Clinical trial NCT03345563: Project HERO: Health Empowerment & Recovery Outcomes
Official title: Biobehavioral Effects of Tai Chi Qigong (TCQ) for Male Cancer Survivors With Fatigue (HERO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Bladder Cancer
Kidney Cancer
Colon Cancer
Rectum Cancer
Thyroid Cancer
Lung Cancer
Small Intestine Cancer
Soft Tissue Cancer
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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of New Mexico
First posted: 2017-11-17
Enrollment: 113
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility 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 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

Primary outcomes:
measure: Functional Assessment of Chronic Illness (FACIT)-Fatigue Scale
timeFrame: Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
measure: Inflammation Biology Measures: Changes in circulating levels pro- and anti-inflammatory biomarkers will be assessed by measuring NF-κB and AP-1.
timeFrame: Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months
measure: Gene Expression
timeFrame: Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months
measure: Brief Symptom Inventory-18 (BSI-18)
timeFrame: Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
measure: SF-36v2 Health-Related Quality of Life Survey (Mental and Physical)
timeFrame: Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
measure: Consensus Sleep Diary
timeFrame: Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Anita Y Kinney, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Michael R. Irwin, MD
role: PRINCIPAL_INVESTIGATOR
References: