NCT01985945

Brief Summary

The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of 20 women with stage I and II breast cancer receiving radiation therapy treatment, while a second cohort of the same type of and number of patients who, instead of yoga will receive standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several points.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

November 11, 2013

Last Update Submit

March 10, 2020

Conditions

Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    One Year

Study Arms (2)

Yoga

OTHER
Other: Yoga

Without Yoga

NO INTERVENTION

Interventions

YogaOTHER
Yoga

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage I and II breast cancer patients undergoing active radiation therapy
  • Above the age of 18
  • Must sign informed consent form
  • Must speak English
  • Only women are eligible

You may not qualify if:

  • Patients with medical restrictions that may interfere with yoga participation per their physicians' decision
  • Those who have smoked in the last 6 months because smoking can interfere with the breathing and relaxation techniques of yoga.
  • Those who have regularly taken yoga in the last 6 months, because they would not come to the intervention with the same baseline as other participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Gary Freedman, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 31, 2015

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

US(1)