Survivorship care plans: are randomized controlled trials assessing outcomes that are relevant to stakeholders?

  • Sarah A. Birken
  • Robin Urquhart
  • Corrine Munoz-Plaza
  • Alexandra R. Zizzi
  • Emily Haines
  • Angela Stover
  • Deborah K. Mayer
  • Erin E. Hahn
Article

Abstract

Purpose

The purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs’ effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs’ outcomes.

Methods

We identified RCTs’ outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs’ outcomes onto stakeholder-identified outcomes.

Results

RCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors’ perspectives.

Conclusions

RCTs of SCPs’ effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs’ effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders.

Implications for Cancer Survivors

SCPs’ effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.

Keywords

Survivorship care plans Stakeholders Outcomes Randomized controlled trials 

Notes

Compliance with ethical standards

The Institutional Review Board at the University of North Carolina at Chapel Hill exempted the study from human subjects review. The Research Ethics Board at NSHA and the Institutional Review Board at KPSC approved the study.

Conflict of interest

The authors declare that they have no conflicts of interest.

Supplementary material

11764_2018_688_MOESM1_ESM.docx (23 kb)
ESM 1 (DOCX 22.5 kb)
11764_2018_688_MOESM2_ESM.docx (24 kb)
ESM 2 (DOCX 23.7 kb)

