NCT03524391

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable prostate-cancer

Status
completed

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

Study Start

First participant enrolled

February 12, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

May 2, 2018

Last Update Submit

May 2, 2018

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Anxiety and Depression

    Depression and anxiety as assessed by Hospital Anxiety Depression Scale

    Change from baseline to 12 weeks

Secondary Outcomes (1)

  • Quality of Life

    Change from baseline to 12 weeks

Study Arms (2)

Yoga Counselling Group

EXPERIMENTAL

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

Behavioral: Counselling based on yogaDrug: Chemotherapy

Usual Care Group

ACTIVE COMPARATOR

Usual care provided to patients

Drug: Chemotherapy

Interventions

Counselling based on yogaBEHAVIORAL

Counseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy.

Yoga Counselling Group
ChemotherapyDRUG

Usual Care group had standard chemotherapy regimens

Usual Care GroupYoga Counselling Group

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR

  • Dhruv Singh

    NMP Medical Research Institute, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 14, 2018

Study Start

February 12, 2016

Primary Completion

January 5, 2017

Study Completion

February 25, 2017

Last Updated

May 14, 2018

Record last verified: 2018-05