Objec'ves. Ra'onale and history for family based interven'ons Results from two family-based interven'ons - DAMES - Healthy Moves

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1 WORKING EVERYDAY TO PROVIDE THE HIGHEST QUALITY OF LIFE FOR PEOPLE WITH CANCER Taking on primary and terary cancer prevenon simultaneously through family-based intervenons: What works and what doesn t? WENDY DEMARK-WAHNEFRIED, PHD, RD PROFESSOR AND WEBB CHAIR OF NUTRITION SCIENCES ASSOCIATE DIRECTOR OF CANCER PREVENTION & CONTROL UNIVERSITY OF ALABAMA AT BIRMINGHAM Objec'ves Ra'onale and history for family based interven'ons Results from two family-based interven'ons - DAMES - Healthy Moves History of Effecve Home-based Diet and Exercise Intervenons FRESH START 543 Newly Dx ed Breast & Prostate Cancer Survivors Mailed Materials over 2 M Significant h F&V and PA, idietary Fat and Weight Effects on F&V and PA durable at 2-year follow-up MSSE 35: 45-24, 23; JCO 25:279-9, 27; J Acad Nutr Diet :844-5,2; Supp Care Cancer 2:2483-9,22; PsychoOncol 22:876-85,23 Reach-Out to EnhancE Wellness (RENEW) in Older, Long-term Survivors 64 Obese Breast, Prostate & Colon Cancer Survivors Mailed Materials/Telephone Counseling over 2M Significant iweight,h Diet Quality, h PA, h Physical Function Weight and Behavioral Change Durable at 2-year follow-up JAMA 3: 883-9, 29; JCO 3:2354-6,22 Commonali'es Across Interven'ons Behavioral Framework provided by Social Cogni've Theory with message framing using the Transtheore'cal Model Tailoring backed by a computer-based message library of thousands of messages and hundreds of illustra'ons. Variables: age cancer-type weight cancer coping style gender waist circumference race/ethnicity current health prac'ces (minutes of PA, intake of F&Vs, calories, dietary fat and its sources), barriers, readiness and selfefficacy to pursue lifestyle change and adherence to self-monitoring. Recruitment via referral & cancer registries Excellent reach Why a Family-Based Interven'on? Behavioral change may be more auainable if address at mul'ple levels Survivors and family members likely to share: - gene'c risk factors - environmental risk factors Address primary and ter'ary preven'on simultaneously

2 Review of Family-based Interven'ons 99 reports dyad (spouse, child, caregiver) x interven'on x trial Topics: psychosocial support, contracep'on, to diet and physical ac'vity On topic of diet and physical ac'vity <3 reports of diet and <2 on physical ac'vity interven'ons In cancer survivors < dyadic interven'ons, <3 in diet and physical ac'vity Obesity associated with poorer outcomes among women with breast cancer Obesity associated with increased risk of breast cancer occurring in later life Can we capitalize on the teachable moment of cancer and the motherdaughter bond to promote weight loss in overweight mothers with breast cancer and their overweight daughters as a means of terary AND primary prevenon? - AND is it best to use team or individually based tailoring? - AND how can you do it when pilot data show mothers and daughters live 354 miles apart? Daughters And MothErS (DAMES) Against Breast Cancer (R2-2243) Feasibility Trial to promote weight loss in overweight or obese breast cancer patients and their overweight or obese adult daughters Enroll 67 Mother-Daughter Dyads within 2-years? Retain at least 8% of participants? Safe? (no serious adverse events attributable to intervention) Assess weight loss (effect size and variance) in 3 arms: ) Standardized Materials 2) Tailored Materials (Independent Approach) 3) Tailored Materials (-Based Approach) Eligibility Criteria MOTHERS Dx d w/dcis or Stage I-III breast cancer within past 5 yrs No evidence of progressive disease or 2 nd primaries Approved for contact by oncology care physician BMI: 25-4 English-speaking & wring Completed the 5 th grade Community dwelling in US, Guam or Puerto Rico No pre-exisng condion that precludes adherence to an unsupervised exercise intervenon, e.g., scheduled for knee/hip surgery, dx d w/unstable angina, heart aback or CHF within 6 M, untreated stage 3 HTN, paralysis. Exercise < 5 min/week Not currently enrolled in a weight loss program Have biological daughter age 2 or older DAUGHTERS Same as moms, but no dx of breast cancer 27 Self-Referrals 249 Cancer Registry Cases 236 Breast Cancer Cases Mailed Study Invitation 2244 Total Potential Contactable Pool Response Rate: 38.4% Accrual Rate: 3% 8 Attention Moms/ Daughter 39 Eligible Moms Ascertained Daughters Sent Study Invitation 85 Mother-Daughter Dyads Identified Sent Full Study Consent 9 Consents received after study closure 6 Lost interest 7 Mother-Daughter Dyads Consented 68 Dyads Randomized 25 ly Tailored 2 Moms/2 Daughters 6M Follow-Up Assessments (59 Dyads) 2M Follow-Up Assessments (63 Dyads) 2 MD Denies Contact 56 Unusable address; 6 Deceased 25 Tailored 2 Moms/ Daughters 383 No response 36 No eligible daughter 28 Not interested 9 BMI <25 46 Medical Exclusions 32 Exercise >5 min/week 4 BMI >4 2 Enrolled in wt loss program 4 Non-English speakers 5 No response 23 Not interested 3 Medical Exclusions 6 Exercise >5 min/week BMI<25 3 BMI >4 3 Enrolled in wt loss program 2 Dyads Incomplete Baseline Assessment Attrition:.3% Tailored Interven'on Materials

3 Tailoring Experimental Arm Tailored using data from baseline survey and updates from interim surveys Accountability and selfmonitoring very IMPORTANT! Baseline Telephone Survey Tailored Workbook Mailed Survey Repeat 4x Tailored Newsletter Examples of tailored messages Mothers Daughters Age (x, sd, range) 6.3(7.4)(46-8) 32.9(.4)(2-54) BMI (x, sd) 3.(2.6) 32.9(.4) Race (%) Characteristics of the Study Sample White Hispanic Black Asian 74% 7% 8% % Current Smoker 2.9% 3.2% Income <$4K/year (%) 3% 28% Cancer Stage (%) 8% I 43% II 3% III 4% missing 4% Months from diagnosis 24 (3) (2 6) Miles Apart 75 (86) (-646) Measures/Measurement Points Baseline Every 7 wks 6 M Every 7 wks 2 M Process Data Weight Status (BMI) self-report & actual Blood Pressure Physical Activity Self-report, accelerometers V 2peak Day Dietary Recalls Quality of Life Self-Efficacy/Readiness / /-/-/ / /-/-/ / Perceived Risk of CA Social Support Adult Attachment Demographics DAMES: Loss in Body Weight (kg) -2 Months P=.4 Demark-Wahnefried et al. CANCER 2: , 24 Test for Dyad P=.9 DAMES: Reduc'on in Waist Circumference(cm) -2 Months P=.4 P=.3 P=.2 Demark-Wahnefried et al. CANCER 2: , 24 P=. Test for Dyad P=.2 P=.8

4 DAMES: Adherence to Assessment Surveys P-values by Randomiza'on Status (.9) by Mothers vs Daughters (.342) DAMES: Baseline to 2M Increases in Moderate- Vigorous Physical Ac'vity (min/week) DAMES: Baseline to 2M Changes in Caloric Intake no significant differences P= P= % of sample min week kcal day Demark-Wahnefried et al. CANCER 2: , 24 Demark-Wahnefried et al. CANCER 2: , 24 Demark-Wahnefried et al. CANCER 2: , 24 % of sample DAMES: Baseline to 2M Changes in Quality of Life Physical QoL no differences Demark-Wahnefried et al. CANCER 2: , 24 Mental QoL Daughter lost pounds Losing Weight is a Family Affair Mom lost 23 pounds Dog Rocky lost pounds DAMES: Overall Conclusions Interven'on is safe Reten'on is excellent Target enrollment met, but considerable barriers Adherence fair No systema'c changes observed in QoL and blood pressure All arms lost weight and increased physical ac'vity and diet quality, but effects more pronounced with tailored programs surprisingly more differences observed with individual vs. team interven'on

5 Healthy Moves: Raonale Theorecal Model Aims The rela'onship between survivors and spouses may be very different than mothers and daughters Spouses tend to live in the same household poten'al for enhanced social support Couples-Based print + counseling Interpersonal strategies - communal coping - joint problem - solving - communication Intrapersonal strategies - goal setting - self - monitoring - portion control Survivor Only print + counseling Intrapersonal strategies - goal setting - self - monitoring - portion control Spouse Factors - self - efficacy - social support Survivor Factors - self - efficacy - social support Spouse Outcomes - diet quality - physical activity - body weight Survivor Outcomes - diet quality - physical activity - body weight Secondary Outcomes - physical functioning - body composition - QOL Secondary Outcomes - physical functioning - body composition - QOL Primary Aims:. Modify an exis'ng mul'-behavior lifestyle interven'on for couples. 2. Pilot test the couples-based interven'on compared to a survivor only interven'on to explore feasibility and es'mate the effects on primary outcomes of survivor DQ and PA to provide effect sizes for a larger trial. Secondary Aims:. Explore the effects on survivors physical func'oning, body composi'on, QOL, and marital quality, as well as interven'on mediators including social support and self-efficacy. 2. Explore the effects on the interven'ons on spouse health behaviors, physical func'oning, body composi'on, QOL, and marital quality, as well as interven'on mediators. Diagnosis of loco-regional breast (Stages -IIIA), prostate (Stages I-II) or CRC (Stages I-II) Comple'on of primary treatment Prac'ce of one of two poor health behaviors (< 5 minutes of moderate or < 6 minutes of vigorous PA, and/or <7 F&V/day for women or <9 F&V/day for men) 8 years or older Read and speak English Reside in Houston area Eligibility Have a spouse/significant other with whom they have resided for at least one year Intervenons Randomized to Survivor Only or Couples-Based interven'on 9 counseling sessions delivered via webcamera Provided a workbook, pedometer, por'on plate, Therabands, and a fat gram counter Interven'ons lasted 6 months 5 minutes of strength exercise every other day 3 minutes moderate-intensity PA >5 days/ week > 7 F&V/day for women or >9/day for men Less than 7% of total calories from saturated fat Weight loss of -2 lbs/week for those with BMI>25 Measures Physical Ac'vity Godin Leisure Time Exercise Ques'onnaire; accelerometer Diet Automated Self-administered 24-hour Dietary Recall (ASA24) Performance Tests of Physical Func'oning Anthropometrics Height, weight, waist and hip circumference Health-Related Quality of Life Rand-36 Dual-energy -ray Absorp'ometry (DA) first 6 par'cipants only Social Cogni've Theory mediators Self-efficacy, social support

6 Refused (N=3) Not interested 59 Survivor/spouse ill 4 Time 3 Interested/unreachable No consent 5 Too far 2 Withdrew Work Couples-Based (N=2) 4-week mailed survey (N=9 6-month couples) assessment (N= couples) Recruitment Approach ed (N=5) Consente d (N=22) Baseline (N=22) Enrollment 4.6% Survivor Only (N=) Ineligible (N=26) Wrong diagnosis 2 Health 4 No spouse 4 Residence location No poor health behavior Spouse too healthy Spouse unable No computer 4-week mailed survey (N=6-month survivors; 9 assessment spouses) Demographics Survivor Spouse Age 63.9 (.4) (7.) Married % Female 59.% 4.9% Cancer Diagnosis Breast Prostate Colorectal Race/Ethnicity Caucasian African American Hispanic Other 59.% 36.4% 4.5% 7.4% 9.5% 4.3% 4.8% Educaon (> college grad) 64.% Employed full or part me 4.9% 77.8% 5.6% 6.6%.% Baseline Characteriscs Survivor Spouse Body Mass Index (6.42) (5.8) % Fat Total (DA) 37.6 (9.44) (9.2) % Android Fat (DA) 38.3 (4.63) 4.94 (7.6) Fruit & Vegetables (average per day) 2.57 (.25) 2.58 (.34) PA (min of moderate & strenuous) (36.5) (9.47) % meeng PA recommendaons 33.3% 23.8% Physical Component Score 47.9 (.4) (.38) Mental Component Score 53.9 (2.57) 56. (4.94) Process Data Survivor Couple-based Survivor Only Spouse Retenon (6 months) 92% % 92% Abendance (9 sessions) 93% 97% 9% Difficulty in using web-cam (=extremely; 5=not at all) Like using web-cam from home (=not at all; 5=a lot) Length of sessions (=too short; 5=too long) Counselor Effecveness (=not at all; 5=extremely) Recommend program to others Yes Maybe No 3.7 (.6) 2.3 (.5) 3.3 (.9) 3.8 (.8) 3.9 (.6) 3.5 (.5) 3. (.) 3. (.4) 2.8 (.4) 4.5 (.5) 4.6 (.8) 4.2 (.3) 83.3%.% 6.7% 66.7% 33.3%.%.%.%.% Survivor Outcomes Couples-Based Δ p Survivor Only Δ p Body Mass Index -.4 (.) (.88).2 Weight (kg) -3.3 (3.7) (2.5).2 Waist Circumference (4.8) (2.8).2 % Fat Total (DEA) -.5 (2.4) (.5).2 % Android Fat (DEA) (5.) (2.9).3 Fruit & Vegetables (average per day).77 (.9) <..96 (.9).2 Fiber Consumpon 6.56 (7.9) (.).26 Saturated Fat (8.3) ( 9.).59 PA (min of moderate & strenuous).4 (6.5) (34.3).92 Physical Component Score.67 (.5) ( Mental Component Score 3.55 (4.8) ( Spouse Outcomes Couples-based Δ p Survivor Only Δ p Body Mass Index -.29 (.8).4.6 (.7).56 Weight (4.6).3.33 (2.2).68 Waist Circumference (.) (3.3).77 % Fat Total (DEA) -.85 (2.7).9.26 (.3).46 % Android Fat (DEA) -3. (3.5) (2.4).67 Fruit & Vegetables (average per day).9 (.)..23 (.2).62 Fiber Consumpon 3.72 (5.2) (8.).89 Saturated Fat (5.7) (2.4).42 PA (min of moderate & strenuous) 65.5 (6.5) (23.8).77 Physical Component Score 5.86 (8.9).5.64 (4.).64 Mental Component Score (2.6) (.5).5

7 Healthy Moves: Conclusions The pilot study met feasibility benchmarks. Results demonstrate efficacy for survivors. High concordance in spousal health behaviors but no changes in spouses when only the survivor is targeted. Results highlight the necessity for including the spouse, which may be important for longterm behavior change. Overall: Conclusions Tailored interven'ons hold par'cular promise in promo'ng lifestyle change Dyad-based interven'ons also hold par'cular promise and benefit both survivor and partner Uptake, adherence and effect may depend upon the composi'on of the dyad selec'on of the partner may be best ler to the survivor Thank-you! Quesons? DAMES R2-CA92468 Lee Jones, PhD Isaac Lipkus, PhD Hoda Badr, PhD Gretchen Kimmick, MD Richard Sloane, MPH Denise Snyder, MS, RD, CSO Paige Miller, PhD, RD Stephanie Barrera, MS, RD Daniel Hughes, PhD Healthy Moves MD Anderson s Multi-Disciplinary Research Program Cindy Carmack, PhD Karen Basen-Engquist, PhD Laura Shely, MA George Baum, MA Sharon Giordano, MD Miguel Rodriguez-Bigas, MD Curtis Pettaway, MD Thanks to all survivors who participated in this research!