Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Syndrome

Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

The standardized 16-form Yang-style Tai-Chi exercise set will be adopted.

The aerobic exercise class will be designed to cover both aerobic and resistance exercises.

Patients in this group will receive written information regarding the recommended levels of exercise (i.e., at least 150 min of moderate-intensity or 75 min of vigorous-intensity aerobic exercise every week) that they can perform at home (self-management) while continuing to receive their standard treatment. They will also be provided with a daily exercise log to record their exercise type, frequency, and intensity.

The standardized 16-form Yang-style Tai-Chi exercise set will be adopted. Group classes will take place in a community center twice a week for 16 weeks, with each class lasting approximately 60 minutes. Classes will be taught by an experienced Tai-Chi master. Patients will be instructed to practice the Tai-Chi exercises at home at least 3 times a week (30 min each time for a total of 90 min). Patients will be provided with a daily exercise log to record their exercise type, frequency, and intensity.

Tai-Chi intervention

The aerobic exercise class will be designed to cover both aerobic and resistance exercises. Group classes will take place in an exercise center twice a week for 16 weeks, with each class lasting approximately 60 minutes. Each class will be led by a certified exercise specialist. Patients will be provided with a daily exercise log to record their exercise type, frequency, and intensity.

Aerobic exercise intervention

Chia-Chin Lin, PhD,FAAN,RN

Naomi Takemura, BNurs,PhD,RN

The goal of this randomized controlled trial is to investigate the effects of Tai-Chi and aerobic exercise on the emotional symptom cluster, and the underlying mechanism of that cluster, in late-stage lung cancer patients. Participants will be randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity.

Late-stage lung cancer patients (n = 318) meeting the inclusion criteria will be recruited and randomized into one of three groups: 1) Tai-Chi group, 2) aerobic exercise group, or 3) self-management control group. Both the Tai-Chi and aerobic exercise groups will attend twice-weekly group classes for 16 weeks (32 total contact hours). The self-management control group will receive written information regarding the recommended level of physical activity. To evaluate the effectiveness of Tai-Chi and aerobic exercise in alleviating the emotional symptom cluster (primary outcome) and individual symptoms (sleep disturbance, anxiety, depression, fatigue), outcome measures will be conducted at baseline, 8 weeks (mid-point assessment), 16 weeks (post-intervention), and 28 weeks (12-weeks post-intervention). A linear mixed-effects model will be used to study the between-group differences in outcomes. In addition, emotion regulation, mindfulness, and cardiorespiratory fitness will be evaluated at each data collection point, and structural equation modeling will be used for subsequent mediation analysis to determine their mediating role in outcome changes. Qualitative interviews will be conducted to understand patients' experience and evaluation of the interventions.

Except for the primary research assistant who will inform the patients of their group allocation, all researchers on the team will be blinded to patients' group assignment.

Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients

NRSs for assessing each symptom of sleep disturbance, anxiety, depression, and fatigue over the past 7 days will be used to measure emotional symptom cluster severity. Higher score indicates more severe symptoms.

Measured by the Pittsburg Sleep Quality Index. The total score ranges from 0-21, with higher scores denoting poorer sleep.

Measured by the Brief Fatigue Inventory. Higher score denotes worse fatigue level.

Measured by the Hospital Anxiety and Depression Scale. Higher score denotes higher level of anxiety and depression.

Measured by the Emotion Regulation Questionnaire. Higher scores indicating greater usage of that strategy.

Measured by the Five Facet Mindfulness Questionnaire-Short Form. Higher score denotes higher mindfulness experience.

Measured by the six-minute walk test. The distance walked at the end of 6 minutes will be measured in meters.

Measured by the timed up-and-go test; unit: second.

Measured by the sit-to-stand test; unit: number of times.

Measured by the single-leg standing test; ; unit: second.

Queen Mary Hospital, Hong Kong

The University of Hong Kong

Professor and Head

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Obesity

Insulin Resistance

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Reproductive Control Agents

Central Nervous System Depressants

Other Dietary Supplements

Insulin

Insulin, Globin Zinc

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Mitogens

Benzocaine

Estropipate

Estrone

Tannic Acid

Women randomized to the exercise intervention arm completed a one year aerobic exercise intervention of 225 minutes/week.

Women randomized to the control arm were asked to maintain their regular lifestyle which meant no changes to their exercise or dietary intake. Women eligible for this trial were inactive and hence were expected not to increase their levels of physical activity in the control arm.

Women in the exercise arm underwent a year-long exercise intervention of five days per week of 45 minutes/session of moderate-vigorous intensity aerobic exercise.

Christine M Friedenreich, PhD

The purpose of the ALPHA Trial is to examine the physiologic changes that occur in a woman's body when she begins exercising that may be related to a change in her risk of getting breast cancer.

The goal of this study is to examine how a one-year exercise intervention, as compared to a usual sedentary lifestyle, influences specific biologic mechanisms that are hypothesized to be operative in the association between physical activity and breast cancer risk. These biologic mechanisms include sex hormone concentrations (estrone, estradiol and sex-hormone binding globulin); measures of adiposity and obesity; mammographic density; insulin-like growth factors; and insulin resistance.

A two-centered, two-armed randomized controlled trial (RCT) of exercise and risk factors for breast cancer will be conducted. Approximately 334 postmenopausal, sedentary women will be recruited to the study. Participants will be randomized to one of two groups: an exercise intervention, or a control group. The intervention group will undertake five weekly exercise sessions of 60 minutes each; three will be facility-based and two will be home-based each week. The Edmonton and Calgary exercise oncology facilities will be working in collaboration, and each will include both the controls and exercise intervention arms of the trial. The exercise intervention will last for 12 months. The control group will be asked not to change their usual level of activity during that time.

Baseline assessments will be obtained of serum sex hormones (estrone and estradiol), measures of obesity and adiposity, mammographic density, serum insulin growth factor (IGF)-1, insulin resistance, aerobic capacity, and psychosocial health measures. At the end of the study, all baseline assessments will be repeated and compared between the two groups.

This study will specifically address identified gaps in knowledge, in terms of examining the simultaneous effect of physical activity on several biologic mechanisms in a controlled trial setting, building on evidence from the only other randomized controlled trial on this topic. Strengths of the proposal include the multi-centered setting (utilizing facilities in both Calgary and Edmonton), and the collaboration of an experienced multi-disciplinary research team from across North America.

Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

The effect of the exercise intervention on sex steroid and adiposity levels after one year is examined.

The effect of the exercise intervention after one year is examined.

Canadian Breast Cancer Research Alliance

University of Alberta

University of Calgary

AHS Cancer Control Alberta

Scientific Leader and Principal Investigator

Fatigue

Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.

Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.

After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.

Participate in aerobic exercise intervention

Aerobic Exercise Intervention

Participate in resistance exercise intervention

Resistance Exercise Intervention

Receive digital copy of AE and RE sessions and an outline of sessions

Exercise Intervention: Digital copies and outline of sessions

Questionnaire Administration

Quality-of-Life Assessment

Kerryn W Reding, PhD, MPH, RN

This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.

OUTLINE: Patients are randomized to the interventional groups or control group.

INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms.

ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and resistance exercise (RE) sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.

ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.

CONTROL GROUP: After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.

Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial

Investigating Various Adaptive-Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment (ACTIVATE)

This is operationalized as maximal exercise capacity, which is ascertained by measuring peak oxygen consumption (volume oxygen \[VO2\] peak) during cardiopulmonary exercise testing (CPET). All CPETs will be administered by a trained exercise physiologist using the Modified Bruce protocol, an appropriate testing paradigm for people with reduced physical functioning. This procedure will estimate the VO2 (absolute).

This is operationalized as maximal exercise capacity, which is ascertained by measuring peak oxygen consumption (volume oxygen \[VO2\] peak) during cardiopulmonary exercise testing (CPET). All CPETs will be administered by a trained exercise physiologist using the Modified Bruce protocol, an appropriate testing paradigm for people with reduced physical functioning. This procedure will estimate the VO2 (relative to bodyweight).

Submaximal exercise capacity, also considered functional capacity, will be determined with the six minute walk test (6MWT), which measures the distance a person can walk in six minutes (6MWD). A widely used measure of submaximal exercise capacity, the 6MWT will be administered at all study timepoints to evaluate intervention response.

Prior to the measurement of body weight, participants will be instructed to remove heavy clothing and empty pockets of their contents. Weight will be measured to the nearest one-tenth kg with a calibrated balance beam or digital scale.

Hip circumference will be measured to the nearest one-tenth cm.

Height will be measured while the participant stands without shoes using a wall-mounted stadiometer to the nearest one-tenth cm.

Subcutaneous (SQ) fat and visceral adipose tissue (VAT) will be assessed via abdominal MRI. For analysis, fat depots will be separated into abdominal SQ fat and VAT which will be further segmented into intraperitoneal (IP) and retroperitoneal (RP) fat using commercially available software. SQ fat will be defined as the fat outside the muscular abdominal wall; IP fat as fat within the mesentery and omentum bounded anteriorly and laterally by the abdominal wall and posteriorly by a curved line drawn between the kidneys; RP fat as the remaining fat. Adipose tissues will be segmented and colored from other tissues based on pixel intensity and known divisions of tissue planes. The MRI analyst, blinded to participant characteristics, will correct any misidentified fat or non-fat regions using manual tools provided within the software. To calculate each of the compartmental fat deposits, the number of subpixels within each fat compartment.

The ratio of thigh IMF to skeletal muscle (SM) will be ascertained via magnetic resonance imaging (MRI) by trained MRI technologists. Participants will undergo a screening process with the MRI technologist to ensure that eligibility criteria for MRI scans are met. Participants will then change into a hospital gown and enter the MRI scanner. In this longitudinal assessment of IMF, the MRI technologist will be instructed to match participant scan positions across time by matching the current scan position with the participant's previous scan position, recorded at the timepoint prior. MRI analysts will quantitate total and compartment amounts of muscle and adipose tissue using cross-sectional areas of thigh skeletal muscle (SM) and IMF using commercially available software. Thigh IMF area will be calculated as the number of fat pixels within the thigh musculature multiplied by the pixel surface area.

Waist circumference will be measured to the nearest one-tenth cm.

The Short Form Health Survey-36 (SF-36) is a widely used self-report measure of quality of life and health status. Comprised of 36 multiple choice questions, the SF-36 queries general perceptions a participant has about their health, as well as limitations to physical activity, physical health problems, mental health problems, pain, and energy/fatigue. The SF-36 is used across health research domains, and in breast cancer has been validated as a reliable longitudinal monitor of quality of life.

Time spent engaging in physical activity will be measured with the Physical Activity Recall Interview. The PAR assesses time spent in physical activity over the past 7 days.

Participants' perception of their current well-being will be assessed with the 28-item 5-point Likert scale Functional Assessment of Cancer Therapy (FACT)-General. The FACT-G contains 4 subscales measuring physical, social, emotional, and functional well-being and has been validated for reliably measuring well-being in cancer patients.

Time spent engaging in sedentary lifestyle behaviors will be measured with the self-administered Sedentary Behaviors Questionnaire (SBQ). The SBQ measures the minutes spent participating in 9 different sedentary behaviors per "typical" weekday and weekend day.

The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale is a 13-item scale originally developed for and widely used to assess cancer-related fatigue. The FACIT-Fatigue scale measures severity (i.e., "I feel fatigued"; "I feel weak all over") and impact of fatigue (e.g., "I need help doing my usual activities"; "I have to limit my social activity because I am tired") over the past week, with responses scored on a 5-point scale, from 0 "not at all" to 4 "very much." The FACIT-Fatigue scale has excellent psychometric properties and a focus on physical aspects of fatigue.

Will be determined with all-cause intervention discontinuation rate, which is the proportion of all intervention participants who permanently stop the intervention prior to week 24 for any reason.

Intervention safety will be determined by reviewing and quantifying the number of adverse events (mild, moderate, or severe), serious adverse events, and by reviewing the type and severity of adverse events attributed to study procedures among each study group.

