Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Cognitive Dysfunction

Breast Diseases

Skin Diseases

The combine exercise intervention will consist of three 30-minute, supervised, remotely-delivered resistance training classes as well as three 30-minute, unsupervised aerobic training (i.e., walking) items each week. Participants will also participate in bi-weekly, 30-40 minute, remotely-delivered behavioural counselling sessions delivered via videoconferencing (i.e., Zoom). The program will be taught by a Registered Kinesiologist via videoconferencing (i.e., Zoom). Participants will be asked to participate in the intervention for 8 weeks.

The active control group will participate in three 30-minute, supervised, remotely-delivered classes targeting balance and flexibility. The program will be delivered at a low-intensity by a Registered Kinesiologist via videoconferencing (i.e., Zoom). Participants will be asked to participate in the program for 8 weeks.

The combine exercise intervention will consist of three 30-minute, supervised, remotely-delivered resistance training classes as well as three 30-minute, unsupervised aerobic training (i.e., walking) sessions each week. Participants will also participate in bi-weekly, 45-60 minute, remotely-delivered, group-based behavioural counselling sessions delivered via videoconferencing (i.e., Zoom). Participants will be asked to participate in the intervention for 8 weeks.

Combined Exercise + Behavioural Counselling

Active Control

Linda Trinh, PhD

Women living with and beyond breast cancer are at a heightened risk for experiencing adverse mental health outcomes and declines in cognitive function following chemotherapy treatment. Women living with and beyond breast cancer have reported increased levels of anxiety and depression during the COVID-19 pandemic which may have significantly impacted their quality of life (QoL). Physical activity (PA) may be used to manage mental health and improve cognitive function in women living with and beyond breast cancer. Research is needed to assess the feasibility of a supervised, remotely delivered, combined (i.e., aerobic + resistance) exercise program to improve cognitive function and manage adverse mental health in women living with and beyond breast cancer. This study will pilot an 8-week, remotely delivered, combined (i.e., aerobic + resistance) exercise and behavioural counselling intervention on cognitive function and mental health outcomes (i.e.,anxiety, depression, self-efficacy and self esteem) in women living with breast cancer who received chemotherapy treatment within 12-48 months.

Women living with and beyond breast cancer who received chemotherapy treatment are at a heightened risk for experiencing adverse mental health outcomes (i.e., anxiety, depression, self-efficacy and self esteem) and declines in cognitive function (i.e., impairments to memory, learning, concentration, reasoning, executive function, attention, processing speed and/or visual-spatial skills deficits) compared to those without a history of cancer. These effects may be worsened among those who received chemotherapy treatment and may persist for up to 5 and 20 years following chemotherapy treatment completion, respectively. The COVID-19 pandemic has exacerbated existing adversities in the mental health of women living with and beyond breast cancer due to reduced social opportunities, greater sedentary time, fear of susceptibility to the virus and barriers to in-person support services. Physical activity (PA) may be used to manage mental health adversities and improve QoL among women living with and beyond breast cancer. In addition, preliminary evidence has demonstrated the potential mediating effect of PA on cognitive impairments among women living with and beyond breast cancer. Remote-based interventions could be an effective option to increase PA during the COVID-19 pandemic while maintaining physical distancing protocols. In addition, the combination of exercise with group-based counselling has been found to be feasible and provide favourable improvements in depression, self-efficacy, social support, and quality of life and long-term PA maintenance among women living with and beyond breast cancer, compared to exercise interventions alone. However, no studies have evaluated the feasibility and impact of a supervised, remotely delivered, combined (i.e., aerobic and resistance) exercise + behaviour counselling program on mental health and cognitive function in women living with and beyond breast cancer following chemotherapy treatment. Using a mixed-method approach, this study will address these gaps by evaluating the feasibility of a supervised, remotely delivered combined (i.e., aerobic and resistance) exercise and behavioural counselling program for mental health and cognitive function in women living with and beyond breast cancer. This project is necessary given the remote-based format of exercise delivery that has been adopted because of the COVID-19 pandemic and the need for programs to be adapted to an environment that is safe and reliable to deliver to women living with and beyond breast cancer.

