Yoga Intervention for the Improvement of Cancer-Related Stress in Cancer Survivors

Malignant Solid Neoplasm Clinical Trial

Official title:

Influence of Yoga on Cancer-Related Stress in Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754529
• Other study ID #: I 891720
• Secondary ID: NCI-2021-00698I
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: May 11, 2024

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 11, 2024
• Est. primary completion date: May 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Ancillary studies
• Yoga
Receive yoga intervention

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of life	Quality of life collected by the EORTC Quality of Life Questionnaire	Up to 3 months post-intervention
Other	Change in Cognitive function	Cognitive function will be assessed by standard questionnaires	Up to 12 weeks
Primary	Proportion of subjects who participate or show high adherence to the intervention	Will be presented as observed proportion and 95% Clopper-Pearson confidence intervals (CIs).	Up to 12 weeks
Secondary	Efficacy of the intervention in stress-reduction	Serum cortisol and norepinephrine levels will be measured by blood collection	Up to 3 months post-intervention
Secondary	Efficacy of the intervention in stress-reduction	Self report stress	Up to 3 months post intervention
Secondary	Efficacy of the intervention in stress reduction	salivary cortisol will be measured by saliva collection	Up to 3 months post intervention