Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients in the experimental group will undertake a 12-week (semi)automated telecoaching program with the aim of enhancing their physical activity. The program uses a Fitbit wearable and a smartphone application that is developed for and tested to be effective for patients with COPD.

The program includes

1. one-to-one semi-structured interview with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favourite activities, and (coping) strategies to become more active resulting in an individual action plan;
2. step counter (Fitbit) providing direct feedback which automatically sends data to the smartphone via blue-tooth. Patients will be asked to wear this step counter every day during the intervention;
3. smartphone coaching application (mPAC), installed on a smartphone and linked to the step counter, will provide automated coaching by displaying an individual activity goal (expressed as daily step count) and daily and weekly feedback on the performance (steps) of the patient.
4. phone calls by the coaches initiated in pre-defined situations (non-compliance with wearing the step counter, failure to transmit the data, failure to progress).

Evidence-based behaviour change techniques will be implemented.

Physical activity tele coaching program

Eva Arents, MSc

Maarten Criel, MD

Sarah Haesevoets, MSc

Chris Burtin, PhD

Karin Pat, MD

Eva Arents

Eva Arents, Msc

Heleen Demeyer, PhD

Dieter Stevens, MD

Lander Van Acker, MD

Ingel Demedts, MD, PhD

The goal of this randomized controlled clinical trial is to test a 12-week physical activity telecoaching program for NSCLC patients after surgery.

The main question it aims to answer is:

What is the effectiveness and acceptability of a 12-week (semi)automated low-to-moderate intensity PA tele coaching program on physical activity (mean steps per day) in resectable (stage I-IIIA) NSCLC patients after lung surgery, as compared to usual care?

Patients with NSCLC will be enrolled in the study from 1 month postoperatively up to 1 year postoperatively. They will be randomized in either the intervention group or the control group.

Patients randomized in the intervention group will be asked to enter a 12-week physical activity telecoaching program with the aim to enhance their physical activity. The telecoaching programs consists of 4 pilars:

1. A wearable (Fitbit) to measure and give feedback on their daily step count.
2. A smartphone coaching application, installed on a smartphone and linked to the wearable, providing automated coaching by displaying an individual activity goal (expressed as daily step count) and daily and weekly feedback on the performance (steps) of the patient.
3. A one-to-one semi-structured interview with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favourite activities, and (coping) strategies to become more active resulting in an individual action plan.
4. Phone calls by the coaches initiated in pre-defined situations (non-compliance with wearing the step counter, failure to transmit the data, failure to progress).

Patients randomized in the control group will remain their usual care and will not enter the 12-week physical activity telecoaching program.

Lung cancer is the most commonly diagnosed cancer in men and the third most commonly diagnosed cancer in women worldwide. In Belgium specifically 8874 new cases of lung cancer were diagnosed in 2019 with a poor prognosis (five-year survival rate of 11% to 18%). Non-small cell lung cancer (NSCLC) is the most common subtype of lung cancer, accounting for approximately 85% of all cases. Survival from NSCLC is considerably better than for small-cell lung cancer (SCLC) and depends on the stage of the disease. Complete surgical resection (with or without adjuvant systemic therapy) is the preferred option for patients with resectable (stage I-IIIA) NSCLC.

Existing evidence supports the many benefits, such as blood pressure lowering, higher VO2max levels, lower mortality risk, etc. of physical activity (PA, i.e. all activities that a person performs during a day) among lung cancer survivors. PA however, is proven to be reduced in these patients. A lack of PA can contribute to the perceived symptom burden and decreased health-related quality of life in patients cured from or being treated for NSCLC.

Improving PA is a potential strategy to improve quality of life and symptom experience in these patients. This can possibly be achieved by implementing a (semi-)automated PA tele coaching program to improve PA. The efficacy and effectiveness of implementing such PA tele coaching program for operatively treated NSCLC patients will be assessed in the present study.

A previous study already showed the feasibility and effectiveness of a (semi)-automated tele coaching program (application installed on a smartphone device with real time feedback and motivational messages) and a step counter (Fitbit) providing direct feedback on total daily number of steps, walking time, time in at least moderate PA and movement intensity during walking in patients with chronic obstructive pulmonary disease (COPD).

