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)
Anus
Breast
Colon
Rectum
Small Intestine