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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
113
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.
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.
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.
Rutgers University
New Brunswick, New Jersey, United States
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.