However, studies investigating the implementation of this application in patients with NSCLC are lacking. Whereas it is clear that research on other populations cannot be generalized to cancer survivors, the investigators are convinced that this previous expertise in COPD can be translated to this population.

Patients who had lung surgery for resectable NSCLC (stage I-IIIA) one to twelve months before inclusion, with or without (neo-)adjuvant chemotherapy/radiotherapy/immunotherapy will be randomized in the intervention group or control group. Patients receiving active immunotherapy following adjuvant chemotherapy can also be included.

The intervention group will receive a 12-week individualized physical activity tele coaching program. Patients randomized in the control group will remain their usual care and will not enter the 12-week physical activity telecoaching program.

After the first 12 weeks, both groups will be followed up for another 12 weeks and also up to 1 year after randomisation.

90 Patients will be included. Patients will be randomised into the intervention or control group. Random blocks of 4 and 6, stratified by adjuvant systemic treatment (yes vs no) and centre of inclusion (Gent, Hasselt) will be used. The upcoming allocation will be concealed using the REDCap randomization module.

The aims of the present study are:

1. Primary objective:

   To investigate the effectiveness and acceptability of a 12-week (semi)automated low-to-moderate intensity PA tele coaching program on physical activity (mean steps per day) in resectable (stage I-IIIA) NSCLC patients after lung surgery, as compared to usual care.
2. Secondary objectives:

A. To investigate the effectiveness of a 12-week (semi)automated low-to-moderate intensity PA tele coaching program on physical activity (MVPA, daily walking time, movement intensity during walking, sedentary time, intensity measured as VMU relative to the VMU during 6MWT), functional exercise capacity, symptoms (dyspnea, fatigue, anxiety), quality of life, quadriceps muscle force and functional performance in resectable (stage I-IIIA) NSCLC patients after lung surgery.

B. To investigate the long-term (24 weeks after randomization) effect of a 12 week (semi)automated low intensity PA tele coaching program on physical activity, functional exercise capacity, symptoms (dyspnea, fatigue, anxiety), quality of life, quadriceps muscle force and functional performance in resectable (stage I-IIIA)NSCLC patients after lung surgery.

C. To explore the intensity of physical activity level relative to the maximal intensity performed during a six minutes walk test and relate this to the improvements in the secondary outcomes.

D.To investigate the association between changes in PA, functional exercise capacity and health-related quality of life (SF-36, EORTC-QLQ-C30, EORTC-QLQ-LC-13) and symptoms.

Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer

Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer: a Randomized Controlled Trial

by having access to the patients' file for 2years

Is there need for follow-up cancer treatment? Will be documented by having access to the patients' file for 2years

The type of follow-up cancer treatment will be documented by having access to the patients' file for 2years

All adverse events will be collected and graded based on CTCAE 5.0 with information on severity, seriousness, relatedness to the intervention and sequelae; All interactions with the smartphone application and contacts with the coaches will be logged;

An interview will be performed to ask the patient about their experience of the intervention. The interview is a one-to-one voice-recorded interview with open-ended questions, taken by the researcher.

A questionnaire will be performed to ask the patient about their experience of the intervention. The questionnaire is on paper and will be filled out by the patient.

Change in physical activity (mean steps per day), objectively measured by avalidated tri-axial accelerometer (Dynaport MoveMonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3 valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.

Change in physical activity (mean steps per day), objectively measured by avalidated tri-axial accelerometer (Dynaport MoveMonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.

Change in time in MVPA, objectively measured by avalidated tri-axial accelerometer (Actigraph) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3valid weekdays (\>8 hours of wearing time during the day) is necessary to label thisas a valid measurement.

Change in walking time, objectively measured by avalidated tri-axial accelerometer (Dynaport Movemonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3 valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.

Change in movement intensity during walking, objectively measured by avalidated tri-axial accelerometer (Dynaport Movemonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3 valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.

Change in sedentary time, objectively measured by avalidated tri-axial accelerometer (Actigraph) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3 valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.

A clinically relevant test to measure a patient's exercise capacity is the 6MWT. During this 6MWT the maximal intensity that a patient reaches during the test will be instrumented by the Actigraph. As the maximal intensity we will retrieve the mean VMU during the 6MWT. Day-by-day intensity can then be expressed as a % of this maximum.

Functional exercise capacity will be measured using a six-minute walk distance (6MWD) test. This test is a routinely used, valid, reliable and safe exercise test in patients with chronic respiratory diseases. The test is standardized in a 30m corridor and will be performed according to the protocol proposed by ERS/ATS.

Heart rate and oxygen saturation are measured before, during and after the test. Symptom scores for dyspnea and leg fatigue are assessed, at the beginning and end of the test, by the BORG scale. The 6MWD will be measured twice per visit.

Functional exercise capacity will be measured by a 1-min sit-to-stand (1MSTS) test and is a reliable, valid and responsive test for measuring functional exercise capacity in COPD patients. The 6MWD will be measured twice per visit.

The San Diego Shortness of Breath Questionnaire (SOBQ) will be used to assess self-reported shortness of breath while performing activities of daily living. Scores range from 0 (better) to 120 (worse).

Measured by Functional Assessment of Chronic Illness Treatment-Fatigue (FACIT-F). Maximum score is 160 and minimum score is 0. The higher the score, the better the quality of life.

Measured by the Depression, Anxiety and Stress scale (short-form) (DASS-21). For each scale it is needed to sum the scores for identified items. Because the DASS-21 is a short form version of the DASS (the long form has 42 items), the final score of each item groups needs to be multiplied by 2.

Interpretation of Depression score: 0-4=normal, 5-6=mild, 7-10=moderate, 11-13=severe, 14+=extremely severe.

Interpretation of Anxiety score: 0-3=normal, 4-5=mild, 6-7=moderate, 8-9=severe, 10+=extremely severe.

Interpretation of Stress score: 0-7=normal, 8-9=mild, 10-12=moderate, 13-16=severe, 17+=extremely severe.

The UCLA Loneliness Scale provides a reliable and valid assessment of loneliness across a variety of populations and data-collection methods. The total score ranges from 20 to 80. Higher scores indicate higher loneliness. The most commonly used categorization is the following: 20-34 denotes a low degree of loneliness, 35-49 a moderate degree of loneliness, 50-64 a moderately high degree of loneliness, and 65-80 a high degree of loneliness.

The European Organization for the Research and Treatment of Cancer Questionnaire and lung cancer module (EORTC QLQ-C30-LC13) is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EORTC core quality of life questionnaire. Scores for the EORTC-C30-QLQ and the lung cancer module each range from 0-100. Higher scores indicate a higher quality of life.

Measured by the 36-item Short Form Survey (SF-36). SF-36 scores range from 0 (worst) to 100 (best). Higher scores indicate a better quality of life.

The EQ-5D is a short questionnaire to assess general health status. There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). The instrument also includes a visual analogue scale (EQ-VAS) which provides a single global rating of self-perceived health and is scored on a 0 to 100 mm scale representing "the worst..." and "the best health you can imagine", respectively.

The Exercise Self-Efficacy Scale (ESES) is a scale developed to measure a person's beliefs or confidence that they can perform various physical activities and exercise on a scale of 1-4. Scores range from 10 (worst) to 40 (best).

The modified Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement \[32\]. Scores range from 17 (best) - 68 (worst).

The LIVAS is a questionnaire, tapping how a person perceives his or her physical abilities. The scale is based on the Perceived Physical Ability (PPA) scale (Ryckman et al., 1982). The questionnaire consists of 10 items, asking subjects to evaluate their physical abilities compared to other people of their own age.

The items have to be rated on a five-point scale.The scale scores therefore vary between 10 and 50. Higher scores represent more positive physical self-efficacy beliefs.

The self-Regulated Questionnaire-Exercise (SRQ-E) is a validated 16-item instrument including four regulation subscales used to assesses regulation styles (i.e., intrinsic motivation, identified regulation, introjected regulation and external regulation) in the participants. Using this instrument, participants will be asked reasons for exercising on a regular basis. There are four different types of behavioral regulation. They are external regulation, introjected regulation, identified regulation, and integrated regulation, in order from the least to the most fully internalized. Each participant gets a score on each subscale by averaging responses to each of the items that make up that subscale--for example, the average of all items representing introjected regulation would represent the score for that subscale.

Measured by Ecological Momentary Assessment (EMA) measured by Psymate 2 smartphone application

Measured by the Short Physical Performance Battery (SPPB)This test assesses lower extremity function and mobility. It consists of 3 subtests that are scored and points are added up:

1. 4-meter gait speed
2. 5 times sit to stand
3. Balance test: In this test, patients take specific positions (side by side stand, semi-tandem stand and tandem stand) for a maximum of 10 seconds after demonstration of each foot position. Progressively the foot positions become more difficult.

Rating of the SPPB: Each task is scored out of 4 (0: worst performance - 4: best performance), with a total score from the tree subtests ranging from 0 (lower level of function) to 12 (higher level of function).

Hasselt University

AZ Sint-Jan AV

AZ Delta

Ziekenhuis Oost-Limburg

Jessa Hospital

University Hospital, Ghent

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Depression

Depressive Disorder

Breast Diseases

Skin Diseases

IntelliCare is a self-guided, fully automated suite of apps designed for brief, frequent check-ins to promote skill acquisition. IntelliCare has been shown in both general deployment and human-supported trials to be efficacious in reducing symptoms of depression and anxiety.

The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.

IntelliCare is a self-guided, fully automated suite of 6 apps designed for brief, frequent check-ins to promote skill acquisition. IntelliCare has been shown in both general deployment and human-supported trials to be efficacious in reducing symptoms of depression and anxiety.

IntelliCare

The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.

Psychoeducation

The randomization of added coaching vs. no added coaching after 1 week will only be carried out in the IntelliCare group. Coaching is a human supported approach to optimizing the use and benefit of the IntelliCare apps.

Coaching

The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).

Sequential, Multiple Assignment, Randomized Trial (SMART)

Eligibility is not based on self-representation of gender identity.

Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

Evaluating a Mobile Application to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

A single questionnaire with subscales of perceived utility and perceived impact; 18 items each scored on a 0 (not at all) to 5 (very) scale

A single questionnaire that assesses barriers to program use; 32 items each scored on a 0 (not at all) to 2 (very) scale

Only those that receive the IntelliCare apps will be administered a qualitative interview that contains items assessing how the app intervention met their needs as a breast cancer survivor and possible changes to improve fit. Study staff will administer this interview on the phone. 10 questions will assess overall impressions of the IntelliCare app program. Additional questions will focus on specific apps within the IntelliCare program and how they can be tailored in future studies.

8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

9 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.

Fatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.

The Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.

The Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).

The PROMIS Global Health scale v1.2 contains 7 items that measure physical and mental health. Each question is scored on a 1-5 scale with a total score range of 7-35. Higher scores indicate better overall health.

The PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.

The UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.

The Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.

The Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Each personality domain is assessed by 2 items. Each item is scored on a 1-7 scale. Higher scores on each personality trait domain indicates higher levels of that personality trait.

The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.

Northwestern University

University of Virginia

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Written Information Prescription Technology

Written Information Prescription Technology Coaching

Receive written information on diet and exercise relevant to older men with prostate cancer

Written Information

Participants receive tailored exercise prescription and tailored diet recommendations

Prescription

Participants receive motivational text messages and can electronically log and track their exercise and diet habits

Technology

Participants receive access to an exercise and diet coach to provide advice by phone and/or email

Kerri Winters-Stone

This pilot clinical trial studies how well the True NTH Community of Wellness internet-based exercise and diet support works in improving diet and exercise habits in prostate cancer survivors. Internet-based exercise and diet support may help better control treatment-related side effects and symptoms, better overall quality of life, and lower risk factors associated with cancer progression.

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of the Community of Wellness web portal among prostate cancer survivors by conducting a randomized controlled study comparing four levels of web-based content and interaction with participants.

SECONDARY OBJECTIVES:

I. To compare efficacy of four levels of web-based content in the Community of Wellness web portal in a pilot randomized controlled trial on exercise and dietary habits, self-efficacy for behavior change, motivation for exercise, and changes in treatment-related side effects.

OUTLINE: Patients are assigned to 1 of 4 groups.

GROUP I: Patients receive "Written Information" which includes access to the TrueNTH open access portal that provides basic written information about exercise and diet.

GROUP II: Patients receive access to "Written Information + Prescription", including written information plus additional an exercise prescription and tailored diet recommendations.

