Cognitive Behavioral Therapy for Body Image Distress in Head and Neck Cancer Survivors

(BRIGHT Trial)

Recruiting at 5 trial locations

Overseen By Taylor McLeod, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Psychotropic medications

Disqualifiers: Non-English speakers, Severe psychiatric comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new video-based therapy called BRIGHT, designed to help head and neck cancer survivors with body image issues. Participants will be randomly assigned to either the BRIGHT therapy, which uses cognitive behavioral techniques, or a supportive care group that provides attention and care without focusing on body image. The goal is to determine if BRIGHT can improve participants' body image and overall quality of life. Ideal candidates for this trial have had head or neck cancer, completed treatment within the last year, and are cancer-free but still experience significant body image distress. As an unphased trial, this study offers a unique opportunity to explore innovative therapy methods that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have started or adjusted psychotropic medication in the last 3 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the BRIGHT program, a form of cognitive behavioral therapy (CBT), is safe and well-received by head and neck cancer survivors dealing with body image issues. Studies have found that this video-based therapy is accepted by patients and helps improve their emotional health. These studies have reported no major safety problems. The therapy involves discussing feelings and thoughts with a psychologist and has proven effective for many without causing harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BRIGHT treatment because it offers a new approach to managing body image distress in head and neck cancer survivors. Unlike traditional therapies that might focus on general psychological support, BRIGHT uses a specialized video tele-cognitive behavioral therapy (CBT) delivered one-on-one by a licensed clinical psychologist. This approach is unique because it specifically targets the psychological aspects of body image issues through a structured, theory-based method, potentially providing more tailored and effective support for survivors. Additionally, its delivery via video telehealth offers greater accessibility and convenience, which is crucial for individuals who may have mobility or transportation challenges.

What evidence suggests that BRIGHT could be an effective treatment for body image distress in head and neck cancer survivors?

Research has shown that the BRIGHT program, a form of cognitive behavioral therapy (CBT), can reduce distress about body image in head and neck cancer survivors. In this trial, some participants will receive the BRIGHT intervention, which studies have found significantly improves patients' feelings about their appearance after cancer treatment. Delivered through video sessions with a psychologist, this therapy is easy and convenient to access. Patients have found BRIGHT acceptable, and it shows promise in addressing their body image concerns. Overall, these findings suggest that BRIGHT could effectively alleviate body image distress for head and neck cancer survivors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had curative surgery for head and neck cancer within the last year, are now cancer-free, and experience significant body image distress. They must not be planning major surgeries during the study and should not have severe psychiatric issues or ongoing cognitive behavioral therapy.

Inclusion Criteria

Willingness to be randomized to either BRIGHT or AC

I am over 18 years old.

I don't have any major head or neck surgery planned during the study.

Exclusion Criteria

Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)

I started or changed my mental health medication less than 3 months ago.

I am currently in CBT for another condition and do not want to stop it for this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either BRIGHT or Attention Control interventions delivered via video tele-cognitive behavioral therapy or tele-supportive care

9 months

Regular virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2, 3, 6, and 9 months post-randomization

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• BRIGHT

Trial Overview The BRIGHT clinical trial tests a video tele-cognitive behavioral therapy against an Attention Control supportive care intervention to see which better helps with body image distress in head and neck cancer survivors.

How Is the Trial Designed?

Group I: BRIGHT Experimental Treatment 1 Intervention

BRIGHT is a manualized theory-based video tele-cognitive behavioral therapy (CBT) intervention delivered one-on-one by a licensed clinical psychologist.

Group II: Attention Control Active Control 1 Intervention

The attention control arm is a manualized video tele-supportive care intervention that addresses non-body image aspects of HNC survivorship.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The BRIGHT telemedicine-based intervention was found to be feasible and acceptable for head and neck cancer survivors, with a high session completion rate of 100% and only one dropout among ten participants.

Participants experienced a significant reduction in body image disturbance, with a 34.5% decrease in Body Image Scale scores at one month post-intervention, indicating its potential effectiveness in improving coping behaviors related to body image.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel telemedicine-based intervention to manage body image disturbance in head and neck cancer survivors. Graboyes, EM., Maurer, S., Park, Y., et al.[2022]

The BRIGHT cognitive behavioral therapy program significantly reduces body image distress (BID) in head and neck cancer survivors by decreasing avoidant coping strategies, as shown in a randomized trial with 44 participants.

Changes in coping strategies were linked to improvements in body image distress over time, indicating that addressing coping mechanisms is a key part of the therapy's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress. Graboyes, EM., Kistner-Griffin, E., Hill, EG., et al.[2023]

Body image disturbance (BID) in patients with head and neck cancer tends to improve over time, with studies showing a decrease in severity from pretreatment to posttreatment and as survivors progress further from treatment.

Despite the negative psychosocial and functional impacts of BID, current interventions lack evidence of effectiveness, highlighting a significant gap in treatment strategies and the need for HNC-specific assessment tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Patient-Reported Outcome Measures Assessing Body Image Disturbance in Patients with Head and Neck Cancer. Ellis, MA., Sterba, KR., Brennan, EA., et al.[2020]

The BRIGHT program, a brief tele-cognitive behavioral therapy, was highly acceptable to head and neck cancer survivors, with 95% of participants likely to recommend it to others, indicating strong patient satisfaction.

BRIGHT significantly reduced body image distress (BID) in participants compared to an attention control group, showing a clinically meaningful improvement at 3 months post-intervention, with a large effect size (Cohen d, -0.9).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Brief Tele-Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress: A Pilot Randomized Clinical Trial. Graboyes, EM., Maurer, S., Balliet, W., et al.[2023]

Recent research highlights the significant impact of head and neck cancer on patients' body image due to alterations in physical appearance and bodily function, emphasizing the need for targeted evaluation and treatment.

The review discusses advancements in body image assessment and psychosocial interventions for these patients, indicating a growing recognition of the importance of addressing body image difficulties during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body image: a critical psychosocial issue for patients with head and neck cancer. Fingeret, MC., Teo, I., Goettsch, K.[2018]

The BRIGHT cognitive behavioral therapy (CBT) program significantly reduced depression among head and neck cancer survivors with body image distress, showing a mean difference of -4.3 in depression scores at 3 months compared to an attention control group.

BRIGHT also effectively decreased feelings of shame, stigma, and social isolation in these survivors, indicating its potential to improve overall psychosocial well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial. Graboyes, EM., Kistner-Griffin, E., Hill, EG., et al.[2023]

The BRIGHT program, a tailored cognitive behavioral therapy, significantly reduced depression among 44 head and neck cancer survivors with body image distress compared to an attention control group, showing improvements at both 1 and 3 months post-intervention.

BRIGHT also effectively decreased feelings of shame, stigma, and social isolation in participants, indicating its potential to enhance overall psychosocial well-being for HNC survivors dealing with body image issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a brief cognitive behavioral therapy for head and neck cancer survivors with body image distress: secondary outcomes from the BRIGHT pilot randomized clinical trial. Graboyes, EM., Kistner-Griffin, E., Hill, EG., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37644354/

Efficacy of a brief cognitive behavioral therapy for head and ... BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03831100

Building a Renewed ImaGe After Head & Neck Cancer ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36454561/

Efficacy of a Brief Tele-Cognitive Behavioral Treatment vs ... In this pilot randomized clinical trial, BRIGHT was acceptable, may result in a clinically meaningful improvement in HNC-related BID, and showed a high ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03518671

Building a Renewed ImaGe After Head & Neck Cancer ... This study will evaluate whether a time-limited cognitive behavioral therapy (CBT) intervention in the post-treatment time period can address body image ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425000825

Protocol for a multisite, parallel-group, randomized clinical ... The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that BRIGHT improves BID among HNC survivors relative to an Attention ...

6. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2798918

Efficacy of a Brief Tele–Cognitive Behavioral Treatment vs ... This randomized clinical trial evaluates the acceptability and preliminary efficacy of BRIGHT (Building a Renewed ImaGe after Head and neck ...

7. muschealth.org muschealth.org/health-professionals/progressnotes/2023/winter/therapy-for-body-image-distress

BRIGHT outlook: A brief cognitive behavioral therapy ... A brief cognitive behavioral therapy appears promising for head and neck cancer survivors suffering from body-image distress.

8. cancernetwork.com cancernetwork.com/view/tele-cognitive-therapy-may-improve-body-image-distress-in-head-and-neck-cancer-survivors

Tele-Cognitive Therapy May Improve Body Image Distress ... Findings from a randomized clinical trial suggest that tele-cognitive behavioral therapy may help reduce body image distress among survivors ...