Clinical trial NCT03831100: Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0
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 2.0)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Eligible participants will complete baseline questionnaires measuring BID and psychological, social, and emotional wellbeing. Participants will then be randomized to BRIGHT (n=24) or AC (n=24) 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. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT.

The control intervention in this study 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.
Primary purpose: SUPPORTIVE_CARE

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 (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.

Eligibility criteria: Inclusion Criteria

1. Age \> 18 years at the time of screening
2. History of pathologically confirmed invasive squamous cell carcinoma (or histologic variant) of the upper aerodigestive tract (oral cavity, pharynx, larynx, nose/paranasal sinuses), carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck
3. History of curative intent surgery with or without adjuvant therapy, with or without reconstruction
4. American Joint Committee on Cancer (AJCC) 8th Edition pathologic stage grouping I-IV
5. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)
6. No planned significant HNC ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the HNC oncologic surgeon at the time of study accrual
7. Willingness to be randomized to either BRIGHT or AC
8. Body Image Scale (BIS) score \>/= 10

Exclusion Criteria:

1. Inability to speak or write English
2. Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial.
3. Initiation or adjustment (\< 3 months of baseline) of psychotropic medication.
4. Severe psychiatric comorbidity (e.g. suicidal ideation, psychosis)

Primary outcomes:
measure: Change in Body Image Scale Score From Baseline to 1-month Post-intervention
timeFrame: 1 month
Secondary outcomes:
measure: Change in Body Image Scale Score From Baseline to 3-months Post-intervention
timeFrame: 3 months
measure: Change in IMAGE-HN Score From Baseline to 1-month Post-intervention
timeFrame: 1 month
measure: Change in IMAGE-HN Score From Baseline to 3-months Post-intervention
timeFrame: 3 months
measure: Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention
timeFrame: 1 month
measure: Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention
timeFrame: 3 months
measure: Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention
timeFrame: 1 month
measure: Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention
timeFrame: 3 months
measure: Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention
timeFrame: 1 month
measure: Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention
timeFrame: 3 months
measure: Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention
timeFrame: 1 month
measure: Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention
timeFrame: 3 months
measure: Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention
timeFrame: 1 month
measure: Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Evan M Graboyes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: