Quality of LifeNCT01586546

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

A study testing Face-to-Face MBM Skills Group and Online MBM Skills Group in people with Quality of Life and Life Change Events, run by Absenger Cancer Education Foundation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Quality of Life, Life Change Events, Neoplasms
What is being tested?: Face-to-Face MBM Skills Group and Online MBM Skills Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: May 2012to 1 Dec 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Absenger Cancer Education Foundation
Spring Lake, Michigan, 49456

Other trials in United States

About this study

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

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
Being tested: Face-to-Face MBM Skills Group, Waitlist Control I, Waitlist Control II, Online MBM Skills Group
Keywords: Mind-body, Psychosocial, Meditation, Breathing Exercises, Guided Imagery, Visualization
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Face-to-Face MBM Skills GroupBehavioural
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 IOther
No intervention offered during study period. Intervention is offered after completion of study.
Waitlist Control IIOther
No intervention offered during study period. Intervention is offered after completion of study.
Online MBM Skills GroupBehavioural
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.

Study groups in NCT01586546
Study group	Role	What they receive
Face-to-Face MBM Skills Group	Experimental	Not described Receives: Behavioral: Face-to-Face MBM Skills Group
Online MBM Skills Group	Experimental	Not described Receives: 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. Receives: 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. Receives: Other: Waitlist Control II

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline, week 4

Secondary outcomes (1)

Change in distress, anxiety, depression and need for help as assessed by the Emotion Thermometers Tool© (ET5)
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.
Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 20121 Dec 2012

First posted27 Apr 2012 (estimated)
Study startMay 2012
Primary completionDec 2012
Study completion1 Dec 2012

Why it stopped: Encountered significant recruitment challenges, and it was decided to terminate the study without recruiting participants.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Quality of LifeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01586546
Sponsor's protocol ID: MBM 5538
Status last verified: Jul 2019
First submitted: 23 Apr 2012
Last updated: 5 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01586546
Acronym / sponsor ID: MBM 5538
Conditions: Quality of Life, Life Change Events, Neoplasms
Keywords: Mind-body, Psychosocial, Meditation, Breathing Exercises, Guided Imagery, Visualization
Study type: Interventional
Recruitment status: TerminatedReason stopped: Encountered significant recruitment challenges, and it was decided to terminate the study without recruiting participants.
Enrolment: 32 participants (actual)
Lead sponsor: Absenger Cancer Education FoundationUniversity, hospital or other
Study start: May 2012
Primary completion: Dec 2012 (actual)
Study completion: 1 Dec 2012 (actual)
First posted: 27 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
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	Other: Waitlist Control IThis group will be given the option to participate in a face-to-face MBM skills group intervention after conclusion of study.
Waitlisted Control II	Other	Other: Waitlist Control IIThis group will be given the option to participate in an Online MBM skills group intervention after conclusion of study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Face-to-Face MBM Skills GroupMind 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.	Behavioural	Face-to-Face MBM Skills Group
Waitlist Control INo intervention offered during study period. Intervention is offered after completion of study.	Other	Waitlist Control I
Waitlist Control IINo intervention offered during study period. Intervention is offered after completion of study.	Other	Waitlisted Control II
Online MBM Skills GroupMind 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.	Behavioural	Online MBM Skills Group

Primary outcome

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).

1 secondary outcome

Change in distress, anxiety, depression and need for help as assessed by the Emotion Thermometers Tool© (ET5)
Time frame: Baseline, Week 4

Results and safety

The study was stopped early (reason given: Encountered significant recruitment challenges, and it was decided to terminate the study without recruiting participants.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Absenger Cancer Education Foundation HomepageLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Quality of Life

Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Active, not recruitingPhase 2
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Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
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Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Werner Absenger, M.Sc. principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality Of Life, as assessed by the World Health Organization Quality of Life (WHOQOL-BREF) instrument (time frame: Baseline, week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01586546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.