Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study

Catherine Benedict, Jennifer S Ford, Lidia Schapira, Pamela Simon, David Spiegel, Michael Diefenbach, Catherine Benedict, Jennifer S Ford, Lidia Schapira, Pamela Simon, David Spiegel, Michael Diefenbach

Abstract

Introduction: Many young adult female (YA-F) cancer survivors who received gonadotoxic therapy will experience fertility problems. After cancer, having a child will often require assisted reproductive technology (ART), surrogacy or adoption. However, there are significant informational, psychosocial, financial and logistical barriers to pursuing these options. Survivors report high rates of decision uncertainty and distress related to family-building decisions. The aim of this study is to pilot test a web-based decision aid and planning tool for family-building after cancer.

Methods and analysis: The pilot study will use a single-arm trial design to test the feasibility and acceptability (aim 1) and obtain effect size estimates of the decision support intervention (aim 2). The target sample size is 100. Participants will include YA-F survivors (aged 18-45 years) who are post-treatment and have not completed desired family-building. A longitudinal prepost design will be conducted. Participants will complete three psychosocial assessment surveys over a 3-month time period to track decisional conflict (primary outcome) and cognitive, emotional, and behavioural functioning (secondary outcomes). After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website. Postintervention surveys will be administered at 1-month (T2) and 3-month (T3) follow-up time points. Feasibility and acceptability metrics will be analysed. Pairwise t-tests will test mean scores of outcome variables from T1 to T2. Effect size estimates (Cohen's d) will be calculated. Google analytics will evaluate user engagement with the website over the study period. Baseline and follow-up data will examine measures of feasibility, acceptability and intervention effect size.

Ethics and dissemination: This will be the first test of a supportive intervention to guide YA-F cancer survivors in family-building decisions and early planning. Study findings will inform intervention development. Future directions will include a randomised controlled trial to test intervention efficacy over a longer time period.

Trial registration number: NCT04059237; Pre-results.

Keywords: adult oncology; cancer support intervention; decision aids; decision-making; eHealth; fertility.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design and participant flow. A longitudinal prepost intervention design will be conducted in which participants (n=100) complete three survey questionnaires at baseline (T1; pre-intervention) and at 1-month (T2) and 3-month (T3) follow-up time points (postintervention).

References

    1. Coccia PF, Pappo AS, Beaupin L, et al. . Adolescent and young adult oncology, version 2.2018, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 2018;16:66–97. 10.6004/jnccn.2018.0001
    1. Keegan THM, Ries LAG, Barr RD, et al. . Comparison of cancer survival trends in the United States of adolescents and young adults with those in children and older adults. Cancer 2016;122:1009–16. 10.1002/cncr.29869
    1. Lewin J, Ma JMZ, Mitchell L, et al. . The positive effect of a dedicated adolescent and young adult fertility program on the rates of documentation of therapy-associated infertility risk and fertility preservation options. Support Care Cancer 2017;25:1915–22. 10.1007/s00520-017-3597-8
    1. Irene Su H, Lee YT, Barr R. Oncofertility: meeting the fertility goals of adolescents and young adults with cancer. Cancer J 2018;24:328–35. 10.1097/PPO.0000000000000344
    1. Kim J, Mersereau JE, Su HI, et al. . Young female cancer survivors’ use of fertility care after completing cancer treatment. Support Care Cancer 2016;27:3191–9. 10.1007/s00520-016-3138-x
    1. Geue K, Richter D, Schmidt R, et al. . The desire for children and fertility issues among young German cancer survivors. J Adolesc Health 2014;54:527–35. 10.1016/j.jadohealth.2013.10.005
    1. Benedict C, Thom B, N. Friedman D, et al. . Young adult female cancer survivors' unmet information needs and reproductive concerns contribute to decisional conflict regarding posttreatment fertility preservation. Cancer 2016;122:2101–9. 10.1002/cncr.29917
    1. Benedict C, Shuk E, Ford JS. Fertility issues in adolescent and young adult cancer survivors. J Adolesc Young Adult Oncol 2016;5:48–57. 10.1089/jayao.2015.0024
    1. Ehrbar V, Urech C, Tschudin S. Fertility decision-making in cancer patients – current status and future directions. Expert Rev Qual Life Cancer Care 2018;3:113–9. 10.1080/23809000.2018.1503539
    1. Woodard TL, Hoffman AS, Covarrubias LA, et al. . The pathways fertility preservation decision aid website for women with cancer: development and field testing. J Cancer Surviv 2018;12:101–14. 10.1007/s11764-017-0649-5
    1. Stark SS, Natarajan L, Chingos D, et al. . Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors. Contemp Clin Trials 2019;77:27–36. 10.1016/j.cct.2018.12.002
    1. Bradford A, Woodard TL. Novel psychological intervention for decision support in women considering fertility preservation before cancer treatment. J Adolesc Young Adult Oncol 2017;6:348–52. 10.1089/jayao.2016.0066
    1. Wang Y, Anazodo A, Logan S. Systematic review of fertility preservation patient decision AIDS for cancer patients. Psychooncology 2019;28:459–67. 10.1002/pon.4961
    1. Logan S, Perz J, Ussher JM, et al. . A systematic review of patient oncofertility support needs in reproductive cancer patients aged 14 to 45 years of age. Psychooncology 2018;27:401–9. 10.1002/pon.4502
    1. Ehrbar V, Urech C, Rochlitz C, et al. . Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. Hum Reprod 2019;34:1726–34. 10.1093/humrep/dez136
    1. Stacey D, Kryworuchko J, Belkora J, et al. . Coaching and guidance with patient decision AIDS: a review of theoretical and empirical evidence. BMC Med Inform Decis Mak 2013;13:S11 10.1186/1472-6947-13-S2-S11
    1. Raghunathan NJ, Benedict C, Thom B, et al. . Young adult female cancer survivors' concerns about future children's health and genetic risk. J Adolesc Young Adult Oncol 2018;7:125–9. 10.1089/jayao.2017.0050
    1. Benedict C, Thom B, Friedman DN, et al. . Fertility information needs and concerns post-treatment contribute to lowered quality of life among young adult female cancer survivors. Support Care Cancer 2018;26:2209–15. 10.1007/s00520-017-4006-z
    1. Benedict C, McLeggon J-A, Thom B, et al. . “Creating a family after battling cancer is exhausting and maddening”: Exploring real-world experiences of young adult cancer survivors seeking financial assistance for family building after treatment. Psychooncology 2018;27:2829–39. 10.1002/pon.4898
    1. Benedict C, Thom B, Kelvin JF. Fertility preservation and cancer: challenges for adolescent and young adult patients. Curr Opin Support Palliat Care 2016;10:87–94. 10.1097/SPC.0000000000000185
    1. Kelvin JF, Thom B, Benedict C, et al. . Cancer and fertility program improves patient satisfaction with information received. J Clin Oncol 2016;34:1780–6. 10.1200/JCO.2015.64.5168
    1. Benedict C, Thom B, Kelvin JF. Young adult female cancer survivors' decision regret about fertility preservation. J Adolesc Young Adult Oncol 2015;4:213–8. 10.1089/jayao.2015.0002
    1. Thom B, Benedict C, Friedman DN, et al. . The intersection of financial toxicity and family building in young adult cancer survivors. Cancer 2018;124:3284–9. 10.1002/cncr.31588
    1. Hagger MS, Koch S, Chatzisarantis NLD, et al. . The common sense model of self-regulation: meta-analysis and test of a process model. Psychol Bull 2017;143:1117–54. 10.1037/bul0000118
    1. Donovan EE, Brown LE, LeFebvre L, et al. . “The uncertainty is what is driving me crazy”: the tripartite model of uncertainty in the adolescent and young adult cancer context. Health Commun 2015;30:702–13. 10.1080/10410236.2014.898193
    1. Sepucha KR, Borkhoff CM, Lally J, et al. . Establishing the effectiveness of patient decision AIDS: key constructs and measurement instruments. BMC Med Inform Decis Mak 2013;13:S12 10.1186/1472-6947-13-S2-S12
    1. U.S. department of health and human services. HHS web standards and usability guidelines. . Available: [Accessed 24 May 2019].
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Warner EL, Kent EE, Trevino KM, et al. . Social well-being among adolescents and young adults with cancer: a systematic review. Cancer 2016;122:1029–37. 10.1002/cncr.29866
    1. Armuand GM, Wettergren L, Rodriguez-Wallberg KA, et al. . Desire for children, difficulties achieving a pregnancy, and infertility distress 3 to 7 years after cancer diagnosis. Support Care Cancer 2014;22:2805–12. 10.1007/s00520-014-2279-z
    1. Armuand GM, Wettergren L, Rodriguez-Wallberg KA, et al. . Women more vulnerable than men when facing risk for treatment-induced infertility: a qualitative study of young adults newly diagnosed with cancer. Acta Oncol 2015;54:243–52. 10.3109/0284186X.2014.948573
    1. Armuand GM, Rodriguez-Wallberg KA, Wettergren L, et al. . Sex differences in fertility-related information received by young adult cancer survivors. JCO 2012;30:2147–53. 10.1200/JCO.2011.40.6470
    1. Pera A. Psychopathological processes involved in social comparison, depression, and Envy on Facebook. Front Psychol 2018;9:22 10.3389/fpsyg.2018.00022
    1. Baker DA, Algorta GP. The relationship between online social networking and depression: a systematic review of quantitative studies. Cyberpsychol Behav Soc Netw 2016;19:638–48. 10.1089/cyber.2016.0206
    1. Durand M-A, Witt J, Joseph-Williams N, et al. . Minimum standards for the certification of patient decision support interventions: feasibility and application. Patient Educ Couns 2015;98:462–8. 10.1016/j.pec.2014.12.009
    1. Coulter A, Stilwell D, Kryworuchko J, et al. . A systematic development process for patient decision AIDS. BMC Med Inform Decis Mak 2013;13:S2 10.1186/1472-6947-13-S2-S2
    1. Decision Aid Toolkit - Patient Decision Aids - Ottawa Hospital Research Institute. Available: [Accessed 4 Jun 2019].
    1. Sepucha KR, Abhyankar P, Hoffman AS, et al. . Standards for universal reporting of patient decision aid evaluation studies: the development of SUNDAE checklist. BMJ Qual Saf 2018;27:380–8. 10.1136/bmjqs-2017-006986
    1. Hou S-I. Health literacy online: a guide to writing and designing easy-to-use health web sites. Health Promot Pract 2012;13:577–80. 10.1177/1524839912446480
    1. Turner-McGrievy GM, Hales SB, Schoffman DE, et al. . Choosing between responsive-design websites versus mobile apps for your mobile behavioral intervention: presenting four case studies. Transl Behav Med 2017;7:224–32. 10.1007/s13142-016-0448-y
    1. Docherty SL, Crane S, Haase JE, et al. . Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials. Int J Adolesc Med Health 2019. 10.1515/ijamh-2018-0215
    1. Topolovec-Vranic J, Natarajan K. The use of social media in recruitment for medical research studies: a scoping review. J Med Internet Res 2016;18:e286 10.2196/jmir.5698
    1. O'Connor AM. Validation of a decisional conflict scale. Med Decis Making 1995;15:25–30. 10.1177/0272989X9501500105
    1. Gorman JR, Su HI, Pierce JP, et al. . A multidimensional scale to measure the reproductive concerns of young adult female cancer survivors. J Cancer Surviv 2014;8:218–28. 10.1007/s11764-013-0333-3
    1. Weiss DS. The Impact of Event Scale: Revised : Wilson JP, Tang CS, Cross-Cultural Assessment of Psychological Trauma and PTSD. International and Cultural Psychology Series. Boston, MA: Springer US, 2007: 219–38.
    1. Moss-Morris R, Weinman J, Petrie K, et al. . The revised illness perception questionnaire (IPQ-R). Psychol Health 2002;17:1–16. 10.1080/08870440290001494
    1. Salsman JM, Schalet BD, Merluzzi TV, et al. . Calibration and initial validation of a general self-efficacy item bank and short form for the NIH PROMIS®. Qual Life Res 2019;28:2513–23. 10.1007/s11136-019-02198-6
    1. Gruber-Baldini AL, Velozo C, Romero S, et al. . Validation of the PROMIS® measures of self-efficacy for managing chronic conditions. Qual Life Res 2017;26:1915–24. 10.1007/s11136-017-1527-3
    1. Kelly L, Ziebland S, Jenkinson C. The e-health impact questionnaire: developing a tool to measure the effects of using health-related websites. Value in Health 2013;16 10.1016/j.jval.2013.08.1725
    1. Carcioppolo N, Yang F, Yang Q, Reducing YQ. Reducing, maintaining, or escalating uncertainty? the development and validation of four uncertainty preference scales related to cancer information seeking and avoidance. J Health Commun 2016;21:979–88. 10.1080/10810730.2016.1184357
    1. Abel T, Hofmann K, Ackermann S, et al. . Health literacy among young adults: a short survey tool for public health and health promotion research. Health Promot Int 2015;30:725–35. 10.1093/heapro/dat096
    1. Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med 2004;36:588–94.
    1. de Souza JA, Yap BJ, Hlubocky FJ, et al. . The development of a financial toxicity patient-reported outcome in cancer: the cost measure. Cancer 2014;120:3245–53. 10.1002/cncr.28814
    1. Prawitz A, Garman ET, Sorhaindo B, et al. . Incharge financial Distress/Financial well-being scale: development, administration, and score interpretation. Journal of Financial Counseling and Planning 2006;17.
    1. Peate M, Meiser B, Cheah BC, et al. . Making hard choices easier: a prospective, multicentre study to assess the efficacy of a fertility-related decision aid in young women with early-stage breast cancer. Br J Cancer 2012;106:1053–61. 10.1038/bjc.2012.61
    1. Murphy D, Orgel E, Termuhlen A, et al. . Why healthcare providers should focus on the fertility of AYA cancer survivors: it’s not too late! Front Oncol 2013;3:248 10.3389/fonc.2013.00248
    1. Gorman JR, Whitcomb BW, Standridge D, et al. . Adoption consideration and concerns among young adult female cancer survivors. J Cancer Surviv 2017;11:149–57. 10.1007/s11764-016-0572-1

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe