eligible based on pre-screening criteria. 125 were approached and 57 (45.6%) consented for participation. Most participants (n= 44, 77.2%) completed participation in the study. One participant withdrew due to treatment plan changes, the others did not provide reasons, or were lost to follow-up. | Posted | Count of Participants | Participants | From baseline to one month post-radiotherapy. |
|
13 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Studts | University of Colorado Hospital | 303-724-2284 | jamie.studts@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2021 | Dec 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D019018 | Imagery, Psychotherapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants will be randomized to the guided imagery intervention or to treatment as usual.
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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.
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| 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. |
|
| 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. | 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. | From baseline to completion of radiotherapy at 7 weeks. |
| BG001 | Treatment as Usual | The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Treatment as Usual | The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator. 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. |
|
|
| Primary | 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. | 21 participants were scheduled for guided imagery sessions. | Posted | Count of Participants | Participants | From baseline to week one of radiotherapy. |
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|
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| Primary | 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. | Participants in the guided imagery arm reported on weekly use of the guided imagery intervention. | Posted | Count of Participants | Participants | From baseline to one month post-radiotherapy, up to 12 weeks. |
|
|
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| Primary | 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. | Participants in the guided imagery arm who completed the study participated in a qualitative interview about their experience. Data were assessed qualitatively. | Posted | Count of Participants | Participants | From baseline to one month post-radiotherapy. |
|
|
|
| Secondary | 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. | Patients were compared to themselves as well as across groups. We reviewed difference from screening to week 7. Some patients did not complete the assessment at week 7. | Posted | Mean | Standard Deviation | units on a scale | Baseline and completion of radiotherapy at 7 weeks |
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| Secondary | 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. | Patients were compared to themselves as well as across groups. We reviewed difference from screening to 7 weeks. Some patients did not complete the assessment at week 7. | Posted | Mean | Standard Deviation | units on a scale | Baseline and end of radiotherapy at 7 weeks. |
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| Secondary | 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. | Patients were compared to themselves as well as across groups. We reviewed difference from screening to week 7. Some patients did not complete the assessment at week 7. | Posted | Mean | Standard Deviation | units on a scale | From baseline to completion of radiotherapy at 7 weeks. |
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|
| 0 |
| 26 |
| 1 |
| 26 |
| 0 |
| 26 |
| EG001 | Treatment as Usual | The control, or treatment as usual condition, will include an orientation to RT from the clinic nurse coordinator. 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. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D001519 |
| Behavior |
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| Participants who used intervention at week three |
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| Participants who used intervention at week four |
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| Participants who used intervention at week five |
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| Participants who used intervention at week six |
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| Participants who used intervention at week seven |
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| Participants who used intervention at week twelve |
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| No |
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