Trial Outcomes & Findings for Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer (NCT NCT03662698)
NCT ID: NCT03662698
Last Updated: 2025-03-13
Results Overview
Feasibility of intervention use will be assessed through rates of study completion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
From baseline to one month post-radiotherapy.
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
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Overall Study
STARTED
|
26
|
31
|
|
Overall Study
COMPLETED
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Guided Imagery
n=26 Participants
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.
|
Treatment as Usual
n=31 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
31 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to one month post-radiotherapy.Population: 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.
Feasibility of intervention use will be assessed through rates of study completion.
Outcome measures
| Measure |
Guided Imagery
n=26 Participants
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.
|
Treatment as Usual
n=31 Participants
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.
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|---|---|---|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
|
19 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: From baseline to week one of radiotherapy.Population: 21 participants were scheduled for guided imagery sessions.
Feasibility of intervention use will be assessed through rates of GI session attendance.
Outcome measures
| Measure |
Guided Imagery
n=21 Participants
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.
|
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.
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|---|---|---|
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The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who completed two sessions of guided imagery
|
18 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who completed one session of guided imagery
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3 Participants
|
—
|
PRIMARY outcome
Timeframe: From baseline to one month post-radiotherapy, up to 12 weeks.Population: Participants in the guided imagery arm reported on weekly use of the guided imagery intervention.
Feasibility of intervention use will be assessed through self-reported use of the GI intervention measured through timeline follow-back.
Outcome measures
| Measure |
Guided Imagery
n=26 Participants
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.
|
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.
|
|---|---|---|
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The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at time of CT simulation
|
4 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week one
|
10 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week two
|
9 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week three
|
11 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week four
|
13 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week five
|
9 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week six
|
9 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week seven
|
6 Participants
|
—
|
|
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
Participants who used intervention at week twelve
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From baseline to one month post-radiotherapy.Population: Participants in the guided imagery arm who completed the study participated in a qualitative interview about their experience. Data were assessed qualitatively.
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.
Outcome measures
| Measure |
Guided Imagery
n=19 Participants
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.
|
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.
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|---|---|---|
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The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
Participants completed survey · Yes
|
19 Participants
|
—
|
|
The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
Participants completed survey · No
|
0 Participants
|
—
|
|
The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
Intervention was beneficial to participant · Yes
|
17 Participants
|
—
|
|
The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
Intervention was beneficial to participant · No
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and completion of radiotherapy at 7 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Guided Imagery
n=14 Participants
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.
|
Treatment as Usual
n=21 Participants
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.
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|---|---|---|
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Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score
|
1.93 units on a scale
Standard Deviation 8.95
|
-0.05 units on a scale
Standard Deviation 4.76
|
SECONDARY outcome
Timeframe: Baseline and end of radiotherapy at 7 weeks.Population: 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.
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.
Outcome measures
| Measure |
Guided Imagery
n=13 Participants
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.
|
Treatment as Usual
n=19 Participants
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.
|
|---|---|---|
|
Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score
|
-0.08 units on a scale
Standard Deviation 0.64
|
-0.11 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: From baseline to completion of radiotherapy at 7 weeks.Population: 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.
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.
Outcome measures
| Measure |
Guided Imagery
n=13 Participants
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.
|
Treatment as Usual
n=21 Participants
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.
|
|---|---|---|
|
The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]
|
-16.54 units on a scale
Standard Deviation 21.05
|
-14.9 units on a scale
Standard Deviation 21.2
|
Adverse Events
Guided Imagery
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Guided Imagery
n=26 participants at risk
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.
|
Treatment as Usual
n=31 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
3.8%
1/26 • Number of events 1 • 13 weeks
|
0.00%
0/31 • 13 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place