P05.18An Exploration of the Effects of Tibetan Yoga onPatient’s Quality of Life and Experience of Lymphoma:An Experimental Embedded Mixed Methods Study

Alejandro Chaoul (1), Isabel Leal (1), Joan Engebretson (2),Lorenzo Cohen (1)

(1) University of Texas, M.D. Anderson Cancer Center, Houston,TX, USA(2) University of Texas, School of Nursing, Houston, TX, USA

Purpose: To explore the effects of a Tibetan Yoga (TY) inter-vention on patient’s experience of lymphoma and quality of life(QOL) through a comparative analysis.Methods: Research Approach: An experimental embeddedmixed methods design. Participants: 16 lymphoma patients re-ceiving or having received treatment within the prior 12 months.Methods: Quantitative and qualitative data were collected con-currently from the same participants using various surveysevaluating social, physical, emotional, and spiritual domains andopen-ended narrative questions at four time periods: baseline,and 1-week, 1-month and 3-month post intervention. Qualitativedata consisted of written responses to 3 open-ended questionsfocusing on patient’s experiences of cancer. Results of the twodata sets were compared to elucidate findings and clarify con-gruent and divergent patterns in patient profiles. Qualitativefindings between participants in the TY and wait-list group werealso compared for salient differences.Results: Convergence, divergence and contradiction were foundin the comparison of the two data sets. The qualitative dataserved to explain, elucidate and expand upon some of the find-ings and discrepancies between the data sets and captured ex-periential effects beyond the pre-set measurements of thequantitative instruments. The theme of acceptance was signifi-cantly more prominent in participant’s narratives in the TY asopposed to control group.Conclusion: Comparing and integrating data and findings fromquantitative and qualitative methods in a mixed methods studyresulted in a more complete understanding of research questionsthan either approach alone, capturing experiential effectsmeaningful to patients and recognizing a more comprehensiverange of patient outcomes. Incorporating a qualitative compo-nent within this RCT grounded experimental research-basedresults within the real-world context of patient’s lives contrib-uting to research focused on translation, dissemination and im-plementation.Contact: Alejandro Chaoul, machaoul@mdanderson.org

P05.19Psychometric Analyses of the Arizona LifestyleInventory: A Multi-Dimensional Integrative MedicineMeasure to Assess Wellness Behaviors

Audrey Brooks (1), Sally Dodds (1), Paula Cook (1), VictoriaMaizes (1), Patricia Lebensohn (1)

(1) Arizona Center for Integrative Medicine/University ofArizona, Tucson, AZ, USA

Purpose: A measure of wellness-oriented behaviors reflectingthe whole person orientation of Integrative Medicine (IM) wasdeveloped. Initial psychometric analyses of the measure arepresented.

Methods: Residents and medical students (n = 276) completedthe Arizona Lifestyle Inventory (ALI). The ALI is a 77-itemscale assessing diet/supplements, exercise, mind-body, spiritu-ality, relationships, sleep, social/leisure activities, work, andbackground health status. Validated measures of well-being:burnout (emotional exhaustion, depersonalization), depression,positive and negative affect, perceived stress, life satisfaction,and multi-dimensional well-being ratings were also completed.Results: Psychometric analyses using Classical Test Theorytechniques confirmed scales for the following domains: diet/supplements, spirituality/mind-body, exercise/time outdoors,relationships, and sleep. Social/leisure activities and work itemsdid not form psychometrically sound scales. Convergent validityand divergent validity was assessed by correlating the ALI scalesto the multidimensional well-being scale. The diet and exercisescales were more strongly correlated with physical well-being;while spirituality/mind-body and relationship scales correlatedmore strongly with spiritual and social well-being respectively.Sleep correlated most strongly with mental well-being. Allscales correlated significantly with overall well-being in the pastmonth and at the present moment. Additionally, the sleep, re-lationship, and exercise scales correlated significantly with theburnout, depression, affect, perceived stress, and life satisfactionmeasures. The diet and spirituality/mind-body scales were sig-nificantly correlated to life satisfaction only. Several items notloading on scales correlated with the well-being measures. Workstress items correlated significantly with the well-being mea-sures; however work hours did not correlate with depersonal-ization, perceived stress, and physical and social well-being.Two social/leisure items (hobbies, belonging to organizedgroups) correlated significantly with most of the well-beingmeasures.Conclusion: Initial psychometric analyses confirmed the pri-mary wellness behavior domains. Future analyses on a largersample include Item Response Theory analyses to further vali-date these findings. A psychometrically sound wellness behaviorinventory for IM could be important for research and clinicalpurposes.Contact: Patricia Lebensohn, plebenso@email.arizona.edu

P05.20Obtaining an Investigational New Drug Number (IND)from the FDA for Research with a Fruit

Mike Cusnir (1), Richard Campbell (2), Heloisa Soares (3)

(1) Mount Sinai Comprehensive Cancer Center, Miami Beach,FL, USA(2) Fairchild Tropical Garden, Miami, FL, USA(3) University of California,Los Angeles, CA, USA

Purpose: As part of the research project to investigate the use ofSynsepalum Dulcificum (Miracle Fruit)for taste alterations inpatients undergoing chemotherapy, we decided, as it is cus-tomary in most oncology studies, to pursue an application withthe Food and Drug Administration for an Investigational NewDrug Number for the use of the whole fruit.Methods: All application materials and research protocolwere submitted to the FDA, explaining the intention to collectthe fruit from the Fairchild Botanical Garden and provide itfrozen to oncology patients having taste alterations secondary tochemotherapy. Patients were instructed to 10 to 15 minutes priorto meals put the whole fruit in their mouth and gently suck/chewit to remove the flesh from the seed. Then discard the seed.

