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Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Physical Activity
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasms

Eligibility Criteria

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

Inclusion Criteria:

  • a history of any stage new or recuurent colorectal cancer
  • great then 6 months post treatment for colorectal cancer
  • report not fully recovered from the effects of cancer and cancer treatment
  • no clinical signs or symptoms of brain metastasis
  • normal (or corrected to normal) hearing and vision
  • able to read and write English

Exclusion Criteria:

- conditions that could affect participation in yoga such as spinal disease or unstable joints

Sites / Locations

  • University of Michigan School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Yoga

Physical Activity

Usual Care

Arm Description

The Yoga Program includes two 90-minute classes every week tor a total of 12 weeks.

The Physical Activity Program includes two 90-minutes classes every week for a total of 12 weeks.The intervention is based on the Exercise for People Living with Cancer program and will include nine resistance exercises (e.g. standing push up, squats, standing leg curl) and 8 flexibility exercises (e.g. shoulder stretch, quadriceps stretch, hamstrings and lower back stretch) targeted for the whole body as well as a brief warm up and cool down (walking).

Participants randomized to this arm will receive standard care only.

Outcomes

Primary Outcome Measures

Program Evaluation
The program evaluation was developed by the investigator to measure the participant experience and satisfaction with the interventions.

Secondary Outcome Measures

Attention Network Test
The Attention Network Test is a computerized test that asks participants to determine the direction of an arrow in the center of the screen (left or right). The center arrow can be located above or below the center fixation and is accompanied by flankers and cues. Overall attention and the three networks are assessed by measuring accuracy and response times for correct answers and how response times for correct answers are influenced by flankers, alerting cues, and spatial cues.
Digit Span
Digit Span asks participants to repeat a series of numbers in the order they were given (Digit Span Forward) or reverse order (Digit Span Backward). The score is the number of digits recalled in the correct order before two failed trials. Digit Span is a test of attention and cognitive control.
Digit Symbol Substitution Test
The Digit Symbol Substitution Test provides participants with a key of numbers associated with symbols and ask participants to fill in numbered blank squares with the appropriate symbol. The score is the number of blank square filled in within 120 seconds. Digit Symbol Substitution test is a test of attention and cognitive control.
Trail Making Test
The Trail Making Test asks participants to draw a line connecting numbered circles (Part A) and a line connecting numbered circles and letters (Part B). The score is the time taken to complete the task. The Trail Making Test is a test of attention and cognitive control.
Attentional Function Index
The Attentional Function Index is a questionnaire that asks participants to rate their function on everyday tasks requiring attention and cognitive control from 0 (not at all) to 10 (extremely well or a great deal). The score is the average of 13 questions. The internal consistency ranges from 0.76 to 0.94 in individuals with cancer.
Functional Assessment of Cancer Therapy - Cognitive Function
The Functional Assessment of Cancer Therapy-Cognitive Function is a questionnaire that measures perceived cognitive function and impact on quality of life from 0 (not at all) to 4 (very much). It includes 27 items grouped into 5 subscales The internal consistency is 0.96 on each subscale in individuals with cancer.
Pro-inflammatory Markers
Serum levels of interleukin-1 beta, tumor necrosis factor-alpha, interleukin-6, interleukin-8, interleukin-12, interleukin-1 receptor antagonist, soluble tumor necrosis factor-receptor II, and c-reactive protein will be determined by cytometric bead array assay on a Luminex analyzer (MPXHYCTO-60K, Millipore; LXSAH, R & D Systems). Serum levels of neopterin will be determined by enzyme-linked immunosorbent assay (RE59821, IBL International). Blood samples will be collected between 8 am and 10 am.

Full Information

First Posted
September 23, 2015
Last Updated
December 17, 2018
Sponsor
University of Michigan
Collaborators
Oncology Nursing Society
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1. Study Identification

Unique Protocol Identification Number
NCT02564835
Brief Title
Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer
Official Title
Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Oncology Nursing Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga and to begin to assess whether yoga is effective in improving attention and immune function in individuals with colorectal cancer compared to physical activity and usual care.
Detailed Description
The proposed study will use a prospective RCT pilot design with three arms (yoga, resistance and flexibility exercise, usual care) and a total of 60 men and women who have completed therapy (> 6 months post primary or adjuvant therapy) to accomplish the specific aims. Equal numbers of men and women will be randomized into each arm of the study. Participants will be tested before, immediately after, and 3-months after treatment or similar time points for the usual care group. After data has been collected, participants who were randomized to the resistance and flexibility exercise group (active control group) or to the usual care group will be provided with the opportunity to participate in the yoga intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Research assistants at Time 2 and 3 are blinded to which arm the participant is in.
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
The Yoga Program includes two 90-minute classes every week tor a total of 12 weeks.
Arm Title
Physical Activity
Arm Type
Active Comparator
Arm Description
The Physical Activity Program includes two 90-minutes classes every week for a total of 12 weeks.The intervention is based on the Exercise for People Living with Cancer program and will include nine resistance exercises (e.g. standing push up, squats, standing leg curl) and 8 flexibility exercises (e.g. shoulder stretch, quadriceps stretch, hamstrings and lower back stretch) targeted for the whole body as well as a brief warm up and cool down (walking).
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will receive standard care only.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
The yoga curriculum in this study is based is based on the Integral Yoga approach that includes branches of yoga associated with cognitive and immune benefits (Hatha, Raja). Within the Integral Yoga approach, physical poses, breathing techniques and mediation practices were chosen to provide benefits to the nervous system, immune system, musculoskeletal system and gastrointestinal system. Poses will be adapted to individual needs. The number of repetitions and/or length of hold will be increased through standard progression.
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
The physical activity intervention is based on the Exercise for People Living with Cancer program. The intervention will include nine resistance exercises (e.g. squats) and 8 flexibility exercises (e.g. shoulder stretch) targeted for the whole body as well as a brief warm up and cool down (walking). Exercises will be adapted to individual needs. The number of repetitions and/or length of hold will increase through standard progression.
Primary Outcome Measure Information:
Title
Program Evaluation
Description
The program evaluation was developed by the investigator to measure the participant experience and satisfaction with the interventions.
Time Frame
At the end of the 12-week yoga and physical activity programs.
Secondary Outcome Measure Information:
Title
Attention Network Test
Description
The Attention Network Test is a computerized test that asks participants to determine the direction of an arrow in the center of the screen (left or right). The center arrow can be located above or below the center fixation and is accompanied by flankers and cues. Overall attention and the three networks are assessed by measuring accuracy and response times for correct answers and how response times for correct answers are influenced by flankers, alerting cues, and spatial cues.
Time Frame
Change from baseline to 6 months.
Title
Digit Span
Description
Digit Span asks participants to repeat a series of numbers in the order they were given (Digit Span Forward) or reverse order (Digit Span Backward). The score is the number of digits recalled in the correct order before two failed trials. Digit Span is a test of attention and cognitive control.
Time Frame
Change from baseline to 6 months
Title
Digit Symbol Substitution Test
Description
The Digit Symbol Substitution Test provides participants with a key of numbers associated with symbols and ask participants to fill in numbered blank squares with the appropriate symbol. The score is the number of blank square filled in within 120 seconds. Digit Symbol Substitution test is a test of attention and cognitive control.
Time Frame
Change from baseline to 6 months
Title
Trail Making Test
Description
The Trail Making Test asks participants to draw a line connecting numbered circles (Part A) and a line connecting numbered circles and letters (Part B). The score is the time taken to complete the task. The Trail Making Test is a test of attention and cognitive control.
Time Frame
Change from baseline to 6 months
Title
Attentional Function Index
Description
The Attentional Function Index is a questionnaire that asks participants to rate their function on everyday tasks requiring attention and cognitive control from 0 (not at all) to 10 (extremely well or a great deal). The score is the average of 13 questions. The internal consistency ranges from 0.76 to 0.94 in individuals with cancer.
Time Frame
Change from baseline to 6 months
Title
Functional Assessment of Cancer Therapy - Cognitive Function
Description
The Functional Assessment of Cancer Therapy-Cognitive Function is a questionnaire that measures perceived cognitive function and impact on quality of life from 0 (not at all) to 4 (very much). It includes 27 items grouped into 5 subscales The internal consistency is 0.96 on each subscale in individuals with cancer.
Time Frame
Change from baseline to 6 months
Title
Pro-inflammatory Markers
Description
Serum levels of interleukin-1 beta, tumor necrosis factor-alpha, interleukin-6, interleukin-8, interleukin-12, interleukin-1 receptor antagonist, soluble tumor necrosis factor-receptor II, and c-reactive protein will be determined by cytometric bead array assay on a Luminex analyzer (MPXHYCTO-60K, Millipore; LXSAH, R & D Systems). Serum levels of neopterin will be determined by enzyme-linked immunosorbent assay (RE59821, IBL International). Blood samples will be collected between 8 am and 10 am.
Time Frame
Change from baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Attendance Log
Description
The attendance log was developed by the investigator to measure adherence to the intervention and dose of the intervention received. Participants sign the attendance log at each yoga or physical activity class
Time Frame
Throughout the 12-week program.
Title
Adherence and Attrition Log
Description
The adherence and attrition log was developed by the investigator to describe reasons for not attending a class or dropping out of study. Participants will be asked if they would like to tell research team reason for missing a class or dropping out (e.g. too busy) so we can improve the intervention.
Time Frame
From date of signed informed consent until last yoga/physical activity class or research visit - up to 6 months
Title
Safety Log
Description
The safety log was developed by the investigator to describe any adverse event related to the yoga and physical activity programs.
Time Frame
At each yoga and physical activity class throughout the 12-week program
Title
Demographic and Medical Information Questionnaires
Description
The demographic and medical information questionnaires were developed by the investigator to describe sample characteristics (such as age and stage of disease).
Time Frame
At baseline before randomization to study arm
Title
Profile of Mood States-Brief Form
Description
The Profile of Mood States-Brief Form asks participants to rate how they have been feeling (e.g. tense) in the past week on a scale of 0 (not at all) to 4 (extremely). The anxiety and depressed mood subscales will be used to describe the sample. Each subscale has five items and the score is the sum of the five items. The internal consistency of the anxiety and depressed mood subscales range from 0.86 to 0.93 in individuals with cancer.
Time Frame
Change from baseline to 6 months
Title
Mindful Attention Awareness Scale
Description
The Mindful Attention Awareness Scale will be used to assess cognitive training or uptake of the yoga intervention. The questionnaire has 15 items and measures the frequency of mindful states in cancer.
Time Frame
Changes from baseline to 6 monts
Title
Beliefs about Treatment
Description
The Benefits about Treatment Question was developed by investigators at University of California, Los Angeles to assess a participant's expectations about the yoga and physical activity interventions and their effect on outcomes.
Time Frame
Changes from baseline to end of 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a history of any stage new or recuurent colorectal cancer great then 6 months post treatment for colorectal cancer report not fully recovered from the effects of cancer and cancer treatment no clinical signs or symptoms of brain metastasis normal (or corrected to normal) hearing and vision able to read and write English Exclusion Criteria: - conditions that could affect participation in yoga such as spinal disease or unstable joints
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moira Visovatti, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Nursing
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

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