- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754529
Yoga Intervention for the Improvement of Cancer-Related Stress in Cancer Survivors
Influence of Yoga on Cancer-Related Stress in Cancer Survivors
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To develop and test the feasibility of a standardized 12-week online hatha yoga intervention (n=30) of breathing and movement incorporating both restorative poses, breathing techniques, guided meditation.
SECONDARY OBJECTIVES:
I. To evaluate the yoga intervention in relation to self-reported levels of stress and quality of life in cancer survivors (n=30).
II. Feasibility of collecting blood and saliva at baseline and post-intervention for stress biomarkers, including cortisol and norepinephrine.
EXPLORATORY OBJECTIVE:
I. To determine how behavior change, quality of life (QoL), and biomarkers of adrenergic stress, inflammation, and immunosuppression are affected by a 12-week online yoga program completed by cancer survivors.
OUTLINE:
Patients receive online yoga intervention once a week (QW) for 12 weeks.
After completion of study, patients are followed up at 3 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >= 18 years of age
- Have been diagnosed with a cancer and have finished treatment
- Have been cleared for physical activity by a physician or nurse practitioner (physician or nurse practitioner name and date clearance received)
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Unwilling or unable to complete the assessment in English
- Are pregnant or nursing
- Are unwilling or unable to follow protocol requirements
- Have skeletal instabilities and/or cardio-pulmonary comorbidities
- Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive care (yoga)
Patients receive online yoga intervention QW for 12 weeks.
|
Ancillary studies
Other Names:
Ancillary studies
Receive yoga intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of subjects who participate or show high adherence to the intervention
Time Frame: Up to 12 weeks
|
Will be presented as observed proportion and 95% Clopper-Pearson confidence intervals (CIs).
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of the intervention in stress-reduction
Time Frame: Up to 3 months post-intervention
|
Serum cortisol and norepinephrine levels will be measured by blood collection
|
Up to 3 months post-intervention
|
|
Efficacy of the intervention in stress-reduction
Time Frame: Up to 3 months post intervention
|
Self report stress
|
Up to 3 months post intervention
|
|
Efficacy of the intervention in stress reduction
Time Frame: Up to 3 months post intervention
|
salivary cortisol will be measured by saliva collection
|
Up to 3 months post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of life
Time Frame: Up to 3 months post-intervention
|
Quality of life collected by the EORTC Quality of Life Questionnaire
|
Up to 3 months post-intervention
|
|
Change in Cognitive function
Time Frame: Up to 12 weeks
|
Cognitive function will be assessed by standard questionnaires
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathryn Glaser, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 891720 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2021-00698 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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