Mind-Body Program for Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00179387
First received: September 13, 2005
Last updated: February 1, 2012
Last verified: February 2012

September 13, 2005
February 1, 2012
December 2004
September 2012   (final data collection date for primary outcome measure)
Functional Assessment of Cancer Therapy [ Time Frame: baseline to 2 months and 4 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00179387 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Mind-Body Program for Cancer Patients
Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients

The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.

Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Neoplasms
  • Behavioral: Mind-Body Psychotherapy Group
    Psycho-educational group
    Other Name: Stress Management Group
  • Behavioral: Mind-Body Psychotherapy Group
    Spiritual-Existential Group
    Other Name: Spiritual Support Group
  • Active Comparator: 1
    Psycho-educational / Stress Management group
    Intervention: Behavioral: Mind-Body Psychotherapy Group
  • Active Comparator: 2
    Spiritual-Existential Support Group
    Intervention: Behavioral: Mind-Body Psychotherapy Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • On Active Treatment for:

Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III & IV, or All Other Cancers (ANY stage on treatment)

  • Language is English or Spanish

Exclusion Criteria:

  • Patient is currently attending other support/psychotherapy group
  • Significant Cognitive Impairment
  • ECOG performance status = 3 or 4
  • Current major untreated psychiatric disorder
  • Unable to attend intervention in following 8 weeks due to medical or practical restrictions
Both
18 Years and older
No
Contact: Alyson Moadel, Ph.D. 718-430-2696 alyson.moadel@einstein.yu.edu
United States
 
NCT00179387
IRB #2003-412, ACS Research Scholar's Grant
Yes
Alyson Moadel, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
American Cancer Society, Inc.
Principal Investigator: Alyson Moadel, Ph.D. Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP