Clinical trial NCT01586546: A Pilot Study To Assess Guidance in and Subsequent Use of Mind-Body Techniques on the Quality of Life of Cancer Patients
Official title: Quality of Life Outcomes Following Mind-body Skills Training for Cancer Patients That Are Facilitated Either Face-to-face or Online: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quality of Life
Life Change Events
Neoplasms
Keywords: Mind-body
Psychosocial
Meditation
Breathing Exercises
Guided Imagery
Visualization
Lead sponsor: Absenger Cancer Education Foundation
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Quality Of Life, as assessed by the World Health Organization Quality of Life (WHOQOL-BREF) instrument
timeFrame: Baseline, week 4
Secondary outcomes:
measure: Change in distress, anxiety, depression and need for help as assessed by the Emotion Thermometers Tool© (ET5)
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Spring Lake
country: United States
facility: Absenger Cancer Education Foundation
state: Michigan
Study officials:
affiliation: Absenger Cancer Education Foundation, Spring Lake, Michigan & Saybrook University's College of Mind-Body Medicine, San Francisco, California
name: Werner Absenger, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: