An interventional study of BRIGHT and Active Control in Head and Neck Cancer, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Supportive care
Head and neck cancer (HNC) survivors with body image-related distress (BID) will be randomized to 5-weeks of tablet-based BRIGHT or tablet-based active control (AC; electronic information about HNC recovery). Participants will complete validated measures of BID and psychological, social, and emotional wellbeing to assess the preliminary clinical impact of BRIGHT on BID in HNC survivors. Participants will also complete validated measures of body image coping behavior to assess the role of image coping behavior as the behavioral mechanism of BRIGHT.
Following screening and informed consent, eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants (n=44) will then be randomized 1:1 to BRIGHT or AC and undergo weekly, tablet-based BRIGHT or AC for 5 weeks.
The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. The control intervention will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. Participants in the AC arm will thus undergo 5 weekly, 60-minute, tablet-based video sessions in which they undergo non-manualized discussions with a non-trained member of the study team.
Following randomization, patients in each arm will receive a study-issued, cellular-enabled iPad loaded with Vidyo, a video teleconference platform that allows the participant to connect to the study psychologist (BRIGHT) or AC. Vidyo allows face-face communication for tele-cognitive behavioral therapy (CBT) for HNC patients who can articulate well, but also includes a within-video text message feature for aphonic (due to surgical removal of the larynx) or severely dysarthric (due to surgical removal of a significant amount of the tongue) HNC patients who are unable to participate in tele-CBT by speaking. The study iPads are locked to prevent downloading of additional applications. Participants receive a pictorial instructional booklet for logging on to Vidyo. No user names, logins, or web addresses are necessary to connect to the BRIGHT session. The participant simply clicks on the Vidyo application which takes the participant to the assigned teleconference room. At the conclusion of the 5-week intervention, participants return iPads to the study team in pre-addressed, stamped, padded mailers that are provided to the patient.
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This study's enrollment of 54 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
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Exclusion Criteria:
The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT.
Behavioral: BRIGHT
The control intervention in this study will be matched to replicate the frequency, intensity, and delivery method of BRIGHT. AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship.
Behavioral: Active Control
The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT.
AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session (Table 5) is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship.
Change in Body Image Scale Score From Baseline to 1-month Post-intervention
The Body Image Scale (BIS) is a validated, 10-item patient-reported outcome measure (PROM) that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.
Time frame: 1 month
Change in Body Image Scale Score From Baseline to 3-months Post-intervention
The BIS is a validated, 10-item patient-reported outcome measure that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.
Time frame: 3 months
Change in IMAGE-HN Score From Baseline to 1-month Post-intervention
The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related body image distress (BID) due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.
Time frame: 1 month
Change in IMAGE-HN Score From Baseline to 3-months Post-intervention
The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related BID due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.
Time frame: 3 months
Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention
The Shame and Stigma Scale is a 20-item, validated, unidimensional PROM that measures four domains (shame with appearance, stigma, regret, and social/speech concerns) in patients with HNC over the prior 7 days. Responses include 'never', 'seldom', 'sometimes', 'often', and 'all the time' and are scored 0-4, respectively. The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored) and thus ranges from 0-80. Higher scores reflect greater shame and stigma from HNC.
Time frame: 1 month
Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention
The Shame and Stigma Scale is a 20-item, validated, unidimensional PROM that measures four domains (shame with appearance, stigma, regret, and social/speech concerns) in patients with HNC over the prior 7 days. Responses include 'never', 'seldom', 'sometimes', 'often', and 'all the time' and are scored 0-4, respectively. The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored) and thus ranges from 0-80. Higher scores reflect greater shame and stigma from HNC.
Time frame: 3 months
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention
PROMIS SF v1.0-Depression 8a is a validated, 8-item measure developed by the NIH to assess self-reported negative mood, views of self, and decreased positive affect and engagement. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). Higher scores reflect more severe depressive symptoms.
Time frame: 1 month
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention
PROMIS SF v1.0-Depression 8a is a validated, 8-item measure developed by the NIH to assess self-reported negative mood, views of self, and decreased positive affect and engagement. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). Higher scores reflect more severe depressive symptoms.
Time frame: 3 months
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention
The PROMIS SF v1.0-Anxiety 8a is a validated, 8-item measure developed by the NIH to assess self-reported fear, worry, and hyperarousal46. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe anxiety.
Time frame: 1 month
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention
The PROMIS SF v1.0-Anxiety 8a is a validated, 8-item measure developed by the NIH to assess self-reported fear, worry, and hyperarousal46. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe anxiety.
Time frame: 3 months
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention
PROMIS SF v2.0-Satisfaction with Social Roles and Activities 8a is a validated, 8-item, measure developed by the NIH to assess self-reported satisfaction with performing one's usual social roles and activities. Items are scored using a 5-point Likert scale from 'not at all' to 'very much' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect greater satisfaction with social roles and activities.
Time frame: 1 month
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention
PROMIS SF v2.0-Satisfaction with Social Roles and Activities 8a is a validated, 8-item, measure developed by the NIH to assess self-reported satisfaction with performing one's usual social roles and activities. Items are scored using a 5-point Likert scale from 'not at all' to 'very much' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect greater satisfaction with social roles and activities.
Time frame: 3 months
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention
PROMIS SF v2.0-Social Isolation 8a is a validated, 8-item, measure developed by the NIH to assess self-reported perceptions of being avoided, excluded or unknown by others. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe social isolation.
Time frame: 1 month
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention
PROMIS SF v2.0-Social Isolation 8a is a validated, 8-item, measure developed by the NIH to assess self-reported perceptions of being avoided, excluded or unknown by others. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe social isolation.
Time frame: 3 months
| Milestone | BRIGHT | Active Control |
|---|---|---|
| Started | 26 | 28 |
| Completed | 20 | 24 |
| Not completed | 6 | 4 |
| Withdrew: Patients who developed a recurrent or new primary cancer went off study per protocol | 6 | 4 |
The Body Image Scale (BIS) is a validated, 10-item patient-reported outcome measure (PROM) that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in Body Image Scale Score From Baseline to 1-month Post-intervention | -3.5 (-5.4 to -1.5) | -0.7 (-2.8 to 1.5) |
The BIS is a validated, 10-item patient-reported outcome measure that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in Body Image Scale Score From Baseline to 3-months Post-intervention | -7.3 (-9.7 to -4.8) | -1.6 (-3.9 to 0.7) |
The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related body image distress (BID) due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in IMAGE-HN Score From Baseline to 1-month Post-intervention | -8.1 (-13.4 to -2.8) | 0.5 (-5.3 to 6.4) |
The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related BID due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in IMAGE-HN Score From Baseline to 3-months Post-intervention | -17.8 (-24.5 to -11.1) | -1.6 (-7.8 to 4.6) |
The Shame and Stigma Scale is a 20-item, validated, unidimensional PROM that measures four domains (shame with appearance, stigma, regret, and social/speech concerns) in patients with HNC over the prior 7 days. Responses include 'never', 'seldom', 'sometimes', 'often', and 'all the time' and are scored 0-4, respectively. The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored) and thus ranges from 0-80. Higher scores reflect greater shame and stigma from HNC.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention | -4.8 (-8.9 to 0.6) | -1.8 (-5.6 to 1.9) |
The Shame and Stigma Scale is a 20-item, validated, unidimensional PROM that measures four domains (shame with appearance, stigma, regret, and social/speech concerns) in patients with HNC over the prior 7 days. Responses include 'never', 'seldom', 'sometimes', 'often', and 'all the time' and are scored 0-4, respectively. The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored) and thus ranges from 0-80. Higher scores reflect greater shame and stigma from HNC.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention | -10.6 (-15.3 to -5.8) | -1.8 (-6.1 to 2.6) |
PROMIS SF v1.0-Depression 8a is a validated, 8-item measure developed by the NIH to assess self-reported negative mood, views of self, and decreased positive affect and engagement. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). Higher scores reflect more severe depressive symptoms.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention | -2.7 (-5.1 to 0.2) | 0.5 (-1.7 to 2.8) |
PROMIS SF v1.0-Depression 8a is a validated, 8-item measure developed by the NIH to assess self-reported negative mood, views of self, and decreased positive affect and engagement. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). Higher scores reflect more severe depressive symptoms.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention | -3.1 (-6.1 to -0.1) | 0.9 (-1.8 to 3.6) |
The PROMIS SF v1.0-Anxiety 8a is a validated, 8-item measure developed by the NIH to assess self-reported fear, worry, and hyperarousal46. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe anxiety.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention | -1.6 (-4.3 to 1.1) | -0.3 (-2.8 to 2.2) |
The PROMIS SF v1.0-Anxiety 8a is a validated, 8-item measure developed by the NIH to assess self-reported fear, worry, and hyperarousal46. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe anxiety.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention | -3.1 (-5.6 to -0.5) | -0.2 (-2.5 to 2.1) |
PROMIS SF v2.0-Satisfaction with Social Roles and Activities 8a is a validated, 8-item, measure developed by the NIH to assess self-reported satisfaction with performing one's usual social roles and activities. Items are scored using a 5-point Likert scale from 'not at all' to 'very much' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect greater satisfaction with social roles and activities.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention | 3.0 (0.6 to 5.5) | -1.0 (-3.3 to 1.3) |
PROMIS SF v2.0-Satisfaction with Social Roles and Activities 8a is a validated, 8-item, measure developed by the NIH to assess self-reported satisfaction with performing one's usual social roles and activities. Items are scored using a 5-point Likert scale from 'not at all' to 'very much' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect greater satisfaction with social roles and activities.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention | 6.2 (3.4 to 9.0) | 2.2 (-0.4 to 4.8) |
PROMIS SF v2.0-Social Isolation 8a is a validated, 8-item, measure developed by the NIH to assess self-reported perceptions of being avoided, excluded or unknown by others. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe social isolation.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention | -2.9 (-5.3 to -0.4) | -1.3 (-3.4 to 0.9) |
PROMIS SF v2.0-Social Isolation 8a is a validated, 8-item, measure developed by the NIH to assess self-reported perceptions of being avoided, excluded or unknown by others. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe social isolation.
| score on a scale | BRIGHT | Active Control |
|---|---|---|
| Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention | -3.3 (-5.7 to -0.9) | -1.0 (-3.3 to 1.2) |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BRIGHT | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Active Control | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
The efficacy analysis population consisted of all eligible, randomized, evaluable patients. Patients who developed a recurrent or new primary cancer went off study per protocol and were not evaluable.
| Age, Continuous(years) | BRIGHT | Active Control | Total |
|---|---|---|---|
| Median | 63 (31 to 83) | 62.5 (41 to 76) | 63 (31 to 83) |
| Sex: Female, Male(Participants) | BRIGHT | Active Control | Total |
|---|---|---|---|
| Female | 13 | 16 | 29 |
| Male | 13 | 12 | 25 |
| Ethnicity (NIH/OMB)(Participants) | BRIGHT | Active Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 26 | 28 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BRIGHT | Active Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 6 | 9 |
| White | 23 | 22 | 45 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | BRIGHT | Active Control | Total |
|---|---|---|---|
| United States | 26 | 28 | 54 |
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Medical University of South Carolina