Use of Mental Health Apps by Breast Cancer Patients and Their Caregivers in the United States: Protocol for a Pilot Pre-Post Study

Philip I Chow, Shayna L Showalter, Matthew S Gerber, Erin Kennedy, David R Brenin, Anneke T Schroen, David C Mohr, Emily G Lattie, Wendy F Cohn, Philip I Chow, Shayna L Showalter, Matthew S Gerber, Erin Kennedy, David R Brenin, Anneke T Schroen, David C Mohr, Emily G Lattie, Wendy F Cohn

Abstract

Background: Over one-third of cancer patients experience clinically significant mental distress, and distress in caregivers can exceed that of the cancer patients for whom they care. There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones.

Objective: The aim of this study is to describe the protocol to pilot a mobile app-based mental health intervention in breast cancer patients and caregivers.

Methods: The IntelliCare mental health apps are grounded in evidence-based research in psychology. They have not been examined in cancer populations. This pilot study will adopt a within-subject, pre-post study design to inform a potential phase III randomized controlled trial. A target sample of 50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center. Consent will be obtained in writing and a mobile phone will be provided if needed. Self-report surveys assessing mental health outcomes will be administered at a baseline session and after a 7-week intervention. Before using the apps, participants will receive a 30-min coaching call to explain their purpose and function. A 10-min coaching call 3 weeks later will check on user progress and address questions or barriers to use. Self-report and semistructured interviews with participants at the end of the study period will focus on user experience and suggestions for improving the apps and coaching in future studies.

Results: This study is ongoing, and recruitment will be completed by the end of 2018.

Conclusions: Results from this study will inform how scalable mobile phone-delivered programs can be used to support breast cancer patients and their loved ones.

Trial registration: ClinicalTrials.gov NCT03488745; https://ichgcp.net/clinical-trials-registry/NCT03488745.

International registered report identifier (irrid): DERR1-10.2196/11452.

Keywords: cancer; caregivers; mHealth; mental health.

Conflict of interest statement

Conflicts of Interest: DCM has equity ownership in and EGL has received consulting fees from Actualize Therapy, a company developing and making available mobile technology products related to the research reported in this manuscript. DCM and EGL will not have direct access to the final raw dataset.

©Philip I Chow, Shayna L Showalter, Matthew S Gerber, Erin Kennedy, David R Brenin, Anneke T Schroen, David C Mohr, Emily G Lattie, Wendy F Cohn. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.01.2019.

Figures

Figure 1
Figure 1
Screenshots of the Thought Challenger app as seen on a mobile phone screen.

References

    1. . [2018-10-05]. U.S. Breast Cancer Statistics .
    1. Hegel MT, Moore CP, Collins ED, Kearing S, Gillock KL, Riggs RL, Clay KF, Ahles TA. Distress, psychiatric syndromes, and impairment of function in women with newly diagnosed breast cancer. Cancer. 2006 Dec 15;107(12):2924–31. doi: 10.1002/cncr.22335. doi: 10.1002/cncr.22335.
    1. Sklenarova H, Krümpelmann A, Haun MW, Friederich H, Huber J, Thomas M, Winkler EC, Herzog W, Hartmann M. When do we need to care about the caregiver? Supportive care needs, anxiety, and depression among informal caregivers of patients with cancer and cancer survivors. Cancer. 2015 May 01;121(9):1513–9. doi: 10.1002/cncr.29223. doi: 10.1002/cncr.29223.
    1. Grunfeld E, Coyle D, Whelan T, Clinch J, Reyno L, Earle CC, Willan A, Viola R, Coristine M, Janz T, Glossop R. Family caregiver burden: results of a longitudinal study of breast cancer patients and their principal caregivers. Can Med Assoc J. 2004 Jun 8;170(12):1795–801.
    1. Pirl WF, Fann JR, Greer JA, Braun I, Deshields T, Fulcher C, Harvey E, Holland J, Kennedy V, Lazenby M, Wagner L, Underhill M, Walker DK, Zabora J, Zebrack B, Bardwell WA. Recommendations for the implementation of distress screening programs in cancer centers: report from the American Psychosocial Oncology Society (APOS), Association of Oncology Social Work (AOSW), and Oncology Nursing Society (ONS) joint task force. Cancer. 2014 Oct 01;120(19):2946–54. doi: 10.1002/cncr.28750. doi: 10.1002/cncr.28750.
    1. Bender JL, Yue RY, To MJ, Deacken L, Jadad AR. A lot of action, but not in the right direction: systematic review and content analysis of smartphone applications for the prevention, detection, and management of cancer. J Med Internet Res. 2013;15(12):e287. doi: 10.2196/jmir.2661.
    1. Pew Research Center. Mobile Fact Sheet
    1. Donker T, Petrie K, Proudfoot J, Clarke J, Birch M, Christensen H. Smartphones for smarter delivery of mental health programs: a systematic review. J Med Internet Res. 2013;15(11):e247. doi: 10.2196/jmir.2791.
    1. Bakker D, Kazantzis N, Rickwood D, Rickard N. Mental health smartphone apps: review and evidence-based recommendations for future developments. JMIR Ment Health. 2016;3(1):e7. doi: 10.2196/mental.4984.
    1. Torous J, Roberts LW. Needed innovation in digital health and smartphone applications for mental health: transparency and trust. JAMA Psychiatry. 2017 May 01;74(5):437–438. doi: 10.1001/jamapsychiatry.2017.0262.
    1. Torous J, Luo J, Chan S. Mental health apps: what to tell patients: an evaluation model created specifically for such apps can help guide your discussions. Curr Psychiatry. 2018;17(3):21–25.
    1. Mani M, Kavanagh DJ, Hides L, Stoyanov SR. Review and evaluation of mindfulness-based iPhone apps. JMIR Mhealth Uhealth. 2015;3(3):e82. doi: 10.2196/mhealth.4328.
    1. Wilson H, Stoyanov SR, Gandabhai S, Baldwin A. The quality and accuracy of mobile apps to prevent driving after drinking alcohol. JMIR Mhealth Uhealth. 2016 Aug 08;4(3):e98. doi: 10.2196/mhealth.5961.
    1. Torous J, Nicholas J, Larsen ME, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health. 2018 Aug;21(3):116–119. doi: 10.1136/eb-2018-102891.
    1. Oulasvirta A, Tamminen S, Roto V, Kuorelahti J. Interaction in 4-second bursts: the fragmented nature of attentional resources in mobile HCI. Proceedings of the ACM SIGCHI conference on Human factors in computing systems; 2005; Oregon, USA. 2005. Apr 02, pp. 919–928.
    1. Schueller SM, Tomasino KN, Mohr DC. Integrating human support into behavioral intervention technologies: the efficiency model of support. Clin Psychol Sci Pract. 2016;24(1):27–45. doi: 10.1111/cpsp.12173.
    1. Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011;13(1):e30. doi: 10.2196/jmir.1602.
    1. Mohr DC, Tomasino KN, Lattie EG, Palac HL, Kwasny MJ, Weingardt K, Karr CJ, Kaiser SM, Rossom RC, Bardsley LR, Caccamo L, Stiles-Shields C, Schueller SM. IntelliCare: an eclectic, skills-based app suite for the treatment of depression and anxiety. J Med Internet Res. 2017 Jan 05;19(1):e10. doi: 10.2196/jmir.6645.
    1. Lattie EG, Schueller SM, Sargent E, Stiles-Shields C, Tomasino KN, Corden ME, Begale M, Karr CJ, Mohr DC. Uptake and usage of IntelliCare: a publicly available suite of mental health and well-being apps. Internet Interv. 2016 May;4(2):152–158. doi: 10.1016/j.invent.2016.06.003.
    1. Kroenke K, Spitzer R, Williams J. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606–13.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–7. doi: 10.1001/archinte.166.10.1092.
    1. Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework. PLoS One. 2016;11(3):e0150205. doi: 10.1371/journal.pone.0150205.
    1. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi: 10.1186/1471-2288-10-1.
    1. Benner A. Sample Size Tables For Clinical Studies. (2nd edn) Oxford, London, Berlin: Blackwell Science Ltd; 1999. Feb 28, pp. 494–495.
    1. Lane W, Manner C. The impact of personality traits on smartphone ownership and use. IJBSS. 2011;2(17):22–28.
    1. Xiong H, Huang Y, Barnes L, Gerber M. Sensus: a cross-platform, general-purpose system for mobile crowdsensing in human-subject studies. Proceedings of the ACM International Joint Conference on Pervasive and Ubiquitous Computing; 2016; Heidelberg, Germany. 2016. Sep 12,
    1. Chow PI, Fua K, Huang Y, Bonelli W, Xiong H, Barnes LE, Teachman BA. Using mobile sensing to test clinical models of depression, social anxiety, state affect, and social isolation among college students. J Med Internet Res. 2017 Mar 03;19(3):e62. doi: 10.2196/jmir.6820.
    1. Lund A. Measuring usability with the use questionnaire. Usability Interface. 2001;8(2):3–6.
    1. Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai J, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179–94. doi: 10.1016/j.jclinepi.2010.04.011.
    1. Kroenke K, Spitzer RL, Williams JB, Löwe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50(6):613–21. doi: 10.1176/appi.psy.50.6.613.
    1. Löwe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brähler E. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord. 2010 Apr;122(1-2):86–95. doi: 10.1016/j.jad.2009.06.019.
    1. Ugalde A, Krishnasamy M, Schofield P. Development of an instrument to measure self-efficacy in caregivers of people with advanced cancer. Psychooncology. 2013 Jun;22(6):1428–34. doi: 10.1002/pon.3160.
    1. Lenth RV. Some practical guidelines for effective sample size determination. Am Stat. 2001 Aug;55(3):187–193. doi: 10.1198/000313001317098149.
    1. Carlson LE, Bultz BD. Cancer distress screening: needs, models, and methods. J Psychosom Res. 2003 Nov;55(5):403–409. doi: 10.1016/S0022-3999(03)00514-2.
    1. Vanderwerker LC, Laff RE, Kadan-Lottick NS, McColl S, Prigerson HG. Psychiatric disorders and mental health service use among caregivers of advanced cancer patients. J Clin Oncol. 2005 Oct 01;23(28):6899–907. doi: 10.1200/JCO.2005.01.370.
    1. Kurtz ME, Kurtz JC, Given CW, Given B. A randomized, controlled trial of a patient/caregiver symptom control intervention: effects on depressive symptomatology of caregivers of cancer patients. J Pain Symptom Manage. 2005 Aug;30(2):112–22. doi: 10.1016/j.jpainsymman.2005.02.008.
    1. Gilbody S, Brabyn S, Lovell K, Kessler D, Devlin T, Smith L, Araya R, Barkham M, Bower P, Cooper C, Knowles S, Littlewood E, Richards DA, Tallon D, White D, Worthy G, REEACT collaborative Telephone-supported computerised cognitive-behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial. Br J Psychiatry. 2017 May;210(5):362–367. doi: 10.1192/bjp.bp.116.192435.
    1. Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288–95. doi: 10.1002/wps.20151. doi: 10.1002/wps.20151.
    1. Neary M, Schueller SM. State of the field of mental health apps. Cogn Behav Pract. 2018 Mar;25(4):531–37. doi: 10.1016/j.cbpra.2018.01.002.
    1. Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484–9. doi: 10.1001/archpsyc.63.5.484.
    1. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626–9. doi: 10.1016/j.jpsychires.2010.10.008.

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