Prostate CancerNCT03524391
Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients
A study testing Counselling based on yoga and Chemotherapy in people with Prostate Cancer, run by NMP Medical Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Counselling based on yoga and Chemotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2016to 25 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of Prostate Cancer
- Sign a consent form allowing related information to be included in this research.
Who cannot join
- Have pre-existing diagnosed psychiatric conditions
- Currently taking psychotropic medications
- Have been diagnosed with cancer other than prostate cancer
- Evidence of active substance abuse.
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Counselling based on yoga, Chemotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling based on yogaBehavioural
Counseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy.
ChemotherapyDrug
Usual Care group had standard chemotherapy regimens
| Study group | Role | What they receive |
|---|---|---|
| Yoga Counselling Group | Experimental | Yoga based psychological counselling delivered individually and in group along with conventional care Receives: Behavioral: Counselling based on yoga; Drug: Chemotherapy |
| Usual Care Group | Active comparator | Usual care provided to patients Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depression
Depression and anxiety as assessed by Hospital Anxiety Depression Scale
Measured: Change from baseline to 12 weeks
Secondary outcomes (1)
Quality of Life
Quality of life as assessed by WHO quality of life-BREF
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start12 Feb 2016
- Primary completion5 Jan 2017
- Study completion25 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Study director, Warwick Research ServicesDhruv Singh, Principal investigator, NMP Medical Research Institute, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524391
- Sponsor's protocol ID
- NMP/10123
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03524391
- Acronym / sponsor ID
- NMP/10123
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 25 Feb 2017 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Counselling Group | Experimental | Behavioral: Counselling based on yoga, Drug: ChemotherapyYoga based psychological counselling delivered individually and in group along with conventional care |
| Usual Care Group | Active comparator | Drug: ChemotherapyUsual care provided to patients |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primary diagnosis of Prostate Cancer
- Sign a consent form allowing related information to be included in this research.
Key exclusion criteria (4 listed)
- Have pre-existing diagnosed psychiatric conditions
- Currently taking psychotropic medications
- Have been diagnosed with cancer other than prostate cancer
- Evidence of active substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselling based on yogaCounseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy. | Behavioural | Yoga Counselling Group |
| ChemotherapyUsual Care group had standard chemotherapy regimens | Drug | Usual Care Group, Yoga Counselling Group |
Primary outcome
Anxiety and Depression
Time frame: Change from baseline to 12 weeks
Depression and anxiety as assessed by Hospital Anxiety Depression Scale
1 secondary outcome
Quality of Life
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, PhD study director
Warwick Research Services
Dhruv Singh principal investigator
NMP Medical Research Institute, India
Questions about this trial
What is this clinical trial studying?
A study testing Counselling based on yoga and Chemotherapy in people with Prostate Cancer, run by NMP Medical Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and Depression (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.