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
About this trial
This is an interventional supportive care trial for Prostate Cancer
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.
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
NCT ID
NCT03524391
First Posted
May 2, 2018
Last Updated
May 2, 2018
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services
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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