Mind-Body Program for Cancer Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neoplasms |
Behavioral: Mind-Body Psychotherapy Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients |
- Functional Assessment of Cancer Therapy [ Time Frame: baseline to 2 months and 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Psycho-educational / Stress Management group
|
Behavioral: Mind-Body Psychotherapy Group
Psycho-educational group
Other Name: Stress Management Group
|
|
Active Comparator: 2
Spiritual-Existential Support Group
|
Behavioral: Mind-Body Psychotherapy Group
Spiritual-Existential Group
Other Name: Spiritual Support Group
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Alyson Moadel, Ph.D. | 718-430-2696 | alyson.moadel@einstein.yu.edu |
| United States, New York | |
| Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Alyson Moadel, Ph.D. 718-430-2696 alyson.moadel@einstein.yu.edu | |
| Principal Investigator: Alyson Moadel, Ph.D. | |
| Principal Investigator: | Alyson Moadel, Ph.D. | Albert Einstein College of Medicine of Yeshiva University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alyson Moadel, Associate Professor, Albert Einstein College of Medicine of Yeshiva University |
| ClinicalTrials.gov Identifier: | NCT00179387 History of Changes |
| Other Study ID Numbers: | IRB #2003-412, ACS Research Scholar's Grant |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
|
Neoplasms Needs Assessment Adaptation Psychological Minority Groups |
Psychotherapy, Group Program Evaluation Spirituality Spiritual Therapies |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013