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Afterwards they used a validated questionnaire to grade taste andquality of life. The study length was 7 weeks from enrollment.Results: The FDA required to submit the following aspects re-garding the fruit including: type of fertilizer used, pesticides,stage of maturation at which the fruit was collected, how it waswashed after collection, if dried or fresh frozen fruit was to beused, how fast it was frozen and at what temperature, how wemaintained the cold chain from the garden to the hospital andthen to the patients house, results of microbiology studies sincethere was the potential use by neutropenic patients, and how thestudy was planning to report the possible adverse events thatmight occur during the study.Conclusion: After complying with all these requirements, wewere granted the approval for research with IND number102148 on April of 2008. The study was completed in No-vember of 2011 after enrolling 48 patients and is in prepara-tion for publication.Contact: Mike Cusnir, mike.cusnir@msmc.com

P05.21Using the Nominal Group Technique to Identify the KeyMethodological Issues in Acupuncture Clinical Trials

Yutong Fei (1), Qianyun Chai (1), Chunxiao Yang (1), YingZhang (1), Jianping Liu (1)

(1) Center for Evidence-Based Chinese Medicine, University ofChinese Medicine, Beijing, China

Purpose: To identify the key methodological issues that mightinfluence the acupuncture treatment adequacy and introduce biasto the results when designing and implementing acupunctureclinical trials from the views of Chinese acupuncturists andmethodologists.Methods: Nominal group technique (NGT) as a structured groupdecision-making method was applied. Nine participants frommainland China and Hong Kong were invited, including six acu-puncturists, two acupuncture trialists and one methodologist. Anintroduction to the subjects for discussion was given at the be-ginning. When all the participants were clear with the subjects, 20minutes were given to them to write down their own thoughts.Then one by one, the participants presented their opinions. Then allthe opinions were discussed until consensus were made by voting.Results: All participants expressed their opinions. Four key is-sues on methodology were raised and consensus was achievedafter discussion. First, under different acupuncture clinicalpractice, five aspects were agreed: (1) different expertise andpracticing habits of acupuncturists; (2) insufficient training ac-cording to the research protocols; (3) insufficient acupuncturetreatment details described in the protocols (such as acupointnames and locations, needle insertion methods and direction,manipulation methods, sequence of acupoints stimulated in onetreatment, extent to which the treatment could be individual-ized); (4) deviation from protocols by the acupuncturists; and (5)alternatives of acupuncturists. Second, incompliance of theparticipants due to lack of confidence to acupuncture therapy andacupuncturists, use of sham acupuncture and inadequate acu-puncture treatments. Third, inappropriate set of sham control(lack of theoretical validity and practical validity). Forth, mul-tiple roles of personnel in acupuncture trials.Conclusion: Methodological issues around acupuncture trialswere identified from this study, and future guidelines for de-signing and managing of acupuncture trials should consider

these aspects. We suggest that some of the items of the CON-SORT statement and STRICTA could be referred when de-signing acupuncture trials.Contact: Yutong Fei, yutong_fei@163.com

P05.22Role of TCM for Cancer in China: A Semi-StructuredQualitative Interview of Cancer Patients, FamilyMembers and Oncologists

Xun Li (1), Zhijun Liu (1), Xinxue Li (1), Jianping Liu (1)

(1) Centre for Evidence-Based Chinese Medicine, BeijingUniversity of Chinese Medicine, Beijing, China

Purpose: Traditional Chinese Medicine (TCM) is widely usedfor cancer in China, and almost all the cancer patients would tosome degree receive TCM treatment. The reason and attitudetoward TCM in cancer field is unknown. This study aims toidentify the role of TCM for cancer treatment.Methods: Semi-structured qualitative interview was taken in in/out-patient sections of four integrative Chinese and Westernmedicine hospitals in China and thematic analysis was appliedResults: Totally 35 cancer patients, 9 family members, and 3TCM oncologists were interviewed. Four themes including 1)aim of TCM application, 2) people’s satisfaction, 3) under-standing and attitude and 4) believe and expectation towardTCM arose. TCM is applied in purpose of regulating the body,improving immunity, maintaining physical strength, and con-trolling the tumor. The satisfaction and compliance is highlycoordinated with the clinical effectiveness. TCM is believed tobe long-time intervention adjuvant to conventional treatment inholistic and softer way, which must be taken with or after thesurgery or chemoradiotherapy. People have deep trust in theeffectiveness of TCM for cancer, and its status and importance isirreplaceable. TCM and Western medicine are indispensable forcancer patients. Compared with Western medicine, althoughslower, TCM has indelible advantages and value, largelybringing hope to patients and their families. The intervieweesalso had great expectations for the further development andbreakthrough in the applications of TCM in improving quality oflife and controlling the tumor, the comprehensive inheriting andwider spread of real TCM expertise, as well as hospital admin-istration.Conclusion: TCM is considered playing the role adjuvant toconventional treatment, but is highly trusted by cancer patients,their family and oncologists as an indispensable part in cancerclinical applications in China. We suggest the effectiveness ofTCM be evaluated in further clinical studies.Contact: Jianping Liu, jianping_l@hotmail.com

P05.23Comparison of Integrative Health Therapies as Relatedto Pain and the Influence of Sleeping Patients as MissingData

Rachael Rivard (1), Kristen Haven (1), Jill Johnson (1), JeffDusek (1)

(1) Penny George Institute for Health and Healing, Minnea-polis, MN, USA

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