Project HERO: Health Empowerment & Recovery Outcomes

Study Overview
=================
Brief Summary
-----------------
Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT) for reducing fatigue in male cancer survivors. This 3-arm randomized clinical trial will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention's effect.

Detailed Description
-----------------
This study will establish the efficacy of a 12-week Body Mind Training (BMT) for reductions in fatigue (the study's primary outcome). Secondary patient-reported outcomes include quality of life changes (e.g. changes in sleep and perceived psychological distress), changes in the biomarkers of inflammation; including genome wide transcriptional factors, and expression of fatigue-related genes. There are over 9 million cancer survivors that are 55 years of age or older. Cancer survivors in this age group have unique challenges coping with late and long-term effects of having had a cancer diagnosis and treatment, coupled with age-related declines and comorbidities. This may influence their ability to engage in lifestyle interventions because of slower post-treatment recovery, increased functional limitations, and other quality of life (QOL) impairments. Fatigue is common, under-recognized, undertreated and correlated with impairments in psychological distress, social and functional well-being and health-related QOL in cancer survivors. For male cancer survivors suffering from fatigue, body-mind training (BMT) may be more appealing because it is not overly physically exertive and is safe for people 55 years of age or older.

Official Title
-----------------
Biobehavioral Effects of Body Mind Training (BMT) for Male Cancer Cancer Survivors With Fatigue (HERO)

Conditions
-----------------
Prostate Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Rectum Cancer, Thyroid Cancer, Lung Cancer, Small Intestine Cancer, Soft Tissue Cancer

Intervention / Treatment
-----------------
* Behavioral: Body Mind Training (BMT)
* Behavioral: Body Training (BT):
* Behavioral: Usual Care (UC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria: Inclusion Criteria: Age ≥ 55 years Previous diagnosis of local, regional, or metastatic cancer. If treated for cancer, prostate cancer therapy completed, 3+ months If on ADT/ hormone manipulation, must be for 4 or more month Previous diagnosis of small intestine, thyroid, oral, non-muscle invasive bladder, kidney/renal, lung, colon, rectum, soft tissue, or other cancer Meet study criteria for fatigue (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAEv4.0)) using a fatigue cut-off value of ≥1 or a general fatigue grading scale (i.e., fatigue currently and in the past week from a scale of 0-100) with a cut-off value of >20 Live within 75 miles of New Brunswick or Newark Inactive (<150 minutes of vigorous exercise/week within the past 3 months) Has transportation to attend on-site classes and assessments Exclusion Criteria: Patient Health Questionnaire PHQ-9 Score >12 Indication of suicidality from PHQ-9, reports that he has several or more days of thoughts that you would be better off dead, or of hurting yourself Karnofsky performance status score of 50 or below Current regular practice within the past year (2-3 times a week over a period of two months that is not interrupted) of BMT or other complementary and alternative medicine that shares similar principles of BMT. Inability to speak and read English proficiently Unable to understand informed consent Current health conditions that may interfere with the intervention: respiratory, cardiovascular, or neurological problems unless released by physician Medical conditions or activities that can cause severe fatigue: Severe hearing loss that would cause difficulty following an instructor in a group setting, chronic fatigue syndrome, current major depression, alcohol use disorder, shift work Prostate cancer that has metastasized to the liver, brain, or lungs Currently receiving chemotherapy with VePesid, Cytoxan, Enzalutamide (XTANDI®), intravenous chemotherapy or radionucleotides (Strontium-89, Samarium (Quadramet®), Radium-223 (Xofigo®)), or other therapy (as confirmed by study team) Unwilling to be randomized to study arms and/or commit to 12 weeks of classes and assessments Have had a diagnosis of another cancer, unless: Non-melanoma skin cancer, or Completed treatment AND cancer-free for 5 or more years. We will not include any of the following special populations: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After obtaining informed consent and baseline assessments, 210 fatigued cancer survivors age 55 years and older will be randomized to the BMT arm or intensity-matched Body Training (BT), or Usual Care (UC) arms. Patient-reported assessments (surveys) will occur at baseline (within 2-weeks pre- intervention), mid-intervention (6 weeks), 1-week post-intervention (13 weeks), and at 3 months and 12 months post-intervention. Phlebotomy is done at baseline, 1 week post intervention (13 weeks), and 3 months and 12 months post intervention. Dietary assessments are done at baseline, and week 13 (1 week post intervention), 3 months and 1 year post-intervention. Physical activity is assessed weekly throughout the intervention. Sleep diaries are collected at all time points.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body Mind Training (BMT)<br>Body mind training | Behavioral: Body Mind Training (BMT)<br>* Participants will practice BMT under the instruction of a BMT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Each session will include both light physical exercise and mind training. Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.<br>|
| Active Comparator: Body Training (BT)<br>Body training only | Behavioral: Body Training (BT):<br>* Participants will practice BT under the instruction of a BT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.<br>|
| Other: Usual care (UC):<br>Control | Behavioral: Usual Care (UC)<br>* Participants in the usual care arm will receive care as normal and will not attend classes but will complete the same assessments as participants in the BMT and BT classes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Chronic Illness (FACIT)-Fatigue Scale | Change in fatigue levels over time: measured with 13-item scale assessing the level of fatigue during usual activities over the 7 days prior to the measurement timepoint, with higher scores indicating less fatigue. Administered at several time points to measure the effect the intervention. | Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berlin Sleep Questionnaire | Questionnaire: consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. | Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months | 
| Inflammation Biology Measures: Changes in circulating levels pro- and anti-inflammatory biomarkers will be assessed by measuring NF-κB and AP-1. | Blood samples will be collected at using standardized procedures. The dynamics of inflammation will be measured by using a vertically integrated mechanistic approach and examining upstream signaling pathways and circulating levels. Circulating levels will be assessed by assay of plasma pro- and anti-inflammatory biomarkers; Inflammatory signaling as indexed by activation of key inflammatory transcription factors (e.g., NF-κB) will be measured using intranuclear staining and flow cytometric analyses. Genome-wide transcriptional analyses (all baseline and 13-week biospecimens) will be used to identify the differential regulation of gene expression and the molecular inflammation-related signaling pathways that are plausible candidates driving these changes (e.g., NF-κB). | Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months | 
| Gene Expression | Specimen collection and analysis to measure mRNA intercorrelations: 1) Inflammation, Vasodilation, and Metabolite Sensing and 2) Energy and Adrenergic Activation. | Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months | 
| Brief Symptom Inventory-18 (BSI-18) | Questionnaire: Psychological distress (depression and anxiety) is measured using the using the Brief Symptom Inventory-18 instrument. Items are summed to calculate the raw score, range 0-72. Raw scores can be converted to T-scores, based on US population norms. Participants with T-scores that are ≥ 63 are considered a case, and may need professional help. Somatization Scale: Raw score range 0-24, with 24 indicating high somatization. Depression Scale: Raw score range 0-24, with 24 indicating high depression. Anxiety Scale: Raw score range 0-24, with 24 indicating high anxiety. | Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months | 
| SF-36v2 Health-Related Quality of Life Survey (Mental and Physical) | Questionnaire: Provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. The raw score of each of the eight SF-36 dimensions was derived by summing the item scores. Subtract the lowest possible raw score from the actual raw score, divide by the possibly raw score range, and multiply by 100 to get the transformed scale. Higher scores indicate better health-related quality of life. | Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months | 
| Consensus Sleep Diary | The sleep diary is designed to gather information about daily sleep patterns. Sleep diary is maintained for 7 days prior to each data collection time point. | Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Fatigue, Elderly, Supportive Care, Light Exercise, Quality of Life, Bladder Cancer, Kidney Cancer, Colon Cancer, Rectum Cancer, Throid Cancer, Lung Cancer, Small Intestine Cancer, Soft Tissue Cancer