Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients

May 2, 2018 updated by: NMP Medical Research Institute

Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients: Randomized Control Trial

Cancer is second leading cause of death worldwide. The psychological issues are related to all stages of the disease affecting outcome of treatment and overall quality of life. The study evaluated the effectiveness of yoga counselling among prostate cancer patients on their quality of life and psychological outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Primary diagnosis of Prostate Cancer
  • Sign a consent form allowing related information to be included in this research.

Exclusion Criteria:

  • Have pre-existing diagnosed psychiatric conditions
  • Currently taking psychotropic medications
  • Have been diagnosed with cancer other than prostate cancer
  • Evidence of active substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga Counselling Group
Yoga based psychological counselling delivered individually and in group along with conventional care
Behavioral: Counselling based on yoga
Counseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy.
Drug: Chemotherapy
Usual Care group had standard chemotherapy regimens
Active Comparator: Usual Care Group
Usual care provided to patients
Drug: Chemotherapy
Usual Care group had standard chemotherapy regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression
Time Frame: Change from baseline to 12 weeks
Depression and anxiety as assessed by Hospital Anxiety Depression Scale
Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Change from baseline to 12 weeks
Quality of life as assessed by WHO quality of life-BREF
Change from baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMP Medical Research Institute

Collaborators

Warwick Research Services

Investigators

  • Principal Investigator: Dhruv Singh, NMP Medical Research Institute, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2016

Primary Completion (Actual)

January 5, 2017

Study Completion (Actual)

February 25, 2017

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMP/10123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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