Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03831100
Status:
COMPLETED
Last Update Posted:
2023-08-09
First Post:
2019-02-04
Brief Title:
Building a Renewed ImaGe After Head Neck Cancer Treatment BRIGHT 20
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Single-Site Parallel-Group Randomized-Controlled Pilot Trial Comparing BRIGHT With Active Control in Reducing Body Image Disturbance Among Head and Neck Cancer Survivors BRIGHT 20
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIGHT
Brief Summary:
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
Detailed Description:
Following screening and informed consent eligible participants will complete baseline questionnaires measuring BID and psychological social and emotional wellbeing Participants n44 will then be randomized 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21CA245941-01A1 | NIH | None | httpsreporternihgovquickSearch1R21CA245941-01A1 |