References

  1. 1.
    Ganz PA. Late effects of cancer and its treatment. Semin Oncol Nurse. 2001;17(4):241–8.CrossRefGoogle Scholar
  2. 2.
    Urquhart R, Folkes A, Porter G, Kendell C, Cox M, Dewar R, et al. Population-based longitudinal study of follow-up care for colorectal cancer patients in Nova Scotia. J Oncol Pract. 2012;8(4):246–52.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Grunfeld E, Hodgson DC, Del Guidice ME, et al. Population-based longitudinal study of follow-up care for breast cancer survivors. J Oncol Pract. 2010;6(4):174–81.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Hahn EE, Hays RD, Kahn KL, Litwin MS, Ganz PA. Use of imaging and biomarker tests for post-treatment care of early stage breast cancer survivors. Cancer. 2013;119(24):4316–26.CrossRefPubMedGoogle Scholar
  5. 5.
    Hahn EE, Tang T, Lee JS, et al. Use of post-treatment imaging and biomarkers in early stake breast cancer survivors: inappropriate surveillance or necessary care? Cancer. 2016;122(6):908–16.CrossRefPubMedGoogle Scholar
  6. 6.
    Cheung WY, Neville BA, Cameron DB, Cook EF, Earle CC. Comparisons of patient and physician expectations for cancer survivorship care. J Clin Oncol. 2009;27(15):2489–95.CrossRefPubMedGoogle Scholar
  7. 7.
    Mallinger JB, Griggs JJ, Shields CG. Patient-centered care and breast cancer survivors’ satisfaction with information. Patient Educ Couns. 2005;57(3):342–9.CrossRefPubMedGoogle Scholar
  8. 8.
    Nicolaije KA, Husson O, Ezendam NP, et al. Endometrial cancer survivors are unsatisfied with received information about diagnosis, treatment and follow-up: a study from the population-based PROFILES registry. Patient Educ Couns. 2012;88(3):427–35.CrossRefPubMedGoogle Scholar
  9. 9.
    Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012;62(4):220–41.CrossRefPubMedGoogle Scholar
  10. 10.
    Institute of Medicine. In: Levit LA, et al., editors. Delivering high-quality cancer care: charting a new course for a system in crisis. Washington, DC: National Academy of Sciences; 2013.Google Scholar
  11. 11.
    National Cancer Survivorship Resource Center. Systems policy and practice: clinical survivorship care. Atlanta: American Cancer Society; 2011.Google Scholar
  12. 12.
    McCabe MS, Bhatia S, Oeffinger KC, et al. American Society of Clinical Oncology statement: achieving high-quality cancer survivorship care. J Clin Oncol. 2013;31(5):631–40.CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Commission on Cancer, American Cancer Society. Cancer program standards 2012: ensuring patient-centered care. Atlanta: American Cancer Society; 2012.Google Scholar
  14. 14.
    Shalom MM, Hahn EE, Casillas J, Ganz PA. Do survivorship care plans make a difference? A primary care provider perspective. J Oncol Pract. 2011;7(5):314–8.CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Grunfeld E, Julian JA, Pond G, Maunsell E, Coyle D, Folkes A, et al. Evaluating survivorship care plans: results of a randomized, clinical trial of patients with breast cancer. J Clin Oncol. 2011;29(36):4755–62.CrossRefPubMedGoogle Scholar
  16. 16.
    Boekhout AH, Maunsell E, Pond GR, et al. A survivorship care plan for breast cancer survivors: extended results of a randomized clinical trial. J Cancer Surviv. 2015;9:683–91.CrossRefPubMedGoogle Scholar
  17. 17.
    Coyle D, Grunfeld E, Coyle K, et al. Cost effectiveness of a survivorship care plan for breast cancer survivors. J Oncol Pract. 2013;10(2):e86–92.CrossRefPubMedGoogle Scholar
  18. 18.
    Brothers BM, Easley A, Salani R, Andersen BL. Do survivorship care plans impact patients’ evaluations of care? A randomized evaluation with gynecologic oncology patients. Gynecol Oncol. 2013;129(3):554–8.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, et al. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013;138:795–806.CrossRefPubMedGoogle Scholar
  20. 20.
    Nicolaije KA, Ezendam NP, Vos MC, et al. Impact of an automatically generated cancer survivorship care plan on patient-reported outcomes in routine clinical practice: longitudinal outcomes of a pragmatic cluster randomized trial. J Clin Oncol. 2015;33(31):3550–9.CrossRefPubMedGoogle Scholar
  21. 21.
    de Rooij BH, Ezendam NP, Nicolaije KA, et al. Effects of survivorship care plans on patient reported outcomes in ovarian cancer during 2-year follow-up—the ROGY care trial. Gynecol Oncol. 2017;145(2):319–28.CrossRefPubMedGoogle Scholar
  22. 22.
    Ruddy KJ, Guo H, Baker EL, Goldstein MJ, Mullaney EE, Shulman LN, et al. Randomized phase 2 trial of a coordinated breast cancer follow-up care program. Cancer. 2016;122:3546–54.CrossRefGoogle Scholar
  23. 23.
    Nicolaije KA, Ezendam NP, Pijnenborg JM, et al. Paper-based survivorship care plans may be less helpful for cancer patients who search for disease-related information on the internet: results of the Registrationsystem Oncological Gynecology (ROGY) care randomized trial. J Med Internet Res. 2016;18(7):e162.CrossRefPubMedPubMedCentralGoogle Scholar
  24. 24.
    Ezendam NP, Nicolaije KA, Kruitwagen RF, et al. Survivorship care plans to inform the primary care physician: results from the ROGY care pragmatic cluster randomized controlled trial. J Cancer Surviv. 2014;8:595–602.CrossRefPubMedGoogle Scholar
  25. 25.
    Maly RC, Liang L-J, Liu Y, et al. Randomized controlled trial of survivorship care plans among low-income, predominantly Latina breast cancer survivors. J Clin Oncol. 2017;35(16):1814–21.CrossRefPubMedGoogle Scholar
