NCT03728205

Brief Summary

The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

October 29, 2018

Last Update Submit

April 23, 2021

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

  • The feasibility of implementing Eischens yoga interventions for solid tumor cancer patients undergoing radiation therapy. This will be measured by the success rate of recruitment and retention for 10 subjects.

    Feasibility

    12 months

Secondary Outcomes (2)

  • Effects on fatigue

    12 months

  • Effects on Stress Level

    12 Months

Other Outcomes (1)

  • Long Term

    17 months

Study Arms (1)

Observational

EXPERIMENTAL

All 10 pilot subjects will be taking yoga

Behavioral: Yoga

Interventions

YogaBEHAVIORAL

Twice weekly yoga sessions for 12 weeks

Observational

Eligibility Criteria

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

You may qualify if:

  • Stage I and II Cancer patients with solid tumors undergoing RT for 4-8 weeks (external beam radiation).
  • Patients of age \>18, and all races will be included in the study.
  • All patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Pennsylvania.
  • Patients must be English speaking.
  • Patients must be able to attend the schedule classes.

You may not qualify if:

  • Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders.
  • Patients with metastatic disease.
  • Active smokers. Smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Self-reporting smokers that have been smoke free for 6 months may be included)
  • Patients who currently practice or have recently practiced yoga (had not taken a yoga class on a regular bases in the last 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 2, 2018

Study Start

December 15, 2018

Primary Completion

December 31, 2020

Study Completion

January 14, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations

US(1)