Study feasibility will be measured by calculating recruitment rates (proportion of enrolled participants to all individuals approached), and loss to follow-up (proportion of participants who do not complete post-intervention assessments). A benchmark to determine feasibility is \< 40% loss to follow-up.

Acceptability will be measured with qualitative, open-ended to assess participant experience in the intervention and gather information for improving the protocol in future studies. Of particular attention will be the tolerability of a remote, home-based exercise intervention with a semi supervised format.

The Rating of Perceived Exertion (RPE) scale asks respondents to rate the intensity of exercise on a 1-10 scale, with higher values representing greater perceived exertion (1 = Very Light Activity, 10 = Maximum Possible Exertion). The measure has been validated for estimating both aerobic and resistance exercise exertion levels, providing a standard measure across intervention modalities. The average RPE for full-intensity sessions (the first few weeks involve an increasing RPE across sessions) will be calculated for each participant.

Participants will complete an RPE rating after each session. These ratings will be used to calculate adherence rate for each participant. A session with an RPE that is at or above the intended RPE will be considered adherent. The number of adherent sessions will be divided by the total number of sessions, whether the session was attended or not. The participant adherence rates will be averaged to find a mean adherence rate per participant.

National Cancer Institute (NCI)

University of Washington

Associate Professor

Every two weeks, all participants were emailed a self-report survey to indicate the presence, severity, interference, and attribution of various medical symptoms

ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and resistance exercise (RE) sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.

Arm I: Aerobic Exercise

ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.

Arm II: Resistance Exercise

After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.

Exercise Intervention: Digital copies and outline of sessions: Receive digital copy of AE and RE sessions and an outline of sessions

Questionnaire Administration: Ancillary studies

Quality-of-Life Assessment: Ancillary studies

Control Group

Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.

Aerobic Exercise Intervention: Participate in aerobic exercise intervention

Resistance Exercise Intervention: Participate in resistance exercise intervention

Quality-of-Life Assessment: Ancillary studies

Arm I (Aerobic Exercise)

Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.

Aerobic Exercise Intervention: Participate in aerobic exercise intervention

Resistance Exercise Intervention: Participate in resistance exercise intervention

Questionnaire Administration: Ancillary studies

Quality-of-Life Assessment: Ancillary studies

Arm II (Resistance Exercise)

Control Group (Digital Exercise Interventions)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Kerryn Reding, Study Principal Investigator

Intervention Feasibility

Count of participants with at least one AE

Gastrointestinal/Digestive

Respiratory

Skin

Musculoskeletal

Nervous System/Neurological

Psychiatric

Injuries

Arm 1: Aerobic Exercise

Only adverse events probably or definitely attributed to study procedures are counted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer Patients	NCT05778708	Advanced Lung N...	Tai-Chi interve... Aerobic exercis...	18 Years -	The University of Hong Kong
Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial	NCT00522262	Breast Neoplasm...	Aerobic exercis...	50 Years - 74 Years	AHS Cancer Control Alberta
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial	NCT04667481	Breast Cancer Invasive Breast...	Aerobic Exercis... Resistance Exer... Exercise Interv... Questionnaire A... Quality-of-Life...	18 Years - 75 Years	University of Washington
Exercise Effect on Chemotherapy-Induced Neuropathic Pain	NCT02991677	Cancer, Breast Cancer, Colorec... Cancer, Lung Cancer, Ovarian	aerobic exercis... control group resistive train...	21 Years - 70 Years	Baltimore VA Medical Center
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial	NCT04667481	Breast Cancer Invasive Breast...	Aerobic Exercis... Resistance Exer... Exercise Interv... Questionnaire A... Quality-of-Life...	18 Years - 75 Years	University of Washington
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial	NCT04667481	Breast Cancer Invasive Breast...	Aerobic Exercis... Resistance Exer... Exercise Interv... Questionnaire A... Quality-of-Life...	18 Years - 75 Years	University of Washington

Spots Global Cancer Trial Database for aerobic exercise intervention