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

July 1, 2019 updated by: Absenger Cancer Education Foundation

Quality of Life Outcomes Following Mind-body Skills Training for Cancer Patients That Are Facilitated Either Face-to-face or Online: A Pilot Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Spring Lake, Michigan, United States, 49456
        • Absenger Cancer Education Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Face-to-Face MBM Skills Group
Behavioral: 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.
Experimental: Online MBM Skills Group
Behavioral: 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.
Other: 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.
Other: Waitlist Control I
No intervention offered during study period. Intervention is offered after completion of study.
Other: Waitlisted Control II
This group will be given the option to participate in an Online MBM skills group intervention after conclusion of study.
Other: Waitlist Control II
No intervention offered during study period. Intervention is offered after completion of study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality Of Life, as assessed by the World Health Organization Quality of Life (WHOQOL-BREF) instrument
Time Frame: Baseline, week 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in distress, anxiety, depression and need for help as assessed by the Emotion Thermometers Tool© (ET5)
Time Frame: Baseline, Week 4
The ET5 is a five dimensional tool comprised of five visual-analogue scales in the form of four predictor domains (distress, anxiety, depression, anger) and one outcome domain (need for help). It is modeled after the original Distress Thermometer (DT) recommended by the US National Comprehensive Cancer Network. In order to detect broadly defined distress or anxiety, a combination of thermometers was most accurate (Mitchell, Baker-Glenn, Park, Granger, & Symonds, 2010). The ET5 tool expands on the DT by combining domains in order to detect emotional complications after a diagnosis with cancer.
Baseline, Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Absenger Cancer Education Foundation

Investigators

  • Principal Investigator: Werner Absenger, M.Sc., Absenger Cancer Education Foundation, Spring Lake, Michigan & Saybrook University's College of Mind-Body Medicine, San Francisco, California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MBM 5538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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