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

(BRIGHT Trial)

Recruiting at 3 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

Trial Summary

What is the purpose of this trial?

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure \[PROM\] of HNC-related body image distress \[BID\]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators).

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.

What data supports the effectiveness of the treatment for body image distress in head and neck cancer survivors?

Research shows that the BRIGHT program, a type of cognitive behavioral therapy, helps reduce body image distress in head and neck cancer survivors, which can improve their quality of life by addressing issues like depression and social isolation. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy safe for head and neck cancer survivors with body image distress?

The studies on BRIGHT, a form of Cognitive Behavioral Therapy for head and neck cancer survivors, do not report any safety concerns, suggesting it is generally safe for use in humans. ^{1 2 3 6 7}

How is the BRIGHT treatment different from other treatments for body image distress in head and neck cancer survivors?

BRIGHT is unique because it is a brief, tailored cognitive behavioral therapy (CBT) specifically designed to help head and neck cancer survivors with body image distress, using a telemedicine-based approach to make it more accessible. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a novel telemedicine-based intervention to manage body image disturbance in head and neck cancer survivors. [2022]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Body image: a critical psychosocial issue for patients with head and neck cancer. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A Systematic Review of Patient-Reported Outcome Measures Assessing Body Image Disturbance in Patients with Head and Neck Cancer. [2020]

6. United States 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. [2023]

7. United States 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. [2023]