GROUP III: Patients receive access to "Written Information + Prescription + Technology", including written information, exercise prescription + diet recommendation and additional technology components. Patients complete diet and exercise behavior logs and receive educational and motivational text messages about healthy diet and exercise habits.

GROUP IV: Patients receive access to "Written Information + Prescription + Technology + Coaching" and receive written information, exercise prescription + diet recommendation, technology support and a 30-minute (each) diet and exercise consultation plus the ability to receive ongoing advice from coaches via the web portal.

After completion of intervention, patients are followed up at 3 months.

Internet-Based Exercise and Diet Support in Prostate Cancer Survivors

True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors

Measured as ability to recruit target sample size within one year

Measured as the % of men who complete post-intervention and follow-up measures out of the total # of men enrolled

Measured as the # of times that a man visits the portal over three months

CHAMPS estimates total weekly energy expenditure (in kilocalories per week) from low to vigorous intensity physical activities for older adults.

This 132-item survey assesses dietary intake over the past month in categories from "never or less than once per month" to "6 or more times per day" and supports examining major food and nutrient categories of the U.S. diet.

A 6-item measure of Self-efficacy for Exercise will be used. Summed scores range from 6-30, and higher scores indicate higher self-efficacy.

This 5-question measure asks the person to select one description, from a choice of five, which describes his current activity behavior.

The Charlson Comorbidity Index is a weighted index to predict mortality. Scores range from 0-37, with higher scores indicating more chronic medical conditions.

Diet self-efficacy will be measured by having participants rate their confidence in performing each recommended task (e.g., two more servings of cooked tomatoes per week) using a Likert scale.

This self-report questionnaire assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.

MAX-PC is an 18 item scale to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence.

PROMIS - Fatigue evaluates self-reported symptoms of fatigue, from mild subjective feelings of tiredness to an overwhelming sense of exhaustion over the past seven days.

BREQ2 measures the continuum of behavioral regulation in exercise psychology research. This questionnaire concerns the reasons why a person exercises regularly, works out, or engages in other such physical activities. It is structured so that it asks one question and provides responses that represent external regulation, introjected regulation, identified regulation, and intrinsic motivation.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients and has five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Scores range from 0-100, with higher functional scale scores indicating a higher level of healthy functioning while a higher score for a symptom scale represents a higher level of symptomatology or problems.

Movember Foundation

OHSU Knight Cancer Institute

Principal Investigator

Behavioral Symptoms

Participants will receive coach- assisted Beating the Blues (BtB), a C- CBT program, which contains 8 weekly sessions. A coach will provide between session support throughout the 8 sessions.

Participants will receive coach- assisted Entertain Me Well (EMW), an animated C-CBT program, which contains 8 weekly sessions. A coach will provide between session support throughout the 8 sessions.

Participants will use the stand-alone BtB for 8 weekly sessions, without coach assistance.

Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Beating the Blues (BtB)

Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.

Entertain Me Well (EMW)

A coach will spend approximately 5-10 minutes after each session with the patient to link the C-CBT content with patient's disease specific experiences and to motivate them to continue the program. They will also spend approximately 5 minutes between sessions to motivate a patient to complete assignments and to remind them about starting the next session on time.

Anao Zhang, Ph.D.

This project's overall goal is to test the feasibility, acceptability and efficacy of two coach-assisted, computer-based, cognitive- behavioral therapy (C-CBT) interventions in treating depression and anxiety in adolescent and young adult cancer survivors. The two coach-assisted interventions will be compared to the standard C-CBT intervention.

This will be a three-arm randomized controlled trial with two treatment arms and one control arm. Participants in the first treatment arm will receive a coach-assisted C-CBT intervention called "Beating the Blues" (BtB). A second treatment arm will receive a coach-assisted, animated C-CBT intervention called "Entertain Me Well" (EMW). Both treatment arms will have 8 weekly sessions that contain core components of CBT. A coach will provide between-session support throughout the 8 sessions. The control arm will use the standard care of BtB without coach assistance.

This study is a three-arm, prospective randomized controlled trial with participants being randomly assigned into one of the three groups: (1) coach-assisted BtB intervention (treatment condition 1), (2) coach-assisted animated EMW (treatment condition 2), and (3) standard BtB (control group).

Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients

Percentage of participants in each arm who complete at least 6 out of 8 sessions, as measured by online service usage data.

Participants will be interviewed about their perceptions regarding the delivery format, treatment content, and other treatment related factors. Qualitative interviews will be transcribed by research staff and coded using thematic content analysis and axial coding. Qualitative data will be reviewed iteratively until saturation is reached, that is when no new information seems to emerge during coding. Emergence or non-emergence of acceptability theme will be assessed. Findings will be descriptive and will include the percentage of participants who confirm acceptability.

The Patient Health Questionnaire, 9 -item (PHQ-9) is a validated brief measure of depression. Participants will answer the questionnaire at their baseline assessment, at the beginning of each session, and at their post-intervention assessment.

The Generalized Anxiety Disorder, 7-item (GAD-7) is a validated brief measure of anxiety. Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.

The Brief Symptom Inventory, 18-item (BSI-18) is a validated distress screening tool especially for cancer patients. Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.

The PROMIS Self-Efficacy for Managing Chronic Conditions (PROMIS SM Scale) is a 28-item validated tool to assess patients' self-efficacy in managing their chronic condition symptoms.

The Patient Activation Measure (PAM) is a 13-item validated tool to evaluate patients' involvement and participation in their health care. Participants will answer the questionnaire at their baseline assessment and at their post-intervention assessment.

St. Baldrick's Foundation

University of Michigan Rogel Cancer Center

Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.

Subjects is with cancer and receive care from caregivers.

The web application allows caregivers to visually identify and organize their existing social network (family, friends, community of worship, and others) to assist with their support needs, tailored to their context. For each of the six support social support domains (in-home, informational, communication, financial, emotional and spiritual, transportation (e.g., emotional, informational, practical), the enCompass web application prompts the individual to identify members of their network. After completing each domain, caregivers are presented with a visual social support

Eco-mapping tool

Caregivers engage in up to 8 manualized, telephone/videoconference visits with a trained caregiver coach. The caregiver coach uses the study manual and interview guide to provide support for caregiver support-seeking and problem-solving.

Caregiver-coach study visits

Jesse Kovacs

Erin E Kent, PhD, MS

This study explores the feasibility, acceptability, and preliminary efficacy of a social support intervention in cancer caregivers who live in rural communities. Cancer caregivers need support, especially when they live at a distance from healthcare centers. enCompass Carolina is a social support intervention, that supports caregivers by helping them find and use new sources of support. The purpose of this study is to test and receive feedback about the program.

enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers

Study feasibility will be measured by caregiver enrollment rates, defined as the proportion of eligible caregivers approached about the study who consent to participate.

Study feasibility will be measured by caregiver intervention engagement, defined as the proportion of enrolled caregiver subjects who receive at least one intervention visit.

Intervention acceptability will be measured using the Acceptability of the Intervention Measure (AIM) survey scores.

AIM is a survey questionnaire that includes 4 questions. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse-coded.

Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.

Caregiver self-efficacy will be measured using the Coping Self-Efficacy Scale (CSES).

The CSES is a 26-item measure of one's confidence in performing coping behaviour when facing life challenges. It measures the use of problem-focused coping, receiving of social support and stopping unpleasant emotions and thoughts. Scores range from not at all confident=0 to very confident=100. A score of 0 means 'extremely low self efficacy' and a score of 100 means 'extremely high self efficacy'.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer	NCT06057766	Non Small Cell ... Non-small Cell ...	Physical activi...	18 Years -	University Hospital, Ghent
Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design	NCT04583891	Depression, Anx... Engagement, Pat...	IntelliCare Psychoeducation Coaching	18 Years -	University of Virginia
Internet-Based Exercise and Diet Support in Prostate Cancer Survivors	NCT03406013	Cancer Survivor Prostate Carcin...	Written Informa... Prescription Technology Coaching	18 Years -	OHSU Knight Cancer Institute
Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients	NCT04773197	Depression, Anx... Cancer	Beating the Blu... Entertain Me We... Coaching	15 Years - 25 Years	University of Michigan Rogel Cancer Center
enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers	NCT05828927	Cancer	Eco-mapping too... Caregiver-coach...	18 Years -	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for coaching

Every month we try and update this database with for coaching cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for coaching

Every month we try and update this database with for coaching cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for coaching cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.