Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Radiotherapy tattoos will be applied using an invisible UV fluorescent ink that can only be detected while illuminated with a special ultraviolet flashlight.

Radiotherapy tattoos will be applied using standard black ink.

The use of UV tattoo ink results in a tattoo that is visible only under an ultraviolet light. Conventional black tattoo ink is replaced with UV ink for the application of radiotherapy "dot" tattoos. Handheld UV flashlights are used to make the tattoos visible for use during radiotherapy treatment set-up.

UV fluorescent ink

Julian Kim, MD, MSc

Erin V Toews, B.Sc., RTT

A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. The effect of tattoo type on quality of life will be measured objectively using the externally validated body-image satisfaction (BIS) scale as the primary outcome of interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period of 18 months.

Breast cancer patients ages 18-60 who are planned for adjuvant radiotherapy and who meet all inclusion/exclusion criteria will be offered voluntary participation in this trial. Recruitment will be open for approximately 18 months; it is anticipated that 1-2 patients will be recruited per week until the planned sample size is met. Participants will be stratified into three groups depending on their self-reported baseline Body-image satisfaction (BIS) score and will then be randomly allocated to receive conventional dark ink or UV fluorescent tattoos using permutated block randomization (4 patients per block) to ensure balance of BIS baseline average between study arms.

The investigators focus is to improve the current tattooing technique for breast cancer patients by introducing an alternate method that takes the patient's psychological perceptions of tattooing into account while first and foremost, continuing to guarantee that the current standard of accuracy in treatment delivery is maintained or improved. The investigators goal of decreasing the psychological effect of permanent radiotherapy tattoos aligns with CancerCare Manitoba's mission to improve the outcomes and quality of life for Manitobans with cancer.

Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos

Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos for Localization of Adjuvant Radiotherapy Fields in Breast Cancer Patients

Mean BIS scores at each time point will be calculated along with standard deviation and will be compared using the student t-test.

Set-up accuracy will be assessed using orthogonal image sets from fractions 1, 2, 3 \& one day treatment week 2 for each participant. Pre-imaging couch angle, vertical, longitudinal and lateral positions will be compared to the post-imaging values and evaluated based on our departmental couch adjustment tolerances for image-guided radiation therapy.

The average time(Min) it takes to complete the tattooing procedure during simulation will be collected and compared between the two arms.

The average time(Min) it takes to complete daily treatment set-up will be collected and compared between the two arms.

Clinical practicability will be evaluated qualitatively through feedback from radiation therapists through a survey measuring their satisfaction with the UV tattooing method.

CancerCare Manitoba

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Self-limited cognitive behavioral therapy (CBT) delivered via 6 weekly sessions, face-face

Up to one year after completion of treatment, patients with body image disturbance (BID) as determined by a Body Image Scale (BIS) score \> 5 will undergo time-limited CBT consisting of 6 weekly sessions. Each session will be guided by the HNC BID module that we develop but customized to each patient's specific concerns. Each session will last \~60 minutes and be conducted one-one with a psychologist. Patients will complete questionnaires prior to CBT and 1 and 3 months after CBT.

Self-limited cognitive behavioral therapy (CBT) delivered via 6 weekly sessions, via tablet-based telemedicine platform

Up to one year after completion of treatment, patients with body image disturbance (BID) as determined by a Body Image Scale (BIS) score \> 5 will undergo time-limited CBT consisting of 6 weekly sessions. Each session will be guided by the HNC BID module that we develop but customized to each patient's specific concerns. Each session will last \~60 minutes and be conducted one-one with a psychologist. Patients will complete questionnaires prior to CBT and 1 and 3 months after CBT. To overcome the expected travel distance-related barrier to receipt of CBT, patients will receive the intervention via tablet-based telemedicine delivery platform

self-limited cognitive behavioral therapy delivered weekly for 6 weeks via face-face delivery method

cognitive behavioral therapy, face to face

self-limited cognitive behavioral therapy delivered weekly for 6 weeks via tablet-based telemedicine platform

cognitive behavioral therapy, telemedicine

This study will evaluate whether a time-limited cognitive behavioral therapy (CBT) intervention in the post-treatment time period can address body image disturbance (BID) in patients with surgically-treated head and neck cancer (HNC), thereby improving BID and quality of life (QOL).

The investigators will complete a single-arm, phase II pilot study of time-limited CBT on BID in patients with surgically-treated HNC. Reliable, validated patient-reported outcome (PRO) measures of BID will be collected before, 1 month and 3 months after the CBT intervention to provide preliminary data on the effectiveness of CBT for BID in patients with surgically-treated HNC, addressing this critical knowledge gap. It is expected that time-limited CBT implemented in the post-treatment period will decrease BID and improve QOL in affected patients.

Building a Renewed ImaGe After Head & Neck Cancer Treatment

Change in shame and stigma will be measured using the Shame and Stigma Scale, a 20-item, validated tool that measures shame with appearance, stigma, regret, and social/speech concerns in patients with HNC.

Change in Depression and Anxiety will be measured using Patient-Reported Outcomes Measure Information System (PROMIS), a validated questionnaire developed by the NIH for evaluating health-related quality of life.

Social roles and isolation will be assessed by Patient-Reported Outcomes Measure Information System (PROMIS) measures, a validated questionnaire developed by the NIH for evaluating health-related quality of life.

This outcome will be measured by the Performance Status Scale for Head \& Neck Cancer, which assesses performance in domains of eating, speech, and diet.

We will collect data from patients to understand why they chose face-face CBT versus telemedicine.

To better understand patient experiences with BID not captured in the questionnaires as well as their experiences with CBT, we will perform semi-structured interviews. Participants will be asked to 1) discuss their preferences about the timing, format and content of the CBT sessions 2) describe their program experiences and offer recommendations to improve delivery, and 3) and assess feasibility and acceptability of the intervention. This mixed methods approach will allow for an in-depth exploration of patient experiences, help refine the study intervention, and inform intervention implementation for future studies.

Change in body image disturbance will be measured using Body Image Scale (BIS) scores from before and 3 months after intervention. The BIS has been validated in oncology patients and is the most widely used scale for BID in oncology. It is a 10-item measure that is scored on a 4-point Likert scale; higher scores indicate greater body image dissatisfaction. It addresses the affective, cognitive, and emotional aspects of body image. There are no subscales.

Body image investment (i.e. the importance and influence of appearance) will be measured using the Appearance Schemas Inventory-Revised (ASI-R). This 20-item measure is scored using a 5-point Likert scale with greater scores indicating greater body image investment. There are no subscales.

Change in Body Image Coping strategies will be measured using the Body Image Coping Strategies Inventory (BICSI), a validated measure used to assess cognitive and behavioral responses to manage threats to body image. The subscales are "Appearance Fixing" (10 specific items on the scale), "Avoidance" (8 specific items on the scale), and "Positive Rational Acceptance" (11 items on the scale). Each subscale score is calculated as the mean of the items within that subscale.

We will employ the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30/H\&N35 module to evaluate quality of life (QOL). The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials.

Medical University of South Carolina

Associate Professor, Department of Otolaryngology

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

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

BRIGHT is a manualized theory-based tele-CBT intervention consisting of 6 weekly 60-minute sessions. BRIGHT is delivered one-on-one by a licensed clinical psychologist at each site via standard video tele-CBT platform. BRIGHT session topics include (1) psychoeducation about the cognitive model of body image, (2) self-monitoring about thoughts, feelings, and body image behaviors, (3) cognitive restructuring to identify and challenge unhelpful automatic HNC body image thoughts, (4) positive body image coping strategies, (5) social support and identifying personal value, and (6) thinking ahead and planning for setbacks.

BRIGHT

AC is a manualized video-tele-supportive care intervention that addresses non-body image aspects of HNC survivorship. Identical to BRIGHT, AC consists of 6 weekly 60-minute sessions delivered by a trained empathic interventionist via standard video-telemedicine platform. AC session topics include (1) Introduction to HNC survivorship, (2) Post-Treatment Side Effects (3) Psychosocial Aspects of HNC, (4) Health Promotion and Nutritional Challenges, (5) Financial Distress and Return to Work, and (6) Cancer Recurrence. AC controls for professional attention (i.e., ensuring that findings are not driven by simply interacting with an empathic interventionist), common factors, dose, and delivery method while not providing the active, behavior change mechanism in BRIGHT.

Attention Control

Evan M Graboyes, MD

Taylor McLeod, MPH

Steven Chang, MD

Patrik Pipkorn, MD, MSCI

Evan M Graboyes, MD, MPH

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).

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 the Medical University of South Carolina (MUSC), Washington University School of Medicine (WUSM), and Henry Ford Health (HFH) 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.

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

A Multi-Site, Parallel-Group, Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) With Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors

Research materials will include baseline data and study outcomes from trial participants. Data will be raw or minimally processed.

Data will be available following final database lock, reporting to clinicaltrials.gov, and presentation and publication of study findings describing key primary and secondary objectives.

De-identified data available will be available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data sharing will comply with laws, regulations, and policies privacy governing data derived from human subjects.

The IMAGE-HN is a 24-item, validated patient-reported outcome measure (PROM) of HNC-related BID. Items are rated on a 5-point Likert scale from 'Never' (0) to 'Always' (4). The total global score is calculated by summing item responses across 21 items (all items except 3, 4, and 19). Total IMAGE-HN scores on the global domain (21 questions) range from 0-84; higher scores indicate worse HNC-related BID. An IMAGE-HN score of \> 22 indicates clinically-significant HNC-related BID and a change in IMAGE-HN score of \> 9 points is clinically meaningful.

The Shame and Stigma Scale is a 20-item, validated, unidimensional PROM that measures four domains (shame with appearance, stigma, regret, and social/speech concerns) in patients with HNC over the prior 7 days. Items are rated on a 5-point Likert scale from 'Never' (0) to 'All the time' (4). The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored). Shame and Stigma Scale scores range from 0-80; higher scores reflect worse HNC-related shame and stigma.

The PROMIS SF v1.0-Depression 8a is an 8-item validated measure developed by the NIH to assess patient-reported negative mood, views of self, and decreased positive affect and engagement. Responses rate the strength of agreement with statements about depressive symptoms using a scale that ranges from 1-5. The total raw score is calculated by summing the individual responses. The PROMIS SF v1.0-Depression 8a raw score ranges from 8-40; a higher score reflects more severe depressive symptoms. The PROMIS SF v1.0-Depression 8a total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

The PROMIS SF v1.0-Anxiety 8a is an 8-item, validated, developed by the NIH to assess patient-reported fear, worry, and hyperarousal. Responses rate the strength of agreement with statements about anxiety symptoms using a scale that ranges from 1-5. The total raw score is calculated by summing the individual responses. The PROMIS SF v1.0-Anxiety 8a raw score ranges from 8-40; a higher score reflects more severe anxiety symptoms. The PROMIS SF v1.0-Anxiety 8a total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

The Beck Scale for Suicidal Ideation is a 21-item, validated, unidimensional rating scale that measures the current intensity of patients' specific attitudes, behaviors, and plans to commit suicide on the day of the interview. Each item consists of three options graded according to suicidal intensity on a 3-point scale ranging from 0 to 2. The ratings for the first 19 items are summed to yield a total score, ranging from 0 to 38. Higher scores represent more severe suicidal ideation.

PROMIS SF v2.0-Ability to Participate in Social Activities 8a is an 8-item, validated, unidimensional measure of patient-reported perceptions of participation in social activities. Items are scored using a 5-point Likert scale from 'Never' (1) to 'Always' (5). The total raw score is calculated by summing the individual responses. The total raw score ranges from 8-40; a higher score reflects more severe inability to participate in social activities. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

The EORTC QLQ-Head Neck 35 Trouble with Social Eating Subscale is a 4-item, validated measure of trouble with social eating for patients with HNC. The subscale is composed of QLQ-H\&N35 items 19-22. Items are scored using a 4-point Likert scale from 'not at all' (0) to 'very much' (3). The total score is calculated by summing the individual responses. Total subscale scores range from 0-12; higher scores reflect more trouble with social eating.

The EORTC QLQ-HN35 Trouble with Social Contact Subscale is a 5-item, validated measure of trouble with social contact for patients with HNC. The subscale is composed of QLQ-H\&N35 items 18, 25-28. Items are scored using a 4-point Likert scale from 'not at all' (0) to 'very much' (3). The total score is calculated by summing the individual responses. Total subscale scores range from 0-15; higher scores reflect more trouble with social contact.

The BICSI is a 29-item, validated measure of the cognitive and behavioral responses to manage threats to body image. BICSI contains three sub-domains; (1) appearance fixing (altering appearance by covering, camouflaging, or correcting the perceived defect), (2) avoidance (an attempt to escape or avert stressful body-image situations), and (3) positive rational acceptance (acceptance of the challenging event and positive self-care or rational self-talk about one's appearance). Items are scored on a 4-point Likert scale from 'Definitely not like me' (0) to 'Definitely like me' (3). The score for each subscale is calculated by summing the values for the individual questions and thus ranges as follows: Appearance fixing (0-30), Avoidance (0-24), and Positive rational acceptance (0-33). For each subscale, higher scores indicate greater reliance on that type of body image coping strategy.

The Automatic Thoughts Questionnaire is a 15-item, validated, patient-reported measure of negative automatic thoughts. Items are scored using a 5-point Likert scale (1-5). The total score is calculated by summing the individual responses. Total scores range from 15-75; higher scores reflect more negative automatic thoughts.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos	NCT03131011	Breast Cancer F... Body Image Dist...	UV fluorescent ...	18 Years - 60 Years	CancerCare Manitoba
Building a Renewed ImaGe After Head & Neck Cancer Treatment	NCT03518671	Head and Neck S... Body Image Dist...	cognitive behav... cognitive behav...	18 Years -	Medical University of South Carolina
Building a Renewed ImaGe After Head & Neck Cancer Treatment	NCT03518671	Head and Neck S... Body Image Dist...	cognitive behav... cognitive behav...	18 Years -	Medical University of South Carolina
Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos	NCT03131011	Breast Cancer F... Body Image Dist...	UV fluorescent ...	18 Years - 60 Years	CancerCare Manitoba
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT	NCT05442957	Head and Neck C... Body Image Dist... Body Image Survivorship Psychosocial Im... Mental Health I...	BRIGHT Attention Contr...	18 Years -	Medical University of South Carolina
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT	NCT05442957	Head and Neck C... Body Image Dist... Body Image Survivorship Psychosocial Im... Mental Health I...	BRIGHT Attention Contr...	18 Years -	Medical University of South Carolina

Spots Global Cancer Trial Database for body image disturbance