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| ID | Type | Description | Link |
|---|---|---|---|
| 0106.01 | Other Grant/Funding Number | Walther Cancer Foundation, Inc. |
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| Name | Class |
|---|---|
| Walther Cancer Institute | OTHER |
| Indiana Clinical and Translational Sciences Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | The MBSR intervention is an 8-week course meeting 2 hours weekly. The curriculum is based on MBSR manuals with a brief CRF education component incorporated into the first and second class sessions, drawing from information from the National Comprehensive Cancer Network clinical practice guidelines for CRF. In general, the MBSR class includes guided meditation practice; mindful, gentle movement (hatha yoga); didactic material on self-regulatory responses to stress; and group discussion that includes the participants' growing incorporation of mindfulness in adapting to life experiences. Along with class time, each participant is asked to commit 20 minutes per day, six days per week to formal meditation practice using compact disk recordings of the teacher's voice. |
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| Attention Control | Active Comparator | The attention control is an 8-week class meeting 2 hours weekly. The group sessions are supportive in tone, focus on pre-designated topics relevant to fatigue management (e.g., sleep hygiene, nutrition, exercise, emotional regulation), and involve weekly readings and open group discussion about session topics. This condition contains "non-specific" factors similar to MBSR (e.g., facilitator offering participants compassionate attention, empathy, genuine caring, and an opportunity to discuss what is important to them in a supportive environment); however, mindfulness is not presented/practiced in the group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in cancer-related fatigue functional interference | 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. | from baseline to 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cancer-related fatigue severity | 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. | from baseline to 6 month follow-up |
| Change in vitality |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mindfulness | 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. | from baseline to 6 month follow-up |
| Change in self-compassion |
Inclusion Criteria for breast cancer participants:
Inclusion Criteria for colorectal cancer participants:
Exclusion Criteria for breast cancer participants:
Exclusion Criteria for colorectal cancer participants:
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
Exclusion criteria for non-fatigued BCS participants
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| Name | Affiliation | Role |
|---|---|---|
| Shelley Johns, PsyD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Network--Community North and Carmel Pavilion | Carmel | Indiana | 46032 | United States | ||
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009369 | Neoplasms |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| D004522 | Educational Status |
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Attention Control |
| Behavioral |
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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. |
| from baseline to 6 month follow-up |
| Change in depression | 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. | from baseline to 6 month follow-up |
| Change in anxiety | 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. | from baseline to 6 month follow-up |
| Change in sleep disturbance | 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. | from baseline to 6 month follow-up |
| Change in pain | 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. | from baseline to 6 month follow-up |
| Change in fear of recurrence | The Concerns About Recurrence Scale will be used to assess overall frequency, potential for upset, consistency, and intensity of recurrence fears. | from baseline to 6 month follow-up |
| Change in attentional function | The Attentional Function Index will be used to assess perceived effectiveness in common activities requiring attention and working memory. | 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). |
| from baseline to 6 month follow-up |
| Indiana University |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Invoke Yoga Studio | Indianapolis | Indiana | 46202 | United States |
| Ransburg YMCA | Indianapolis | Indiana | 46219 | United States |
| D004191 |
| Behavioral Disciplines and Activities |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |