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

Primary Purpose

Fatigue

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Attention Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Cancer, Fatigue, Mindfulness, Meditation, Neoplasms, Signs and symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Community Health Network--Community North and Carmel Pavilion
  • Indiana University
  • Invoke Yoga Studio
  • Ransburg YMCA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Change in attentional function
The Attentional Function Index will be used to assess perceived effectiveness in common activities requiring attention and working memory.

Full Information

First Posted
July 30, 2013
Last Updated
December 31, 2014
Sponsor
Indiana University
Collaborators
Walther Cancer Institute, Indiana Clinical and Translational Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01919853
Brief Title
Treatment for Persistently Fatigued Cancer Survivors: A Randomized Controlled Trial With Biomarker Response
Official Title
Treatment for Breast and Colorectal Cancer Survivors With Persistent Cancer-Related Fatigue: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Walther Cancer Institute, Indiana Clinical and Translational Sciences Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Cancer, Fatigue, Mindfulness, Meditation, Neoplasms, Signs and symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Other Intervention Name(s)
Education/support group
Primary Outcome Measure Information:
Title
Change in cancer-related fatigue functional interference
Description
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.
Time Frame
from baseline to 6 month follow-up
Secondary Outcome Measure Information:
Title
Change in cancer-related fatigue severity
Description
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.
Time Frame
from baseline to 6 month follow-up
Title
Change in vitality
Description
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.
Time Frame
from baseline to 6 month follow-up
Title
Change in depression
Description
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.
Time Frame
from baseline to 6 month follow-up
Title
Change in anxiety
Description
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.
Time Frame
from baseline to 6 month follow-up
Title
Change in sleep disturbance
Description
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.
Time Frame
from baseline to 6 month follow-up
Title
Change in pain
Description
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.
Time Frame
from baseline to 6 month follow-up
Title
Change in fear of recurrence
Description
The Concerns About Recurrence Scale will be used to assess overall frequency, potential for upset, consistency, and intensity of recurrence fears.
Time Frame
from baseline to 6 month follow-up
Title
Change in attentional function
Description
The Attentional Function Index will be used to assess perceived effectiveness in common activities requiring attention and working memory.
Time Frame
from baseline to 6 month follow-up
Other Pre-specified Outcome Measures:
Title
Change in mindfulness
Description
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.
Time Frame
from baseline to 6 month follow-up
Title
Change in self-compassion
Description
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).
Time Frame
from baseline to 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley Johns, PsyD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Network--Community North and Carmel Pavilion
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Invoke Yoga Studio
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ransburg YMCA
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States

12. IPD Sharing Statement

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

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