Clinical trial NCT02564835: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2015-10-01
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Program Evaluation
timeFrame: At the end of the 12-week yoga and physical activity programs.
Secondary outcomes:
measure: Attention Network Test
timeFrame: Change from baseline to 6 months.
measure: Digit Span
timeFrame: Change from baseline to 6 months
measure: Digit Symbol Substitution Test
timeFrame: Change from baseline to 6 months
measure: Trail Making Test
timeFrame: Change from baseline to 6 months
measure: Attentional Function Index
timeFrame: Change from baseline to 6 months
measure: Functional Assessment of Cancer Therapy - Cognitive Function
timeFrame: Change from baseline to 6 months
measure: Pro-inflammatory Markers
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Attendance Log
timeFrame: Throughout the 12-week program.
measure: Adherence and Attrition Log
timeFrame: From date of signed informed consent until last yoga/physical activity class or research visit - up to 6 months
measure: Safety Log
timeFrame: At each yoga and physical activity class throughout the 12-week program
measure: Demographic and Medical Information Questionnaires
timeFrame: At baseline before randomization to study arm
measure: Profile of Mood States-Brief Form
timeFrame: Change from baseline to 6 months
measure: Mindful Attention Awareness Scale
timeFrame: Changes from baseline to 6 monts
measure: Beliefs about Treatment
timeFrame: Changes from baseline to end of 12-week intervention
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan
name: Moira Visovatti, PhD
role: PRINCIPAL_INVESTIGATOR
References: