Clinical trial NCT01919853: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatigue
Keywords: Cancer
Fatigue
Mindfulness
Meditation
Neoplasms
Signs and symptoms
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Walther Cancer Institute
name: Indiana Clinical and Translational Sciences Institute
First posted: 2013-08-09
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in cancer-related fatigue functional interference
timeFrame: from baseline to 6 month follow-up
Secondary outcomes:
measure: Change in cancer-related fatigue severity
timeFrame: from baseline to 6 month follow-up
measure: Change in vitality
timeFrame: from baseline to 6 month follow-up
measure: Change in depression
timeFrame: from baseline to 6 month follow-up
measure: Change in anxiety
timeFrame: from baseline to 6 month follow-up
measure: Change in sleep disturbance
timeFrame: from baseline to 6 month follow-up
measure: Change in pain
timeFrame: from baseline to 6 month follow-up
measure: Change in fear of recurrence
timeFrame: from baseline to 6 month follow-up
measure: Change in attentional function
timeFrame: from baseline to 6 month follow-up
Other outcomes:
measure: Change in mindfulness
timeFrame: from baseline to 6 month follow-up
measure: Change in self-compassion
timeFrame: from baseline to 6 month follow-up
Locations:
city: Carmel
country: United States
facility: Community Health Network--Community North and Carmel Pavilion
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Invoke Yoga Studio
state: Indiana
city: Indianapolis
country: United States
facility: Ransburg YMCA
state: Indiana
Study officials:
affiliation: Indiana University
name: Shelley Johns, PsyD
role: PRINCIPAL_INVESTIGATOR
References: