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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Counselling based on yoga
Chemotherapy
Sponsored by
NMP Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

40 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Yoga Counselling Group

    Usual Care Group

    Arm Description

    Yoga based psychological counselling delivered individually and in group along with conventional care

    Usual care provided to patients

    Outcomes

    Primary Outcome Measures

    Anxiety and Depression
    Depression and anxiety as assessed by Hospital Anxiety Depression Scale

    Secondary Outcome Measures

    Quality of Life
    Quality of life as assessed by WHO quality of life-BREF

    Full Information

    First Posted
    May 2, 2018
    Last Updated
    May 2, 2018
    Sponsor
    NMP Medical Research Institute
    Collaborators
    Warwick Research Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03524391
    Brief Title
    Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients
    Official Title
    Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients: Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 12, 2016 (Actual)
    Primary Completion Date
    January 5, 2017 (Actual)
    Study Completion Date
    February 25, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NMP Medical Research Institute
    Collaborators
    Warwick Research Services

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga Counselling Group
    Arm Type
    Experimental
    Arm Description
    Yoga based psychological counselling delivered individually and in group along with conventional care
    Arm Title
    Usual Care Group
    Arm Type
    Active Comparator
    Arm Description
    Usual care provided to patients
    Intervention Type
    Behavioral
    Intervention Name(s)
    Counselling based on yoga
    Intervention Description
    Counseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy
    Intervention Description
    Usual Care group had standard chemotherapy regimens
    Primary Outcome Measure Information:
    Title
    Anxiety and Depression
    Description
    Depression and anxiety as assessed by Hospital Anxiety Depression Scale
    Time Frame
    Change from baseline to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of Life
    Description
    Quality of life as assessed by WHO quality of life-BREF
    Time Frame
    Change from baseline to 12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neha Sharma, PhD
    Organizational Affiliation
    Warwick Research Services
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Dhruv Singh
    Organizational Affiliation
    NMP Medical Research Institute, India
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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