Programs to Support You During Chemotherapy (Pro-You)

Fatigue Clinical Trial

— Pro-You  

Official title:

Programs to Support You During Chemotherapy (Pro-You): Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148406
• Other study ID #: VICC GI 1416
• Secondary ID: NCI-2014-00905VI
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: June 19, 2015
• Start date: August 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.

Description:

PRIMARY OBJECTIVES:

I. To obtain preliminary data on the efficacy of the Yoga Skills Training (YST) for improving the targeted outcomes (primary: fatigue; secondary: depressive symptoms) as compared to the attention control (AC).

II. To explore potential mediators (psychological stress, circadian disruption, inflammation) and moderators (gender, dose of the YST, outcome expectancies) of the effects of the YST on targeted outcomes.

III. To qualitatively assess perceived efficacy of the interventions and acceptance of daily measurement through semi-structured interviews in a subset of participants.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (YST intervention): Patients undergo YST intervention comprising four individualized, 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation during outpatient chemotherapy sessions in weeks 2, 4, 6, and 8. Patients practice awareness - noticing the current state and establishing relaxed breathing for 5 minutes; movement - 7 minutes of gentle movements coordinated with the breath (such as raising and lowering the arms); breathing practice - 3 minutes of inhaling cool air as if through a straw; and meditation - 5 minutes of focus on letting go of physical and mental tension. Patients are given a handout describing the YST and audio recording with devices to play the recording to encourage patients to practice daily. Strategies to increase adherence to home practice will be implemented and patients will be asked to keep home practice logs.

ARM II (attention control): Patients attend four 30-minute in-person sessions with an interventionist in weeks 2, 4, 6, and 8. During these sessions, patients are encouraged to discuss their experiences while receiving chemotherapy and do not receive instruction of movement, meditation or breathing practices. Patients will also be asked to write brief diary entries daily at home.

After completion of study, patients are followed up for 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled to receive first-line intravenous chemotherapy treatment for colorectal cancer (stages II-IV)

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1

• Ability to understand and the willingness to sign an informed consent document written in English

Exclusion Criteria:

• Regularly engaged (>= 3 days/week) in moderate physical activity of any kind (e.g., yoga) over the past 4 weeks

• Has a self-reported history of diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia), comorbidities associated with poor sleep or fatigue (e.g., chronic fatigue syndrome), or a job with night shifts

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depressive Symptoms
• Fatigue
• Psychosocial Effects of Cancer and Its Treatment
• Rectal Neoplasms
• Stage IIA Colon Cancer
• Stage IIA Rectal Cancer
• Stage IIB Colon Cancer
• Stage IIB Rectal Cancer
• Stage IIC Colon Cancer
• Stage IIC Rectal Cancer
• Stage IIIA Colon Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Colon Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Colon Cancer
• Stage IIIC Rectal Cancer
• Stage IVA Colon Cancer
• Stage IVA Rectal Cancer
• Stage IVB Colon Cancer
• Stage IVB Rectal Cancer

Intervention

Behavioral:
• Yoga Skills Training (YST)
Undergo YST

Other:
• questionnaire administration
Ancillary studies
• fatigue and depressive symptom assessment and management
Ancillary studies
• psychological stress assessment
Ancillary studies
• laboratory biomarker analysis
Correlative studies
• Attention Control

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rates of home practice as assessed by daily paper logs	Mean levels of rates (%s) will be assessed	Up to 10 weeks	No
Other	Rates of survey compliance	Mean levels of rates (%s) will be assessed	Up to 10 weeks	No
Other	Rates of efficacy expectations as assessed by adapted items the Life Orientation Test-Revised	Mean levels of rates (%s) will be assessed	Up to 10 weeks	No
Other	Rates of satisfaction	Mean levels of rates (%s) will be assessed.	Up to 14 weeks	No
Other	Reliability of the responses		Up to 14 weeks	No
Other	Changes in circadian disruption (daily and recalled) as assessed by actigraphy and the Godin's Leisure Score Index	Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation	Baseline up to 14 weeks	No
Primary	Changes in fatigue (recalled)	Patient-Reported Outcomes Measurement Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.	at 10 weeks	No
Secondary	Changes in depressive symptoms (recalled and daily)	Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.	Baseline up to 14 weeks	No
Secondary	Changes in daily fatigue	Patient-Reported Outcomes Measurement Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.	Baseline up to 14 weeks	No
Secondary	Changes in psychological stress (daily and recalled) as assessed by Perceived Stress Scale (PSS)	Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.	Baseline up to 14 weeks	No
Secondary	Regulation of psychological stress (daily and recalled) as assessed by Positive and Negative Affect Schedule-Expanded Form and Cancer Behavior Inventory	Graphical and descriptive summaries of the patterns over time of these summary statistics for each of these groups will comprise a key initial phase of the analyses. Bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive statistics and effect estimates. Key statistical tests will involve between group differences in mean values and group differences in the patterns (i.e., slopes) of individual changes from respective baseline values. Evaluated using mixed-effects (or multilevel) generalized linear modeling procedures with robust variance estimation.	Up to 14 weeks	No

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial