The Promoting Activity in Cancer Survivors (PACES) trial: a multiphase optimization of strategy approach to increasing physical activity in breast cancer survivors

Chad D Rethorst, Heidi A Hamann, Thomas J Carmody, Kendall J Sharp, Keith E Argenbright, Barbara B Haley, Celette Sugg Skinner, Madhukar H Trivedi, Chad D Rethorst, Heidi A Hamann, Thomas J Carmody, Kendall J Sharp, Keith E Argenbright, Barbara B Haley, Celette Sugg Skinner, Madhukar H Trivedi

Abstract

Background: Despite the significant, empirically supported benefits of physical activity, the majority of breast cancer survivors do not meet recommended guidelines for physical activity. A variety of effective strategies to increase physical activity in breast cancer survivors have been identified. However, it is unknown which of these strategies is most effective or how these strategies might be combined to optimize intervention effectiveness.

Methods: The proposed trial uses multiphase optimization strategy (MOST) to evaluate four evidence-based intervention strategies for increasing physical activity in breast cancer survivors. We will enroll 500 breast cancer survivors, age 18 and older, who are 3-months to 5 years post-treatment. Using a full-factorial design, participants will be randomized to receive a combination: 1) supervised exercise, 2) facility access, 3) self-monitoring, and 4) group-based active living counseling. The primary outcome, moderate-to-vigorous physical activity (MVPA) will be measured at baseline, 3 months, and 6 months using an Actigraph GT3X+. To evaluate intervention effects, a linear mixed-effects model will be conducted with MVPA as the outcome and with time (3 months and 6 months) as the within-subjects factor and intervention (i.e., supervised exercise, facility access, self-monitoring, and active living counseling) as the between subjects factor, along with all two-way interactions.

Discussion: The purpose of the PACES study is to evaluate multiple strategies for increasing physical activity in breast cancer survivors. Results of this study will provide in an optimized intervention for increasing physical activity in breast cancer survivors.

Trial registration: Clinicaltrials.gov Identifier: NCT03060941 . Registered February 23, 2017.

Conflict of interest statement

Ethics approval and consent to participate

Study approved by UT Southwestern IRB (FWA00005087). Written informed consent will be obtained from all study participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
Estimated participant recruitment

References

    1. Brewster AM, Hortobagyi GN, Broglio KR, et al. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst. 2008;100(16):1179–1183. doi: 10.1093/jnci/djn233.
    1. Del Chiaro M. Cancer risks in BRCA2 mutation carriers. J Natl Cancer Inst. 1999;91:1310–1316. doi: 10.1093/jnci/91.15.1310.
    1. Burstein HJ, Winer EP. Primary care for survivors of breast cancer. N Engl J Med. 2000;343(15):1086–1094. doi: 10.1056/NEJM200010123431506.
    1. Helgeson VS, Snyder P, Seltman H. Psychological and physical adjustment to breast cancer over 4 years: identifying distinct trajectories of change. Health Psychol. 2004;23(1):3–15. doi: 10.1037/0278-6133.23.1.3.
    1. Weaver KE, Forsythe LP, Reeve BB, et al. Mental and physical health-related quality of life among US Cancer survivors: population estimates from the 2010 National Health Interview Survey. Cancer Epidemiol Biomark Prev. 2012;21(11):2108–2117. doi: 10.1158/1055-9965.EPI-12-0740.
    1. Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005;330(7493):702. doi: 10.1136/bmj.38343.670868.D3.
    1. Watson M, Homewood J, Haviland J, Bliss JM. Influence of psychological response on breast cancer survival: 10-year follow-up of a population-based cohort. Eur J Cancer. 2005;41(12):1710–1714. doi: 10.1016/j.ejca.2005.01.012.
    1. Irwin ML, McTiernan A, Manson JE, et al. Physical activity and survival in postmenopausal women with breast cancer: results from the women's health initiative. Cancer Prev. Res (Phila) 2011;4(4):522–529.
    1. Irwin ML, Smith AW, McTiernan A, et al. Influence of pre- and postdiagnosis physical activity on mortality in breast cancer survivors: the health, eating, activity, and lifestyle study. J Clin Oncol. 2008;26(24):3958–3964. doi: 10.1200/JCO.2007.15.9822.
    1. Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005;293(20):2479–2486. doi: 10.1001/jama.293.20.2479.
    1. Chen X, Lu W, Zheng W, et al. Exercise after diagnosis of breast cancer in association with survival. Cancer Prev Res (Phila) 2011;4(9):1409–1418. doi: 10.1158/1940-6207.CAPR-10-0355.
    1. Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011;28(3):753–765. doi: 10.1007/s12032-010-9536-x.
    1. Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010;4(2):87–100. doi: 10.1007/s11764-009-0110-5.
    1. Schmitz KH, Courneya KS, Matthews C, et al. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010;42(7):1409–1426. doi: 10.1249/MSS.0b013e3181e0c112.
    1. Sternfeld B, Weltzien E, Quesenberry CP, Jr, et al. Physical activity and risk of recurrence and mortality in breast cancer survivors: findings from the LACE study. Cancer Epidemiol Biomark Prev. 2009;18(1):87–95. doi: 10.1158/1055-9965.EPI-08-0595.
    1. Holick CN, Newcomb PA, Trentham-Dietz A, et al. Physical activity and survival after diagnosis of invasive breast cancer. Cancer Epidemiol Biomark Prev. 2008;17(2):379–386. doi: 10.1158/1055-9965.EPI-07-0771.
    1. Karvinen KH, Carr LJ, Stevinson C. Resources for physical activity in cancer centers in the United States. Clin J Oncol Nurs. 2013;17(6):E71–E76. doi: 10.1188/13.CJON.E71-E76.
    1. Karvinen KH, DuBose KD, Carney B, Allison RR. Promotion of physical activity among oncologists in the United States. J Support Oncol. 2010;8(1):35–41.
    1. Daley AJ, Bowden SJ, Rea DW, Billingham L, Carmicheal AR. What advice are oncologists and surgeons in the United Kingdom giving to breast cancer patients about physical activity? Int J Behav Nutr Phys Act. 2008;5:46. doi: 10.1186/1479-5868-5-46.
    1. Hamann HA, Tiro JA, Sanders JM, et al. Validity of self-reported genetic counseling and genetic testing use among breast cancer survivors. J Cancer Surviv. 2013;7(4):624–629. doi: 10.1007/s11764-013-0301-y.
    1. Adams R. Revised Physical Activity Readiness Questionnaire. Can Fam Physician. 1999;45:992-1005.
    1. Vallance JK, Courneya KS, Plotnikoff RC, Yasui Y, Mackey JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007;25(17):2352–2359. doi: 10.1200/JCO.2006.07.9988.
    1. Vallance JK, Courneya KS, Taylor LM, Plotnikoff RC, Mackey JR. Development and evaluation of a theory-based physical activity guidebook for breast cancer survivors. Health Educ Behav. 2008;35(2):174–189. doi: 10.1177/1090198106287693.
    1. Rogers LQ, Courneya KS, Anton PM, et al. Effects of the BEAT Cancer physical activity behavior change intervention on physical activity, aerobic fitness, and quality of life in breast cancer survivors: a multicenter randomized controlled trial. Breast Cancer Res Treat. 2015;149(1):109–119. doi: 10.1007/s10549-014-3216-z.
    1. Sallis JF, Hovell MF, Hofstetter CR, et al. Distance between homes and exercise facilities related to frequency of exercise among san-Diego residents. Public Health Rep. 1990;105(2):179–185.
    1. Nelson MC, Gordon-Larsen P. Physical activity and sedentary behavior patterns are associated with selected adolescent health risk behaviors. Pediatrics. 2006;117(4):1281–1290. doi: 10.1542/peds.2005-1692.
    1. Buman MP, Giacobbi PR, Jr, Dzierzewski JM, et al. Peer volunteers improve long-term maintenance of physical activity with older adults: a randomized controlled trial. J Phys Act Health. 2011;8 Suppl 2:S257–S266. doi: 10.1123/jpah.8.s2.s257.
    1. Aittasalo M, Miilunpalo S, Kukkonen-Harjula K, Pasanen M. A randomized intervention of physical activity promotion and patient self-monitoring in primary health care. Prev Med. 2006;42(1):40–46. doi: 10.1016/j.ypmed.2005.10.003.
    1. Conroy MB, Yang K, Elci OU, et al. Physical activity self-monitoring and weight loss: 6-month results of the SMART trial. Med Sci Sports Exerc. 2011;43(8):1568–1574. doi: 10.1249/MSS.0b013e31820b9395.
    1. Dunn AL, Garcia ME, Marcus BH, Kampert JB, Kohl HW, Blair SN. Six-month physical activity and fitness changes in project active, a randomized trial. Med Sci Sports Exerc. 1998;30(7):1076–1083. doi: 10.1097/00005768-199807000-00009.
    1. Dunn AL, Marcus BH, Carpenter RA, Jaret P. Active living every day: Human Kinetics; 2010.
    1. Dunn AL, Marcus BH, Kampert JB, Garcia ME, Kohl HW, 3rd, Blair SN. Comparison of lifestyle and structured interventions to increase physical activity and cardiorespiratory fitness: a randomized trial. JAMA. 1999;281(4):327–334. doi: 10.1001/jama.281.4.327.
    1. Welk GJ, Blair SN, Wood K, Jones S, Thompson RW. A comparative evaluation of three accelerometry-based physical activity monitors. Med Sci Sports Exerc. 2000;32(9 Suppl):S489–S497. doi: 10.1097/00005768-200009001-00008.
    1. Coleman KJ, Ngor E, Reynolds K, et al. Initial validation of an exercise “vital sign” in electronic medical records. Med Sci Sports Exerc. 2012;44(11):2071–2076. doi: 10.1249/MSS.0b013e3182630ec1.
    1. Trivedi MH, Rush AJ, Ibrahim HM, et al. The inventory of depressive symptomatology, clinician rating (IDS-C) and self-report (IDS-SR), and the quick inventory of depressive symptomatology, clinician rating (QIDS-C) and self-report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol Med. 2004;34(01):73–82. doi: 10.1017/S0033291703001107.
    1. Rush AJ, Trivedi MH, Ibrahim HM, et al. The 16-item quick inventory of depressive symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003;54(5):573–583. doi: 10.1016/S0006-3223(02)01866-8.
    1. Rush AJ, Carmody TJ, Reimitz PE. The inventory of depressive symptomatology (IDS): clinician (IDS C) and self report (IDS SR) ratings of depressive symptoms. Int J Methods Psychiatr Res. 2000;9(2):45–59. doi: 10.1002/mpr.79.
    1. Buysse DJ, Reynolds CF, III, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh sleep quality index in primary insomnia. J Psychosom Res. 2002;53(3):737–740. doi: 10.1016/S0022-3999(02)00330-6.
    1. Mendoza TR, Wang XS, Cleeland CS, et al. The rapid assessment of fatigue severity in cancer patients: use of the brief fatigue inventory. Cancer. 1999;85(5):1186–1196. doi: 10.1002/(SICI)1097-0142(19990301)85:5<1186::AID-CNCR24>;2-N.
    1. Brady MJ, Cella DF, Mo F, et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J Clin Oncol. 1997;15(3):974–986. doi: 10.1200/JCO.1997.15.3.974.
    1. Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92–100. doi: 10.1207/s15327558ijbm0401_6.
    1. dela Cruz AM, Bernstein IH, Greer TL, et al. Self-rated measure of pain frequency, intensity, and burden: psychometric properties of a new instrument for the assessment of pain. J Psychiatr Res. 2014;59:155–160. doi: 10.1016/j.jpsychires.2014.08.003.
    1. Rizvi SJ, Quilty LC, Sproule BA, Cyriac A, Michael Bagby R, Kennedy SH. Development and validation of the dimensional anhedonia rating scale (DARS) in a community sample and individuals with major depression. Psychiatry Res. 2015;229(1–2):109–119. doi: 10.1016/j.psychres.2015.07.062.
    1. Funk J, Rogge R. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the couples satisfaction index. J Fam Psychol. 2007;21(4):572. doi: 10.1037/0893-3200.21.4.572.
    1. Marcus BH, Forsyth L. Motivating people to be physically active: Human Kinetics; 2003.
    1. Collins LM, Trail JB, Kugler KC, Baker TB, Piper ME, Mermelstein RJ. Evaluating individual intervention components: making decisions based on the results of a factorial screening experiment. Transl Behav Med. 2014;4(3):238–251. doi: 10.1007/s13142-013-0239-7.
    1. Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007;32(5 Suppl):S112–S118. doi: 10.1016/j.amepre.2007.01.022.
    1. Collins LM, Murphy SA, Nair VN, Strecher VJ. A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med. 2005;30(1):65–73. doi: 10.1207/s15324796abm3001_8.
    1. Dziak JJ, Nahum-Shani I, Collins LM. Multilevel factorial experiments for developing behavioral interventions: power, sample size, and resource considerations. Psychol Methods. 2012;17(2):153–175. doi: 10.1037/a0026972.
    1. Cohen J. Statistical power analysis for the behavioral sciences: Lawrence Erlbaum; 1988.

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