Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response
- Conditions
- Fatigue
- Interventions
- Behavioral: Mindfulness-Based Stress ReductionBehavioral: Attention Control
- Registration Number
- NCT01919853
- Lead Sponsor
- Indiana University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction 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. Attention Control Attention Control 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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.
Trial Locations
- Locations (4)
Indiana University
🇺🇸Indianapolis, Indiana, United States
Community Health Network--Community North and Carmel Pavilion
🇺🇸Carmel, Indiana, United States
Invoke Yoga Studio
🇺🇸Indianapolis, Indiana, United States
Ransburg YMCA
🇺🇸Indianapolis, Indiana, United States