A Pilot Study To Assess Guidance in and Subsequent Use of Mind-Body Techniques on the Quality of Life of Cancer Patients

NCT01586546 | Terminated

• 1 other identifier: MBM 5538
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To answer the questions of whether a Mind-Body Medicine (MBM) skills group facilitated face-to-face and online can improve measures of Quality of Life (QOL) in a population of cancer patients. 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.

Conditions

Quality of Life; Life Change Events; Neoplasms

Keywords

Mind-body; Psychosocial; Meditation; Breathing Exercises; Guided Imagery; Visualization

Outcome Measures

Primary Outcomes (1)

• Change in Quality Of Life, as assessed by the World Health Organization Quality of Life (WHOQOL-BREF) instrument

  The WHOQOL-BREF is a 26-item version of the WHOQOL-100 assessment. The instrument has been tested and developed for almost 20 years and "…results indicate that overall, the WHOQOL-BREF is a sound, cross-culturally valid assessment of QOL, as reflected by its four domains: physical, psychological, social and environment" (Skevington, Lofty, \& O'Connell, 2004).

  Baseline, week 4

Secondary Outcomes (1)

• Change in distress, anxiety, depression and need for help as assessed by the Emotion Thermometers Tool© (ET5)

  Baseline, Week 4

Study Arms (4)

Face-to-Face MBM Skills Group

EXPERIMENTAL

Behavioral: Face-to-Face MBM Skills Group

Online MBM Skills Group

EXPERIMENTAL

Behavioral: Online MBM Skills Group

Waitlist Control I

OTHER

This group will be given the option to participate in a face-to-face MBM skills group intervention after conclusion of study.

Other: Waitlist Control I

Waitlisted Control II

OTHER

This group will be given the option to participate in an Online MBM skills group intervention after conclusion of study.

Other: Waitlist Control II

Interventions

Face-to-Face MBM Skills Group BEHAVIORAL

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.

Face-to-Face MBM Skills Group

Waitlist Control I OTHER

No intervention offered during study period. Intervention is offered after completion of study.

Waitlist Control I

Waitlist Control II OTHER

No intervention offered during study period. Intervention is offered after completion of study.

Waitlisted Control II

Online MBM Skills Group BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TNM staged tumors Stage I to Stage IV,
• 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

You may not qualify if:

• Mental functioning clinically estimated to be below the low average range (IQ\< 80). (Impaired cognitive level might impede verbal comprehension).
• 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

Sponsors & Collaborators

• Absenger Cancer Education Foundation: lead

Study Sites (1)

Absenger Cancer Education Foundation

Spring Lake, Michigan, 49456, United States

Location

Related Links

• Absenger Cancer Education Foundation Homepage

MeSH Terms

Conditions

Neoplasms

Study Officials

• Werner Absenger, M.Sc.

  Absenger Cancer Education Foundation, Spring Lake, Michigan & Saybrook University's College of Mind-Body Medicine, San Francisco, California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 27, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

US (1)