Prostate CancerHERONCT03345563
Project HERO: Health Empowerment & Recovery Outcomes
A study testing Body Mind Training (BMT) and Body Training (BT): in people with Prostate Cancer and Bladder Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prostate Cancer, Bladder Cancer, Kidney Cancer
- What is being tested?
- Body Mind Training (BMT) and Body Training (BT):
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2017to 7 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Rectum Cancer, Thyroid Cancer
- Being tested
- Body Mind Training (BMT), Body Training (BT):, Usual Care (UC)
- Keywords
- 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
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Thyroid Neoplasms, Lung Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Mind Training (BMT)Behavioural
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.
Body Training (BT):Behavioural
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.
Usual Care (UC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body Mind Training (BMT) | Experimental | Body mind training Receives: Behavioral: Body Mind Training (BMT) |
| Body Training (BT) | Active comparator | Body training only Receives: Behavioral: Body Training (BT): |
| Usual care (UC): | Other | Control Receives: Behavioral: Usual Care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
13-item self-report scale assessing fatigue and its impact on daily activities during the past 7 days; higher scores indicate less fatigue (range 0-52).
Measured: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
13-item self-report scale assessing fatigue and its impact on daily activities during the past 7 days; higher scores indicate less fatigue (range 0-52). Mean difference between Baseline and timepoint.
Measured: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start31 Jul 2017
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After obtaining informed consent and baseline assessments, cancer survivors aged 55 years and older with some level of fatigue 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 blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of New Mexico
- Responsible party
- Principal investigator, Anita Y. Kinney, PhD, RN, Rutgers, The State University of New Jersey
- Investigators
- Anita Y Kinney, PhD, RN, Principal investigator, Rutgers, The State University of New JerseyMichael R. Irwin, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345563
- Sponsor's protocol ID
- 131816
- Other IDs
- Pro2018002020
- Acronym
- HERO
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2017
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tundealao S, Irwin MR, Cole S, Blair CK, Lu SE, Saraiya B, Kim IY, Guest DD, Lin Y, An J, Arana-Chicas E, Chen C, Handorf E, Stroup A, Kang Y, Arap W, Kinney AY. Biological correlates of cancer-related fatigue in older male cancer survivors. Transl Psychiatry. 2026 Jul 17. doi: 10.1038/s41398-026-04274-1. Online ahead of print.
PubMed 42469198Kinney AY, An J, Lin Y, Tundealao S, Saraiya B, Lu SE, Guest DD, Harding EM, Amorim F, Heidt E, Arana-Chicas E, Chen C, Boyce T, Kim IY, Arap W, Blair CK, Irwin MR. Project HERO: a randomized trial of Tai Chi qigong versus intensity-matched exercise and usual care for fatigue in older male cancer survivors. BMC Complement Med Ther. 2025 Jul 4;25(1):239. doi: 10.1186/s12906-025-04988-7.
PubMed 40616105
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Effects of Tai Chi Qigong (TCQ) for Male Cancer Survivors With Fatigue (HERO)
- ClinicalTrials.gov ID
- NCT03345563
- Acronym / sponsor ID
- HERO / 131816
- Conditions
- Prostate Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Rectum Cancer, Thyroid Cancer
- Keywords
- Prostate Cancer, Fatigue, Elderly, Supportive Care, Light Exercise, Quality of Life, Bladder Cancer, Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of New Mexico
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 7 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- After obtaining informed consent and baseline assessments, cancer survivors aged 55 years and older with some level of fatigue 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.
| Arm | Type | Receives |
|---|---|---|
| Body Mind Training (BMT) | Experimental | Behavioral: Body Mind Training (BMT)Body mind training |
| Body Training (BT) | Active comparator | Behavioral: Body Training (BT):Body training only |
| Usual care (UC): | Other | Behavioral: Usual Care (UC)Control |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Body Mind Training (BMT) |
| 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. | Behavioural | Body Training (BT) |
| 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. | Behavioural | Usual care (UC): |
Primary outcome
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
Time frame: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention
13-item self-report scale assessing fatigue and its impact on daily activities during the past 7 days; higher scores indicate less fatigue (range 0-52).
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale
Time frame: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention
13-item self-report scale assessing fatigue and its impact on daily activities during the past 7 days; higher scores indicate less fatigue (range 0-52). Mean difference between Baseline and timepoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42469198Tundealao S, Irwin MR, Cole S, Blair CK, Lu SE, Saraiya B, Kim IY, Guest DD, Lin Y, An J, Arana-Chicas E, Chen C, Handorf E, Stroup A, Kang Y, Arap W, Kinney AY. Biological correlates of cancer-related fatigue in older male cancer survivors. Transl Psychiatry. 2026 Jul 17. doi: 10.1038/s41398-026-04274-1. Online ahead of print.
- Derived from this study: PubMed 40616105Kinney AY, An J, Lin Y, Tundealao S, Saraiya B, Lu SE, Guest DD, Harding EM, Amorim F, Heidt E, Arana-Chicas E, Chen C, Boyce T, Kim IY, Arap W, Blair CK, Irwin MR. Project HERO: a randomized trial of Tai Chi qigong versus intensity-matched exercise and usual care for fatigue in older male cancer survivors. BMC Complement Med Ther. 2025 Jul 4;25(1):239. doi: 10.1186/s12906-025-04988-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Y Kinney, PhD, RN principal investigator
Rutgers, The State University of New Jersey
Michael R. Irwin, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Mind Training (BMT) and Body Training (BT): in people with Prostate Cancer and Bladder Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale (time frame: Baseline, 6 weeks, 1 week post-intervention, 3 months, 12 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345563, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.