A Pilot Study To Assess Guidance in and Subsequent Use of Mind-Body Techniques on the Quality of Life of Cancer Patients
NCT ID: NCT01586546
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
32 participants
INTERVENTIONAL
2012-05-31
2012-12-01
Brief Summary
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Value of Study: Technological advances have contributed to new venues for healthcare delivery. It is imperative that these new delivery methods, for individual and/or group psychosocial services are sufficiently tested and validated. Research shows that there is very little knowledge about differences in communication styles between online and face-to-face groups, nor is there much knowledge on the overall efficacy of online groups.
Phenomenon Studied: Can MBM skills groups improve the quality of life of cancer patients? Is there a difference in outcome between a MBM skills group delivered face-to-face and a MBM skills group delivered online.
Reasons Leading to Proposing the Project: Despite encouraging research showing that psychosocial interventions have positive effects in the lives of cancer patients, more research is needed due to several problems of current research, such as poor study design, lack of use of technological advances and relatively few existing studies on the effectiveness of MBM therapies in the oncological setting.
Stated Hypothesis:
Hypothesis 1:
There is no difference between baseline QOL measures and QOL measures at the end of face-to-face facilitated MBM skills groups.
Hypothesis 2:
There is no difference between baseline QOL measures and QOL measures at the end of Online facilitated MBM skills groups.
Hypothesis 3:
Participation in either, online facilitated MBM skills groups or face-to-face facilitated MBM skills groups will improve QOL measures when compared to control group.
Hypothesis 4:
Patients in the control group (waitlist control, care as usual group) will have no improvement on QOL measures.
Anticipated Value to the Larger Community: According to the National Center for Complementary and Alternative Medicine (NCCAM) "…there is a need for reliable, objective, evidence-based information regarding the usefulness and safety-or lack thereof-of CAM" (National Center for Complementary and Alternative Medicine, 2011, p.3). This study will add to general scientific knowledge of CAM and MBM.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Face-to-Face MBM Skills Group
Face-to-Face MBM Skills Group
Mind Body Medicine (MBM) Skills Groups provide a means for study participants to learn skills for taking care of themselves in a supportive small group setting. Participants will learn and practice a variety of specific MBM skills. These MBM skills will enable a participant to change the way she/he deals with the wide range of stressors at different stages of her/his cancer journey. Some of these MBM skills are meditation, guided imagery, biofeedback, writing, and drawing. These groups are designed to assist a participant in coming to know themselves better and in learning and using these tools that will help the participant to deal with the distress as only a small percentage of cancer patients in distress receive appropriate support.
Online MBM Skills Group
Online MBM Skills Group
Mind Body Medicine (MBM) Skills Groups provide a means for study participants to learn skills for taking care of themselves in a supportive small group setting. Participants will learn and practice a variety of specific MBM skills. These MBM skills will enable a participant to change the way she/he deals with the wide range of stressors at different stages of her/his cancer journey. Some of these MBM skills are meditation, guided imagery, biofeedback, writing, and drawing. These groups are designed to assist a participant in coming to know themselves better and in learning and using these tools that will help the participant to deal with the distress as only a small percentage of cancer patients in distress receive appropriate support.
Waitlist Control I
This group will be given the option to participate in a face-to-face MBM skills group intervention after conclusion of study.
Waitlist Control I
No intervention offered during study period. Intervention is offered after completion of study.
Waitlisted Control II
This group will be given the option to participate in an Online MBM skills group intervention after conclusion of study.
Waitlist Control II
No intervention offered during study period. Intervention is offered after completion of study.
Interventions
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Face-to-Face MBM Skills Group
Mind Body Medicine (MBM) Skills Groups provide a means for study participants to learn skills for taking care of themselves in a supportive small group setting. Participants will learn and practice a variety of specific MBM skills. These MBM skills will enable a participant to change the way she/he deals with the wide range of stressors at different stages of her/his cancer journey. Some of these MBM skills are meditation, guided imagery, biofeedback, writing, and drawing. These groups are designed to assist a participant in coming to know themselves better and in learning and using these tools that will help the participant to deal with the distress as only a small percentage of cancer patients in distress receive appropriate support.
Waitlist Control I
No intervention offered during study period. Intervention is offered after completion of study.
Waitlist Control II
No intervention offered during study period. Intervention is offered after completion of study.
Online MBM Skills Group
Mind Body Medicine (MBM) Skills Groups provide a means for study participants to learn skills for taking care of themselves in a supportive small group setting. Participants will learn and practice a variety of specific MBM skills. These MBM skills will enable a participant to change the way she/he deals with the wide range of stressors at different stages of her/his cancer journey. Some of these MBM skills are meditation, guided imagery, biofeedback, writing, and drawing. These groups are designed to assist a participant in coming to know themselves better and in learning and using these tools that will help the participant to deal with the distress as only a small percentage of cancer patients in distress receive appropriate support.
Eligibility Criteria
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Inclusion Criteria
* Tumors staged according to the Ann Arbor staging classification system (commonly lymphomas)
* Tumors which don't have a clear-cut staging system such as most types of leukemia and blood or bone marrow cancers
* Tumors staged by the International Federation of Gynecology and Obstetrics (cervix, uterus, ovary, vagina, and vulva).
* No neurological illness
Exclusion Criteria
* Not being able to speak or understand English;
* No access to reliable computer with operational software to participate in online video conferences
* Unavailability of built-in or external web-cam
* Unavailability of reliable high-speed Internet connection
* Unavailability of reliable transportation to and from face-to-face MBM skills group meetings
* Barring unforeseen circumstances, intent to participate in each and every one of the eight MBM Skills Groups session
18 Years
ALL
No
Sponsors
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Absenger Cancer Education Foundation
OTHER
Responsible Party
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Principal Investigators
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Werner Absenger, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Absenger Cancer Education Foundation, Spring Lake, Michigan & Saybrook University's College of Mind-Body Medicine, San Francisco, California
Locations
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Absenger Cancer Education Foundation
Spring Lake, Michigan, United States
Countries
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Related Links
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Absenger Cancer Education Foundation Homepage
Other Identifiers
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MBM 5538
Identifier Type: -
Identifier Source: org_study_id
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