Clinical trial NCT04754529: Yoga Intervention for the Improvement of Cancer-Related Stress in Cancer Survivors
Official title: Influence of Yoga on Cancer-Related Stress in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial develops and test a yoga intervention in improving cancer-related stress in cancer survivors. The online hatha yoga intervention of breathing and movement incorporates both restorative poses, breathing techniques, guided meditation and may reduce stress levels and improve overall quality of health in cancer survivors.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who participate or show high adherence to the intervention
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Efficacy of the intervention in stress-reduction
timeFrame: Up to 3 months post-intervention
measure: Efficacy of the intervention in stress-reduction
timeFrame: Up to 3 months post intervention
measure: Efficacy of the intervention in stress reduction
timeFrame: Up to 3 months post intervention
Other outcomes:
measure: Change in Quality of life
timeFrame: Up to 3 months post-intervention
measure: Change in Cognitive function
timeFrame: Up to 12 weeks
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Kathryn Glaser
role: PRINCIPAL_INVESTIGATOR
References: