treatment for persistently fatigued cancer survivors: a randomized controlled trial with biomarker response

Conditions: Fatigue

Summary: the purpose of this study is to compare the effects of mindfulness-based stress reduction (mbsr) to an attention control psycho-educational support group in treating cancer-related fatigue (crf) in early-stage (0-iii) post-treatment cancer survivors with clinically-significant crf. the study will collect, store, and later analyze blood and urine samples for several biomarkers that may be linked to persistent crf in cancer survivors.

this is a randomized, attention control clinical trial to compare mbsr to support and education on biobehavioral outcomes in early-stage (0-iii) post-treatment cancer survivors with clinically-significant crf. the study will use quantitative and qualitative methods to evaluate the following: primary aim 1: determine effect size estimates of mbsr compared to attention control in reducing fatigue interference and the severity of several cancer-related symptoms immediately post-intervention and at 6-month follow-up. exploratory aim 1: to identify potential moderators of intervention effects in breast cancer survivors (bcs) and colorectal cancer survivors (crcs), such as demographic, clinical/disease characteristics, personality traits, and baseline mindfulness level. exploratory aim 2: to compare levels of a number of anti- and pro-inflammatory proteins present in blood and urine between mbsr and attention control groups immediately post-intervention and 6-month follow-up, and between fatigued and non-fatigued breast cancer survivors at baseline.

Eligibility criteria:
inclusion criteria for breast cancer participants: * be age 18 or older * live in the indianapolis region * have an established first-time diagnosis of non-metastatic (stages 0-iii) breast cancer treated with chemotherapy and/or radiation therapy * be in good general health (self-report) * have clinically-significant crf (fatigue symptom inventory \[fsi severity composite ≥ 4\]) that has persisted for the previous 8 weeks or longer. inclusion criteria for colorectal cancer participants: * be age 18 or older * live in the indianapolis region * have an established diagnosis of colorectal cancer (any stage) * in treatment currently or previously with chemotherapy and/or radiation therapy * have clinically-significant crf (fatigue symptom inventory \[fsi severity composite ≥ 4) that has persisted for the previous 8 weeks or longer. exclusion criteria for breast cancer participants: * cancer treatment (chemotherapy, biologic response modifiers, radiation therapy, or surgery) in prior 3 months or \> 5 years ago (endocrine therapy for breast cancer is allowed) * enrollment in hospice care * severe depression (phq-8 ≥ 20) * past participation in a mindfulness meditation class and/or having an established/ongoing meditation practice exclusion criteria for colorectal cancer participants: * enrollment in hospice care * severe depression (phq-8 ≥ 20) * past participation in a mindfulness meditation class and/or having an established/ongoing meditation practice a non-fatigued group of post-treatment bcs will also be enrolled in order to compare baseline levels of all biomarkers and all self-reported psychosocial measures between fatigued and non-fatigued bcs. inclusion criteria for non-fatigued bcs participants * being age 18 or older * having an established first-time diagnosis of non-metastatic (stage 0-iii) breast cancer * being in good general health (self-reported) * having fsi severity composite scores of ≤ 2 exclusion criteria for non-fatigued bcs participants * cancer treatment (chemotherapy, biologic response modifiers, radiation therapy, or surgery) in prior 3 months or \> 5 years ago (endocrine therapy for breast cancer is allowed) * enrollment in hospice care * severe depression (phq-8 ≥ 20)

Keywords: cancer fatigue mindfulness meditation neoplasms signs and symptoms