Trial Outcomes & Findings for Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0 (NCT NCT03831100)
NCT ID: NCT03831100
Last Updated: 2023-08-09
Results Overview
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.
COMPLETED
NA
54 participants
1 month
2023-08-09
Participant Flow
Participant milestones
| Measure |
BRIGHT
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
Active Control (AC) is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
BRIGHT
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
Active Control (AC) is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Overall Study
Patients who developed a recurrent or new primary cancer went off study per protocol
|
6
|
4
|
Baseline Characteristics
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0
Baseline characteristics by cohort
| Measure |
BRIGHT
n=26 Participants
The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist.
|
Active Control
n=28 Participants
AC consists of 5 weekly sessions of videos about head and neck cancer (HNC) survivorship that are delivered using a telemedicine platform.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
62.5 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in Body Image Scale Score From Baseline to 1-month Post-intervention
|
-3.5 score on a scale
Interval -5.4 to -1.5
|
-0.7 score on a scale
Interval -2.8 to 1.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in Body Image Scale Score From Baseline to 3-months Post-intervention
|
-7.3 score on a scale
Interval -9.7 to -4.8
|
-1.6 score on a scale
Interval -3.9 to 0.7
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in IMAGE-HN Score From Baseline to 1-month Post-intervention
|
-8.1 score on a scale
Interval -13.4 to -2.8
|
0.5 score on a scale
Interval -5.3 to 6.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in IMAGE-HN Score From Baseline to 3-months Post-intervention
|
-17.8 score on a scale
Interval -24.5 to -11.1
|
-1.6 score on a scale
Interval -7.8 to 4.6
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention
|
-4.8 score on a scale
Interval -8.9 to 0.6
|
-1.8 score on a scale
Interval -5.6 to 1.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention
|
-10.6 score on a scale
Interval -15.3 to -5.8
|
-1.8 score on a scale
Interval -6.1 to 2.6
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention
|
-2.7 score on a scale
Interval -5.1 to 0.2
|
0.5 score on a scale
Interval -1.7 to 2.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention
|
-3.1 score on a scale
Interval -6.1 to -0.1
|
0.9 score on a scale
Interval -1.8 to 3.6
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention
|
-1.6 score on a scale
Interval -4.3 to 1.1
|
-0.3 score on a scale
Interval -2.8 to 2.2
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention
|
-3.1 score on a scale
Interval -5.6 to -0.5
|
-0.2 score on a scale
Interval -2.5 to 2.1
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention
|
3.0 score on a scale
Interval 0.6 to 5.5
|
-1.0 score on a scale
Interval -3.3 to 1.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention
|
6.2 score on a scale
Interval 3.4 to 9.0
|
2.2 score on a scale
Interval -0.4 to 4.8
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention
|
-2.9 score on a scale
Interval -5.3 to -0.4
|
-1.3 score on a scale
Interval -3.4 to 0.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The efficacy analytic 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.
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.
Outcome measures
| Measure |
BRIGHT
n=20 Participants
BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.
|
Active Control
n=24 Participants
AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.
|
|---|---|---|
|
Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention
|
-3.3 score on a scale
Interval -5.7 to -0.9
|
-1.0 score on a scale
Interval -3.3 to 1.2
|
Adverse Events
BRIGHT
Active Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place