TerminatedNot Applicable

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

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

United States32 participantsStarted 2012-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, week 4

Trial details

NCT IDNCT01586546

SponsorAbsenger Cancer Education Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

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