NCT03220945

Brief Summary

This randomized pilot trial studies the effect of comprehensive yoga program (SKY) in reducing stress, pain, and fatigue, and improving psychological well-being in patients with prostate cancer. SKY is one of the most widely used breathing techniques derived from yoga. SKY Yoga may improve quality of life in patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

7.3 years

First QC Date

July 14, 2017

Last Update Submit

June 20, 2024

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (5)

  • Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS)

    HADS is a 14-item self-rating scale that measures anxiety and depression. HADS will be compared before and after intervention.

    15 weeks after study start

  • Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30)

    European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) is a cancer-specific 30-item questionnaire incorporating 5-functioning scales, a global health-status/QOL scale and symptoms assessment.

    15 weeks after study start

  • Change in psychological well-being as defined in the Life Orientation Test-Revised (LOT-R)

    LOT-R is a 10-item self-report scale that measures the expectations about positive outcome in general.

    15 weeks after study start

  • Change in fatigue as defined in 36-item short-form health survey (SF-36) vitality scale

    SF-36 is a reliable and valid measure of energy/fatigue in the past month.

    15 weeks after study start

  • Change in pain based on brief pain inventory - short form

    Pain will be assessed with the brief pain inventory - short form (BPI-SF) questionnaire.

    15 weeks after study start

Secondary Outcomes (5)

  • Change in antioxidant status: superoxide dismutase

    15 weeks after study start

  • Change in antioxidant status: glutathione peroxidase

    15 weeks after study start

  • Change in serum 8-isoprostane

    15 weeks after study start

  • Change in saliva cortisol

    15 weeks after study start

  • Change in hair cortisol

    15 weeks after study start

Study Arms (2)

Arm I (Control group)

NO INTERVENTION

Patients may receive yoga instruction for 1 week after post-test 2.

Arm II (Yoga group)

EXPERIMENTAL

Patients receive yoga instruction over approximately 3 hours daily for 5 days of week 1 and over 2 hours once a week of weeks 2-13.

Other: Yoga

Interventions

YogaOTHER

Receive yoga instruction

Also known as: Yoga Therapy
Arm II (Yoga group)

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having finished radiotherapy at least two months ago
  • Ability to speak and read English and give informed consent
  • Have an interest in being part of a study to evaluate yoga-derived exercises and eager to practice some kind of relaxation exercise daily for 3 months

You may not qualify if:

  • Have a diagnosis of psychiatric illness or other major illness in addition to PCa, such as other cancers, uncontrolled hypertension, lung disease, liver disease or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Omer Kucuk, MD

    Emory University/Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

January 6, 2016

Primary Completion

April 27, 2023

Study Completion

April 27, 2023

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations

US(2)