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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524391
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Warwick Research Services
Information provided by (Responsible Party):
NMP Medical Research Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Counselling based on yoga Drug: Chemotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients: Randomized Control Trial
Actual Study Start Date : February 12, 2016
Actual Primary Completion Date : January 5, 2017
Actual Study Completion Date : February 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety and Depression [ Time Frame: Change from baseline to 12 weeks ]
    Depression and anxiety as assessed by Hospital Anxiety Depression Scale


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Change from baseline to 12 weeks ]
    Quality of life as assessed by WHO quality of life-BREF


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524391


Sponsors and Collaborators
NMP Medical Research Institute
Warwick Research Services
Investigators
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Study Director: Neha Sharma, PhD Warwick Research Services
Principal Investigator: Dhruv Singh NMP Medical Research Institute, India
More Information
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Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT03524391    
Other Study ID Numbers: NMP/10123
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases