Skip to content

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

Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03662698
Enrollment
57
Registered
2018-09-07
Start date
2018-10-12
Completion date
2021-01-08
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Radiotherapy, Guided Imagery, Therapy, Distress, Anxiety, Depression

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.

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.

Interventions

BEHAVIORALGuided 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 University of Colorado Cancer Center.

OTHERTreatment 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 University of Colorado Cancer Center.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be aged 18 - 100. 4. Ability to read and communicate in English. 5. A confirmed malignancy of the head and neck region (including metastases from other primary tumors and cancers of unknown primary. 6. Initiation of RT at the University of Colorado Cancer Center. 7. 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). 8. Ability to meet remotely via internet connection or over the phone.

Exclusion criteria

1. Any individual who does not meet the inclusion criteria. 2. Those who are determined, by mental health professionals, to be psychiatrically unstable.

Design outcomes

Primary

MeasureTime frameDescription
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]From baseline to one month post-radiotherapy.Feasibility of intervention use will be assessed through rates of study completion.
The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]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.

Secondary

MeasureTime frameDescription
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) ScoreBaseline and completion of radiotherapy at 7 weeksAssess 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.
Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) ScoreBaseline and end of radiotherapy at 7 weeks.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.
The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]From baseline to completion of radiotherapy at 7 weeks.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
26
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.
31
Total57

Baseline characteristics

CharacteristicGuided ImageryTreatment as UsualTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants12 Participants18 Participants
Age, Categorical
Between 18 and 65 years
20 Participants19 Participants39 Participants
Age, Continuous58.0 years
STANDARD_DEVIATION 14.3
62.6 years
STANDARD_DEVIATION 9.6
60.5 years
STANDARD_DEVIATION 12.1
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants29 Participants53 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
United States
26 participants31 participants57 participants
Sex: Female, Male
Female
8 Participants5 Participants13 Participants
Sex: Female, Male
Male
18 Participants26 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 31
other
Total, other adverse events
0 / 260 / 31
serious
Total, serious adverse events
1 / 260 / 31

Outcome results

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.

Time frame: 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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Guided ImageryThe Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]Participants completed surveyYes19 Participants
Guided ImageryThe Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]Participants completed surveyNo0 Participants
Guided ImageryThe Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]Intervention was beneficial to participantYes17 Participants
Guided ImageryThe Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]Intervention was beneficial to participantNo2 Participants
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.

Time frame: From baseline to week one of radiotherapy.

Population: 21 participants were scheduled for guided imagery sessions.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who completed two sessions of guided imagery18 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who completed one session of guided imagery3 Participants
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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week twelve0 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at time of CT simulation4 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week one10 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week two9 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week three11 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week four13 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week five9 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week six9 Participants
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]Participants who used intervention at week seven6 Participants
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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Guided ImageryThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]19 Participants
Treatment as UsualThe Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]25 Participants
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.

Time frame: Baseline and 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.

ArmMeasureValue (MEAN)Dispersion
Guided ImageryChange From Baseline in Hospital Anxiety and Depression Scales (HADS) Score1.93 units on a scaleStandard Deviation 8.95
Treatment as UsualChange From Baseline in Hospital Anxiety and Depression Scales (HADS) Score-0.05 units on a scaleStandard Deviation 4.76
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Guided ImageryChange From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score-0.08 units on a scaleStandard Deviation 0.64
Treatment as UsualChange From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score-0.11 units on a scaleStandard Deviation 0.46
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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Guided ImageryThe Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]-16.54 units on a scaleStandard Deviation 21.05
Treatment as UsualThe Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact]-14.9 units on a scaleStandard Deviation 21.2

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026