NCT01156935

Brief Summary

Previous studies report low levels of mood and of quality of life among cancer patients. Laugh has been proved to improve mood and immune system function. The investigators propose to assess in a prospective randomised case-control study the affects of laugh-yoga intervention on mood levels and quality of life among cancer patients in a cancer clinic. The main hypothesis is that patients in laugh-yoga group will report higher mood and quality o life levels after intervention in comparison with no-intervention group. The second hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on mood and quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 12, 2010

Status Verified

July 1, 2010

Enrollment Period

2 months

First QC Date

July 1, 2010

Last Update Submit

July 9, 2010

Conditions

Neoplasms

Keywords

NeoplasmLaugh-YogaMoodQuality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Questionnaire - QLQ-C30 & Positive-Negative Affect

    Participants will fill QLQ-C30 & Positive -Negative Affect will be assessed before intervention and after three laugh - yoga sessions (that is after three weeks)

Secondary Outcomes (1)

  • Blood analysis for WBC, CRP, T&B Lymphocytes

    Before intervention and after three laugh-yoga interventions, that is after three weeks.

Study Arms (1)

Laugh yoga

EXPERIMENTAL

experimental laugh yoga

Other: Laugh Yoga

Interventions

Laugh YogaOTHER

1 hour including laugh, respiratory exercises and guided imagination by a group instructor specialized in laugh yoga

Laugh yoga

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • oncologic patients treated in oncologic clinic in Wolfson MC,
  • must be able to participate in Laugh Yoga session

You may not qualify if:

  • psychiatric or cognitive impairment,
  • deterioration in physical status,
  • treatment discontinuation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 5, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

July 12, 2010

Record last verified: 2010-07