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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919853
• Other study ID #: 01206008951
• Secondary ID: 0106.01
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2013
• Last updated: December 31, 2014
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction

• Attention Control

Locations

Country	Name	City	State
United States	Community Health Network--Community North and Carmel Pavilion	Carmel	Indiana
United States	Indiana University	Indianapolis	Indiana
United States	Invoke Yoga Studio	Indianapolis	Indiana
United States	Ransburg YMCA	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Change in self-compassion	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	No
Primary	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	No
Secondary	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	No
Secondary	Change in vitality	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No