Project HERO: Health Empowerment & Recovery Outcomes (HERO)

Biobehavioral Effects of Tai Chi Qigong (TCQ) for Male Cancer Survivors With Fatigue (HERO)

Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT, i.e. Tai Chi and Qigong in this project) 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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Small Intestine Cancer; Lung Cancer; Prostate Cancer; Bladder Cancer; Colon Cancer; Thyroid Cancer; Rectum Cancer; Soft Tissue Cancer
• Intervention / Treatment: Behavioral: Body Mind Training (BMT); Behavioral: Body Training (BT):; Behavioral: Usual Care (UC)

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. Post-award, the target sample size was revised to (n=166) with NCI permission.

There are over 9 million cancer survivors who are 55 years of age or older. Cancer survivors in this age group have unique challenges coping with the 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, Tai Chi and Qigong (TCQ) may be more appealing because it is not overly physically exertive and is safe for people 55 years of age or older. In this study, we referred to the intervention groups as follows: TCQ intervention was referred to as body-mind training (BMT), and the exercise intensity-matched condition was referred to as body training (BT). This was done to help reduce bias by minimizing participants' expectations or perceived differences between the groups.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 months
• 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: Medical Health Outcome Study Short Form Vitality/Fatigue subscale (SF-36 Vitality scale-4 items; 5 Likert scale) using a fatigue cut-off value of ≤13; or the Patient-Reported Outcomes Measurement Information System Fatigue scale (PROMIS Fatigue scale) using a cut-off value of ≥9
• 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 a 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Body Mind Training (BMT); Body mind training	Behavioral: Body Mind Training (BMT); 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.
Active Comparator: Body Training (BT); Body training only	Behavioral: Body Training (BT): 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.
Other: Usual care (UC): Control	Behavioral: Usual Care (UC); 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.

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 from baseline to 3-months post intervention: 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
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
Pittsburgh Sleep Quality Index (PSQI)	Questionnaire: Measures sleep disturbance with 19 items, generating seven component scores: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances, Use of sleeping aid medication(s), and Daytime dysfunction. The global PSQI score is a composite of the 7 component scores, ranging from 0 to 21, which was used in this study.	Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: University of California, Los Angeles; University of New Mexico
• Investigators: Principal Investigator: Anita Y Kinney, PhD, RN, Rutgers, The State University of New Jersey; Principal Investigator: Michael R. Irwin, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; Lung Cancer; Quality of Life; Fatigue; Prostate Cancer; Supportive Care; Bladder Cancer; Colon Cancer; Kidney Cancer; Soft Tissue Cancer; Light Exercise; Rectum Cancer; Throid Cancer; Small Intestine Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Colonic Diseases; Urologic Neoplasms; Carcinoma; Neoplasms, Connective and Soft Tissue; Urinary Bladder Diseases; Prostatic Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Carcinoma, Renal Cell; Intestinal Neoplasms; Sarcoma; Urinary Bladder Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: 131816; Pro2018002020 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No