  26. 26.
    Kvale EA, Huang CH, Meneses KM, et al. Patient-centered support in the survivorship care transition: outcomes from the patient-owned survivorship care plan intervention. Cancer. 2016;122:3232–42.CrossRefPubMedGoogle Scholar
  27. 27.
    Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, et al. Comparing web-based provider-initiated and patient-initiated survivorship care planning for cancer patients: a randomized controlled trial. JMIR Cancer. 2016;2(2):e12.CrossRefPubMedPubMedCentralGoogle Scholar
  28. 28.
    Nicolaije KA, Ezendam NP, Vos MC, et al. Oncology providers’ evaluation of the use of an automatically generated cancer survivorship care plan: longitudinal results from the ROGY care trial. J Cancer Surviv. 2014;8:248–59.CrossRefPubMedGoogle Scholar
  29. 29.
    Blanchard CM, Courneya KS, Stein K. Cancer survivors’ adherence to lifestyle behavior recommendations and associations with health-related quality of life: results from the American Cancer Society’s SCS-II. J Clin Oncol. 2008;26(13):2198–204.CrossRefPubMedGoogle Scholar
  30. 30.
    Glaser BG, Strauss AL. Awareness of dying. Chicago: Aldine; 1965.Google Scholar
  31. 31.
    Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine; 1967.Google Scholar
  32. 32.
    Glaser BG. Basics of grounded theory analysis: emergence vs. forcing. Mill Valley: Sociology Press; 1992.Google Scholar
  33. 33.
    What is patient experience? Content last reviewed March 2017. Agency for Healthcare Research and Quality, Rockville. http://www.ahrq.gov/cahps/about-cahps/patient-experience/index.html.
  34. 34.
    Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Admin Pol Ment Health. 2011;38(2):65–76.CrossRefGoogle Scholar
  35. 35.
    Montazeri A. Health-related quality of life in breast cancer patients: a bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res. 2008;27:32.CrossRefPubMedPubMedCentralGoogle Scholar
  36. 36.
    Parry C, Kent EE, Forsythe LP, Alfano CM, Rowland JH. Can’t see the forest for the care plan: a call to revisit the context of care planning. J Clin Oncol. 2013;31(21):2651–3.CrossRefPubMedPubMedCentralGoogle Scholar
  37. 37.
    Franco BB, Dharmakulaseelan L, McAndrew A, Bae S, Cheung MC, Singh S. The experiences of cancer survivors while transitioning from tertiary to primary care. Curr Oncol. 2016;23(6):378–85.CrossRefPubMedPubMedCentralGoogle Scholar
  38. 38.
    Norris JM, White DE, Nowell L, Mrklas K, Stelfox HT. How do stakeholders from multiple hierarchical levels of a large provincial health system define engagement? A qualitative study. Implement Sci. 2017;12:98.CrossRefPubMedPubMedCentralGoogle Scholar
  39. 39.
    Selove R, Birken SA, Skolarus TA, Hahn EE, Sales A, Proctor EK. Using implementation science to explain the impact of cancer survivorship care plans. J Clin Oncol. 2016;34(43):3834–7.CrossRefPubMedPubMedCentralGoogle Scholar
  40. 40.
    Nolte L, Kinnane N, Lai-Kwon J, Gates P, Shilkin P, Jefford M. The impact of survivorship care planning on patients, general practitioners, and hospital-based staff. Cancer Nurs. 2016;39(6):E26–35.CrossRefPubMedGoogle Scholar
  41. 41.
    Reb A, Ruel N, Fakih M, Lai L, Salgia R, Ferrell B, et al. Empowering survivors after colorectal and lung cancer treatment: pilot study of a self-management survivorship care planning intervention. Eur J Oncol Nurs. 2017;29:125–34.CrossRefPubMedGoogle Scholar
  42. 42.
    Patient Centered Outcomes Research Institute (PCORI). https://www.pcori.org/about-us.
  43. 43.
    Canadian Institutes of Health Research. Canada’s strategy for patient-oriented research. http://www.cihr-irsc.gc.ca/e/44000.html.
  44. 44.
    Chadder J, Zomer S, on behalf of the Canadian Partnership Against Cancer and provincial investigators. Experiences of cancer patients in transition. Canadian Partnership Against Cancer System Performance Initiative and Person-Centred Perspective Grant ($1,550,000; 2015–2017).Google Scholar
  45. 45.
    Mays N, Pope C. Rigour and qualitative research. BMJ. 1995;311:109–12.CrossRefPubMedPubMedCentralGoogle Scholar
  46. 46.
    Harman NL, Bruce IA, Kirkham JJ, Tierney S, Callery P, O'Brien K, et al. The importance of integration of stakeholder views in core outcomes set development: otitis media with effusion in children with cleft palate. PLoS One. 2015;10(6):e0129514.CrossRefPubMedPubMedCentralGoogle Scholar
  47. 47.
    Rowland JH, Ganz PA. Cancer survivorship plans: a paradigm shift in the delivery of quality cancer care. In: Feuerstein M, Ganz PA, editors. Health services for cancer survivors. New York: Springer; 2011. p. 169–85.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Sarah A. Birken
    • 1
  • Robin Urquhart
    • 2
  • Corrine Munoz-Plaza
    • 3
  • Alexandra R. Zizzi
    • 1
  • Emily Haines
    • 1
  • Angela Stover
    • 1
  • Deborah K. Mayer
    • 4
  • Erin E. Hahn
    • 3
  1. 1.Department of Health Policy and Management, Gillings School of Global Public Health, Lineberger Comprehensive Cancer CenterThe University of North Carolina at Chapel HillChapel HillUSA
  2. 2.Department of SurgeryDalhousie UniversityHalifaxCanada
  3. 3.Department of Research and EvaluationKaiser Permanente ResearchPasadenaUSA
  4. 4.School of Nursing, Lineberger Comprehensive Cancer CenterThe University of North CarolinaChapel HillUSA

Personalised recommendations