Participants will be randomized to one of two conditions: combined exercise (aerobic + resistance training) or stretching/toning (active control). They will receive a home-based program lasting 1 hour on 3 days per week for 12 weeks. Randomization will be performed using a computer-generated program in blocks of four for even distribution between study conditions. BCS will be assigned in a 1:1 ratio to one of two study conditions, stratified by treatment type (anthracycline vs. non-anthracycline chemotherapy; hormonal vs. no hormonal therapy).

The participants will only be aware that the researchers are comparing two exercise conditions and therefore will be blinded to the study hypotheses.

A Combined Exercise Training Program for Women Living With Breast Cancer

A Remotely-Delivered, Combined Exercise Training Program for Cognitive Function in Women Living With and Beyond Breast Cancer: A Feasibility Study

Participant enrolment rate will be one measure of feasibility. This will be calculated by measuring the amount of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility.

Adherence rate of participants to the intervention, will be one measure of feasibility. This will be measured by calculating the number of exercise sessions participants attend, divided by the total number of exercise sessions that took place in the intervention.

Attrition will be one measure of feasibility. This will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who completed the entirety of the intervention

Burden and satisfaction scores will be one measure of feasibility. This will be assessed using a researcher-generated 15-item questionnaire that asks participants about their experience with the intervention and assessments. Participants will rate items using a 5-point Likert scale (1= 'strongly disagree', 5 = 'strongly agree').

Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury that occurs during the exercise classes.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Flanker Inhibitory Control and Attention Test tests the ability to inhibit visual attention to irrelevant task dimensions. A scoring algorithm integrates accuracy and reaction time yielding scores from 0 to 10. There are 40 trials and the average time to complete the task is 4 minutes.To interpret individual performance, one can evaluate all three types of scale scores in which higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Picture Sequence Memory Test involves a presentation of stimuli which are pictured objects and activities, thematically related but with no inherent order. For each trial, pictures appear in the center of the screen and then are moved 1 at a time into a fixed spatial order, as an audio file simultaneously describes the content of each. The score is based on the cumulative number of adjacent pairs of pictures remembered correctly over 3 learning trials. The test takes approximately 10 minutes. Higher scores indicate better episodic memory.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Picture Vocabulary Test involves single words that are presented via an audio file, paired simultaneously with 4 screen images of objects, actions, and/or depictions of concepts. The participant will pick the picture that matches the spoken word. Total administration time is approximately 5 minutes. To interpret individual performance, one can evaluate all three types of scale scores. A participant's age-adjusted scale score at or near 100 indicates vocabulary ability that is average for the age level. Scores around 115 suggest above-average vocabulary ability, while scores around 130 suggest superior ability - in the top 2 percent nationally for age, based on Toolbox normative data.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). This composite includes the Picture Vocabulary and Reading Tests. This composite score is derived by averaging the normalized scores of each of the measures, and then deriving scale scores based on this 14 new distribution. An Age-Adjusted Scale Score, Fully Adjusted Scale Score, Unadjusted Scale Score and Age-Adjusted National Percentile are provided for the Crystallized Cognition Composite. Crystallized Cognition Composite is a more global assessment of individual and group verbal reasoning. Higher scores indicate higher levels of functioning.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Auditory Verbal Learning Test (Rey) measures immediate recall. Unrelated words presented via audio recording and participant recalls as many as possible. he Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores reflecting better episodic memory.

Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). The Oral Symbol Digit Test measures speed of processing. Symbols on the screen are associated with a number, then presented with symbols without numbers. The Oral Symbol Digit Test is scored as the number of items answered correctly in 120 seconds (possible range is 0-144).Higher scores indicate better processing speed.

Measured using the Hospital Anxiety and Depression Scale (HADS), which is a 14-item questionnaire divided into two subscales of seven items each measuring anxiety (HADS-A) and depression (HADS-D). Two sub-scores (HADS-A and HADS-D) will be calculated with scores that vary from 0 to 21. Higher scores indicate more anxious/depressive symptoms (Zigmond \& Snaith, 1983).

Self-efficacy will be measured using the Breast Cancer Survivor Self Efficacy Scale. This is an 11-item Likert scale through which participants rate their responses from 1'strongly disagree' to 4, 'strongly agree'. A higher total score indicates better self efficacy.

Self-esteem will be measured pre-intervention and post-intervention (i.e., 8 weeks) using the Rosenberg Self-Esteem scale. This is a 10-item, likert style scale through which participants rate their responses from 1, 'strongly disagree' to 5, 'strongly agree'. Higher total scores indicate better self-esteem.

Objectively assessed PA was measured using Actigraph GTX3+ accelerometers (Pensacola, FL). Participants will wear the accelerometer on their non-dominant hip during waking hours for 7 consecutive days. Data will be downloaded in 60-s epochs and processed and converted to mean counts per minute in ActiLife software package (Version 6; Actigraph) to estimate daily minutes of light (101-1951 counts min-1), moderate (1952-5724 counts min-1), vigorous (≥ 5725 counts min-1), and total moderate-to-vigorous physical activity (MVPA; ≥ 1952 counts min-1) based on established cut-points (Freedson, Melanson, \& Sirard, 1998). Estimated average daily minutes spent in each activity intensity category was calculated by dividing the number of minutes spent in each category by the total number of valid days worn.

The researcher will conduct semi-structured qualitative interviews over videoconferencing that will ask participants about their experience with the study and intervention, including enjoyment, potential barriers faced, and how they felt mentally and cognitively during and after the intervention.

Therapeutic alliance will be measured using the Working Alliance Inventory Short Revised (WAI-SR). This is a Likert scale through which participants rate their responses from 1, 'seldom', to 5, 'always'. A higher total score indicates better therapeutic alliance.

University of Toronto

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Clinical standard of care at time of study

Multiple component intervention based in the unified theory of behavior

Intervention

Partial intervention (full intervention minus cultural-specific component)

Active control

Carmen R Breitkopf, PhD

This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations.

Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and treatment of precursor lesions. However, 20% to 70% of women in the United States who are told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for follow-up care. This is a problem especially among minorities and women of lower socioeconomic status. The purpose of this part of the protocol is to test a theory-based intervention designed to improve adherence to follow-up among women who experience an abnormal Pap test. The intervention is a message, delivered over the telephone by a nurse, at the time Pap test results are given to patients. The investigators propose to randomize women who experience an abnormal Pap test to one of three groups: (1) targeted cultural belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge + importance (active control), or (3) standard care only (passive control). All three groups will receive standard care, which is to notify women by telephone of their abnormal results and provide instructions for follow-up. Women assigned to the intervention group also will receive a cultural belief component consistent with their racial/ethnic group, detailed information about follow-up procedures and the consequences of not returning for follow-up, and information regarding the importance of adhering to recommendations, particularly for "low grade" abnormalities. Women assigned to the active control group will receive a nontargeted belief component, plus procedural knowledge and a message on the importance of follow-up. Adherence to initial follow-up will be the primary outcome. Other behavioral outcomes, such as delayed care and completeness of care, also will be assessed over an 18-month interval by chart review. Additionally, the investigators will evaluate psychological outcomes including anxiety and distress. Finally, the investigators will examine the grade of abnormality (low versus high) as an effect modifier. The investigators anticipate that this research will result in an intervention that will improve several important behavioral and psychological outcomes related to abnormal Pap test results. The intervention is guided by a general integrative theoretical framework; therefore, this research will evaluate an intervention strategy that recognizes the importance of targeting culturally relevant beliefs about follow-up and key determinants of behavior (knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test results. Ultimately, the objective of this research is to improve adherence to follow-up among low-income, minority women who are at particular risk of developing cervical cancer.

Intervention to Improve Follow-up of Abnormal Pap Test

Attendance at initial appointment to follow-up abnormal Pap test result

State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)

National Cancer Institute (NCI)

The University of Texas Medical Branch, Galveston

Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Intervention: Multiple component intervention based in the unified theory of behavior

nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Active control: Partial intervention (full intervention minus cultural-specific component)

Standard Care Only

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Carmen Radecki Breitkopf

Adherence to Initial Follow-up (Yes/no)

non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Active control: Partial intervention (full intervention minus cultural-specific component)

Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.

State Trait Anxiety Inventory (STAI)-State Scale

Overall Study

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Overweight

Weight Loss

Obesity

Body Weight

Overnutrition

Nutrition Disorders

Body Weight Changes

A weight management intervention, namely Lose Little, Live Longer (L4), is recently developed to assist overweight cancer survivors in weight loss through lifestyle modification including improved dietary quality and enhanced physical activity levels. Its underlying theoretical framework is principally derived from Social Cognitive Theory (SCT), which have been widely used in health behavioural change interventions.

A video-based intervention is selected as a low-touch alternative with expected benefits beyond a no treatment control. Participants allocated to the active control arm will receive five educational videos designed to promote a balanced diet and reinforce regular physical activity, weekly through instant messaging.

Participants allocated to the waitlist control arm will receive a set of pamphlets with generic, knowledge-based dietary and physical activity information. All pamphlets are developed based on the self-management framework. Participants in this arm will be arranged to attend to the L4 intervention upon completion of the study.

he key goals of the intervention are to: (i) teach knowledge of weight loss benefits and health risks of obesity, (ii) offer skill-based dietary and physical activity advice, (iii) develop an achievable weight loss goal and plan, (iv) enhance weight management self-efficacy, (v) provide access to exercise equipment and resources, and (vi) teach strategies for managing cravings. The L4 intervention is a therapist- delivered intervention involving a registered dietitian and a cancer exercise specialist. Participants allocated to the intervention arm will be provided with a schedule to attend the L4 intervention within four weeks post-baseline via phone. They will receive five intervention sessions (120 min each) on a weekly basis, and will be given home-based practices and reading to practice the skills learnt in each session. The intervention sessions will be delivered in a group format with a maximum of 5 individuals per group, which is likely to enhance accountability.

L4 weight management intervention

A video-based intervention is selected as a low-touch alternative with expected benefits beyond a no treatment control. Participants allocated to the active control arm will receive five educational videos designed to promote a balanced diet and reinforce regular physical activity, weekly through instant messaging, and be encouraged to follow the advice covered in the videos. The materials will be developed based on the existing dietary and physical activity guidelines for cancer survivors. Participants in this arm will be arranged to attend to the L4 intervention upon completion of the study.

Danielle Ng, PhD

This study aims to conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the weight management intervention on anthropometric measures (body weight and BMI), dietary quality, physical activity levels, physical and psychosocial functioning, self- efficacy for weight loss and quality of life.

The primary aim of the proposed study is to assess the feasibility and acceptability of conducting a randomized controlled trial (RCT) that evaluates an adaptive weight management intervention, tailored to Chinese cancer survivors with overweight/obesity after the completion of cancer survivorship care, to improve anthropometric measures (body weight and BMI), dietary quality, physical activity levels, physical and psychosocial functioning, self-efficacy for weight loss and quality of life. According to the Consolidation Standards of Reporting Trials (CONSORT) guidelines for reporting feasibility trials, hypothesis setting for a feasibility trial is not recommended, given that pilot trials are often underpowered to detect difference which instead should be the aim of the main trial.

This is a 3-arm feasibility trial study with one intervention group, one active control group and one waitlist control group. Computer-generated block randomization sequences will be generated by a statistician who is blinded to the identity of participants prior to the start of the trial. A block randomisation structure with randomly permuted block sizes of 3 and 6 will be used to reduce selection bias and ensure close balance of the numbers in each arm. The serially labelled opaque sealed envelope method will be used for randomisation.

The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to intervention or active control or waitlist arms.

The participants are masked in terms of not knowing that the intervention are hypothesized to yield larger effects than the others (i.e. controls).

A Weight Management Intervention for Overweight Chinese Cancer Survivors

Lose Little, Live Longer: A Randomised Controlled Feasibility Trial on a Diet-plus-exercise Weight Management Intervention for Overweight Chinese Cancer Survivors

All IPD that underlie results in a publication will be available from the PI upon reasonable request.

number of participants consent and being randomized/number of eligible patients x 100

number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100

number of participants who complete the intervention/number of being allocated to attend the intervention x 100

number of participants with completed datasets for outcome measures/number of participant enrolled x 100

Weight will be assessed in light clothing and without shoes using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). To minimise measurement error, weight will be measured twice with accepted values within 0.1kg. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.

BMI will be assessed in light clothing and without shoes using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). For the calculation of BMI (kg/m2), height will be measured to 0.01cm using a portable calibrated stadiometer (SECA Stadiometer). To minimise measurement error, weight and height will be measured twice with accepted values within 0.1kg and 0.3cm, respectively. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.

Self-efficacy for weight loss will be assessed using the 11-item Physical Activity and Nutrition Self-Efficacy (PANSE) scale. Each item is rated on a 9-point Likert scale ranging from 1 "not at all confident" to 9 "highly confident". Total score range is 11 to 99, with higher scores indicative as greater perceived self-efficacy for weight loss. The PANSE has demonstrated strong internal consistency (Cronbach α = .89), convergent validity, and test-retest reliability.(18)

Dietary quality will be assessed with a three-day dietary record. Participants will be instructed to record their diet for three consecutive days including two weekdays and one weekend day, and not to alter their diet deliberately. All dietary records will be coded for the following food groups: (1) total grains, (2) refined grains, (3) whole grains, (4) fruits, (5) vegetables, (6) pork, (7) beef and other red meats, and (8) processed meats.

Skin carotenoid status, a biomarker of fruit and vegetable intake, will be measured by the Veggie Meter. The Veggie Meter is a non-invasive tool that utilizes the optical method of reflective spectroscopy upon pressure of the fingertip on the lens to measure skin carotenoid status. Three consecutive measurements will be taken per participant without removing the finger from the lens, and the average of the three ranging from 0-800 will be used with higher scores indicating higher fruit and vegetable intake.

Physical activity level will be assessed using the Global Physical Activity Questionnaire (GPAQ) developed by World Health Organization. The GPAQ measures how many days per week (0-7 days) and how many times in minutes per day (0-1440 minutes) spent doing different types of physical activity.

The generic EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire evaluates five dimensions including mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale (1 = no problem; 2 = slight problem; 3 = moderate problem; 4 = severe problem; 5 = extreme problem).

Cancer-specific quality of life will be assessed using the standard Chinese version of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30), which measures five function domains (physical, role, emotional, cognitive and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptoms items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulties, using a 4-point Likert scale ranging from 0 "Not at all" to 3 "Very much"

Physical and psychological symptom distress will be measured using the 10-item Edmonton Symptom Checklist (ESAS).The ESAS comprises 10 symptoms commonly observed in cancer patients (including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep difficulty) that assess three components: physical, emotional and total symptom burden.

Health and Medical Research Fund

The University of Hong Kong

Head and Neck Neoplasms

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. AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship.

BRIGHT

AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session (Table 5) is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship.

Evan M Graboyes, MD, MPH

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.

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.

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.

Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0

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)

The Body Image Scale (BIS) is a validated, 10-item patient-reported outcome measure (PROM) that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.

The BIS is a validated, 10-item patient-reported outcome measure that assesses the affective, cognitive, and emotional aspects of body image due to cancer or its treatment over the prior 7 days. Responses include 'not at all', 'a little', 'quite a bit', and 'very much', and are scored from 0-3, respectively. Total BIS scores can range from 0-30, with higher scores indicating greater body image dissatisfaction.

The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related body image distress (BID) due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.

The IMAGE-HN is a psychometrically sound, 24-item, multi-domain PROM consisting of 4 sub-scales and a global scale that can be used to measure key aspects of HNC-related BID due to HNC or its treatment. Responses include 'Never', 'Rarely', 'Sometimes', 'Often', 'Always', corresponding to a Likert scale of 0-4, respectively. Total IMAGE-HN scores on the global domain (21 questions) range from 0-84, with higher scores indicated greater HNC-related body image dissatisfaction.

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. Responses include 'never', 'seldom', 'sometimes', 'often', and 'all the time' and are scored 0-4, respectively. The total score is calculated by summing the individual responses (except for 4 questions which are reverse scored) and thus ranges from 0-80. Higher scores reflect greater shame and stigma from HNC.

PROMIS SF v1.0-Depression 8a is a validated, 8-item measure developed by the NIH to assess self-reported negative mood, views of self, and decreased positive affect and engagement. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). Higher scores reflect more severe depressive symptoms.

The PROMIS SF v1.0-Anxiety 8a is a validated, 8-item measure developed by the NIH to assess self-reported fear, worry, and hyperarousal46. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe anxiety.

PROMIS SF v2.0-Satisfaction with Social Roles and Activities 8a is a validated, 8-item, measure developed by the NIH to assess self-reported satisfaction with performing one's usual social roles and activities. Items are scored using a 5-point Likert scale from 'not at all' to 'very much' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect greater satisfaction with social roles and activities.

PROMIS SF v2.0-Social Isolation 8a is a validated, 8-item, measure developed by the NIH to assess self-reported perceptions of being avoided, excluded or unknown by others. Items are scored using a 5-point Likert scale from 'never' to 'always' (1-5). The total score is calculated by summing the individual responses and thus ranges from 8-40. Higher scores reflect more severe social isolation.

Medical University of South Carolina

Associate Professor, Department of Otolaryngology- Head and Neck Surgery

Per protocol, only adverse events defined as any undesirable sign, symptom, medical, psychological, social, or emotional reaction that is definitely, probably, or possibly related to the study intervention were collected,

The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist.

AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform.

AC consists of 5 weekly sessions of videos about head and neck cancer (HNC) survivorship that are delivered using a telemedicine platform.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The efficacy analysis population consisted of all eligible, randomized, evaluable patients. Patients who developed a recurrent or new primary cancer went off study per protocol and were not evaluable.

Evan Graboyes

BRIGHT is video tele-cognitive behavioral therapy delivered one-one for five weekly 60-minute sessions by a licensed clinical psychologist.

AC is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.

The efficacy analytic population consisted of all eligible, randomized, evaluable patients. Patients who developed a recurrent or new primary cancer went off study per protocol and were not evaluable.

Change in Body Image Scale Score From Baseline to 1-month Post-intervention

Change in Body Image Scale Score From Baseline to 3-months Post-intervention

Change in IMAGE-HN Score From Baseline to 1-month Post-intervention

Change in IMAGE-HN Score From Baseline to 3-months Post-intervention

Change in Shame and Stigma Scale Score From Baseline to 1-month Post-intervention

Change in Shame and Stigma Scale Score From Baseline to 3-months Post-intervention

Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 1-month Post-intervention

Change in PROMIS SF v1.0-Depression 8a Score From Baseline to 3-months Post-intervention

Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 1-month Post-intervention

Change in PROMIS SF v1.0-Anxiety 8a Score From Baseline to 3-months Post-intervention

Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 1-month Post-intervention

Change in PROMIS SF v2.0- Satisfaction With Social Roles and Activities 8a Score From Baseline to 3-months Post-intervention

Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 1-month Post-intervention

Change in PROMIS SF v2.0-Social Isolation 8a Score From Baseline to 3-months Post-intervention

Active Control (AC) is a tele-supportive care intervention delivered one-on-one for five weekly sessions via video telemedicine platform.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Combined Exercise Training Program for Women Living With Breast Cancer	NCT05704855	Breast Cancer	Combined Exerci... Active Control	40 Years - 65 Years	University of Toronto
Intervention to Improve Follow-up of Abnormal Pap Test	NCT00575510	Cervical Cancer	Intervention Active control	18 Years - 55 Years	The University of Texas Medical Branch, Galveston
A Weight Management Intervention for Overweight Chinese Cancer Survivors	NCT06209996	Cancer Weight Loss Overweight and ...	L4 weight manag... Active control	18 Years -	The University of Hong Kong
A Combined Exercise Training Program for Women Living With Breast Cancer	NCT05704855	Breast Cancer	Combined Exerci... Active Control	40 Years - 65 Years	University of Toronto
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0	NCT03831100	Head and Neck C...	BRIGHT Active Control	18 Years -	Medical University of South Carolina

Spots Global Cancer Trial Database for active control