Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Survivorship; Mental Health Issue; Body Image; Body Image Disturbance; Psychosocial Impairment; Head and Neck Cancer

Treatments: Behavioral: Attention Control; Behavioral: BRIGHT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05442957

R37CA269385 (U.S. NIH Grant/Contract)

PRO 00110248

Details and patient eligibility

About

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).

Full description

We will perform a multi-site randomized clinical trial (RCT) comparing BRIGHT with AC to test our hypotheses that BRIGHT reduces BID and improves psychological and social well-being and QOL at 2, 3, 6, and 9-months post-randomization by enhancing body image coping skills and decreasing unhelpful automatic thoughts. HNC survivors with clinically significant BID (N=180) from multiple sites in the United States will be randomized 1:1 to BRIGHT or AC. We will conduct semi-structured interviews with key stakeholders (n=10/site) and in-depth site visits to assess barriers and facilitators of the adoption of BRIGHT and develop an implementation toolkit to enhance the future adoption of BRIGHT into routine clinical care.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years on the day of informed consent

2. History of pathologically confirmed squamous cell carcinoma (or histologic variant) of the 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. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)

5. Cancer-free at the time of accrual

   -patients with known indolent malignancies (e.g., non-melanoma skin cancer, low risk thyroid cancer, untreated prostate cancer, etc) would not exclude a patient from the study

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. IMAGE-HN score > 22

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

BRIGHT

Experimental group

Description:

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

Treatment:

Behavioral: BRIGHT

Attention Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Attention Control