Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564835
• Other study ID #: HUM00096913
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Other:
• Yoga
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.
• Physical Activity
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.

Locations

Country	Name	City	State
United States	University of Michigan School of Nursing	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Oncology Nursing Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attendance Log	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	Throughout the 12-week program.
Other	Adherence and Attrition Log	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.	From date of signed informed consent until last yoga/physical activity class or research visit - up to 6 months
Other	Safety Log	The safety log was developed by the investigator to describe any adverse event related to the yoga and physical activity programs.	At each yoga and physical activity class throughout the 12-week program
Other	Demographic and Medical Information Questionnaires	The demographic and medical information questionnaires were developed by the investigator to describe sample characteristics (such as age and stage of disease).	At baseline before randomization to study arm
Other	Profile of Mood States-Brief Form	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.	Change from baseline to 6 months
Other	Mindful Attention Awareness Scale	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.	Changes from baseline to 6 monts
Other	Beliefs about Treatment	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.	Changes from baseline to end of 12-week intervention
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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