Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Other: Yoga
* Other: Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>The Yoga Program includes two 90-minute classes every week tor a total of 12 weeks. | Other: Yoga<br>* 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.<br>|
| Active Comparator: Physical Activity<br>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). | Other: Physical Activity<br>* 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.<br>|
| No Intervention: Usual Care<br>Participants randomized to this arm will receive standard care only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Evaluation | The program evaluation was developed by the investigator to measure the participant experience and satisfaction with the interventions. | At the end of the 12-week yoga and physical activity programs. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 6 months. | 
| 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. | Change from baseline to 6 months | 
| 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. | Change from baseline to 6 months | 
| 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. | Change from baseline to 6 months | 
| 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. | Change from baseline to 6 months | 
| 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. | Change from baseline to 6 months | 
| 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. | Change from baseline to 6 months |