Fatigue
Conditions
Keywords
Cancer, Fatigue, Mindfulness, Meditation, Neoplasms, Signs and symptoms
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness-Based Stress Reduction
BEHAVIORALAttention Control
Sponsors
Walther Cancer Institute
Indiana Clinical and Translational Sciences Institute
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer-related fatigue functional interference | from baseline to 6 month follow-up | The Fatigue Symptom Inventory interference subscale will be used to assess the degree to which CRF was judged to interfere with quality of life across seven domains over the previous week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer-related fatigue severity | from baseline to 6 month follow-up | The Fatigue Symptom Inventory severity subscale will be used to assess the most, least, and average fatigue in the past week, as well as current fatigue. |
| Change in vitality | from baseline to 6 month follow-up | The Short Form (36) Health Survey Vitality Scale will be used to assess how much during the past 4 weeks the person had a lot of energy, felt full of life, felt worn out, and felt tired. |
| Change in depression | from baseline to 6 month follow-up | The PHQ-8 scale will be used to assess how often the person has been bothered over the previous 2 weeks by symptoms of depression, including little interest or pleasure in doing things and feeling down, depressed, or hopeless. |
| Change in anxiety | from baseline to 6 month follow-up | The GAD-7 scale will be used to assess how often the person has been bothered over the previous 2 weeks by symptoms such as: feeling nervous, anxious, or on edge; not being able to stop or control worrying; and trouble relaxing. |
| Change in fear of recurrence | from baseline to 6 month follow-up | The Concerns About Recurrence Scale will be used to assess overall frequency, potential for upset, consistency, and intensity of recurrence fears. |
| Change in attentional function | from baseline to 6 month follow-up | The Attentional Function Index will be used to assess perceived effectiveness in common activities requiring attention and working memory. |
| Change in sleep disturbance | from baseline to 6 month follow-up | The Insomnia Severity Index will be used to assess the perceived severity of insomnia and the impact of sleep difficulties over the previous 2 weeks. |
| Change in pain | from baseline to 6 month follow-up | The Brief Pain Inventory-3 is a brief pain measure derived from the Brief Pain Inventory. It is also known as the PEG and will be used to assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G) over the past week. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in mindfulness | from baseline to 6 month follow-up | The Five Facet Mindfulness Questionnaire will be used to assess the five facets of a general tendency to be mindful in daily life- observing, describing, acting with awareness, non-judgment of inner experience, and non-reactivity to inner experience. |
| Change in self-compassion | from baseline to 6 month follow-up | The Self-Compassion Scale-Short Form will be used to assess attitudes associated with self-compassion. The scale includes 3 positive subscales (self-kindness, common humanity, mindfulness) and 3 negative subscales (self-judgement, isolation, and over-identification). |
Countries
United States
Outcome results
None listed