Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response

Treatment for Breast and Colorectal Cancer Survivors With Persistent Cancer-Related Fatigue: A Randomized Controlled Trial

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.

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)