Abstract
Background: Patients on clinical trials experience numerous quality of life (QOL) concerns, including those associated with advancing disease. This pilot project tested the feasibility and initial outcomes of an advanced practice registered nurse (APRN)-led intervention for patients with gastrointestinal (GI) tumors transitioning after completing a phase I trial. Objectives: The objectives were to (1) Develop the “Transitions” care plan intervention based on prior research to support patient QOL including symptom management, psychosocial and spiritual support, and care after trial completion; (2) Test the feasibility of the intervention in a sample of patients with GI tumors; and (3) Evaluate the impact of the Transitions care plan intervention on improved care and QOL. Methods: A single-group, convenience sample of patients with GI tumors completing phase I clinical trials was accrued at a National Cancer Institute–designated Comprehensive Cancer Center in the western US. Patients completed questionnaires at baseline, 3 months, and 6 months. Interviews were conducted at 3 months for further understanding of patient needs. A Transitions care plan for the patient was developed by the APRN in collaboration with the patient and medical oncologist. Chart audits were conducted to capture supportive services referrals and completions. Key variables included domains of QOL, distress, and use of supportive care services. Results: Patients (N = 37) had significant needs for support across all QOL domains. The Transitions care plan model was valuable in assessing QOL needs, facilitating patients’ understanding of disease status, and providing access to supportive care services. Implications: APRNs can develop a model of care to support patients completing clinical trials.
References
Anderson, T. M., Farrell, M. M., Moss, G., Gupta, M., Mooney, S., Daunov, K., Savernick, M., Frandsen, J., Verrona, K., Pecoraro, A., Mance, C., Garcia, J., & Lee, R. T. (2022). The perspectives of oncology healthcare providers on the role of palliative care in a comprehensive cancer center. BMC Palliative Care, 21(1), 148. https://doi.org/10.1186/s12904-022-01039-7
Bredle, J. M., Salsman, J. M., Debb, S. M., Arnold, B. J., & Cella, D. (2011). Spiritual well-being as a component of health-related quality of life: The functional assessment of chronic illness therapy—spiritual well-being scale (FACIT-Sp). Religions, 2(1), 77–94.
Canzona, M. R., Love, D., Barrett, R., Henley, J., Bridges, S., Koontz, A., Nelson, S., & Daya, S. (2018). “Operating in the dark”: Nurses’ attempts to help patients and families manage the transition from oncology to comfort care. Journal of Clinical Nursing, 27(21–22), 4158–4167. https://doi.org/https://doi.org/10.1111/jocn.14603
Case Management Society of America. (2024). Promoting successful outcomes in making care primary: The role and value of case management [position paper]. https://cmsa.org/promoting-successfuloutcomes-in-making-care-primary/
Cella, D. F., Tulsky, D. S., Gray, G., Sarafian, B., Linn, E., Bonomi, A., Silberman, M., Yellen, S. B., Winicour, P., Brannon, J. (1993). The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. Journal of Clinical Oncology, 11(3), 570–579. https://doi.org/10.1200/JCO.1993.11.3.570
Cho, H. L., Danis, M., & Grady, C. (2018). Post-trial responsibilities beyond post-trial access. Lancet, 391(10129), 1478–1479. https://doi.org/10.1016/S0140-6736(18)30761-X
Ferrell, B., Chung, V., Hughes, M. T., Koczywas, M., Azad, N. S., Ruel, N. H., Knight, L., Cooper, R. S., & Smith, T. J. (2021). A palliative care intervention for patients on phase 1 studies. Journal of Palliative Medicine, 24(6), 846–856. https://doi.org/10.1089/jpm.2020.0597
Ferrell, B. R. (1996). The quality of lives: 1,525 voices of cancer. Oncology Nursing Forum, 23(6), 909–916. https://www.ncbi.nlm.nih.gov/pubmed/8829161
Finlay, E., Lu, H. L., Henderson, H. R., O’Dwyer, P. J., & Casarett, D. J. (2009). Do phase 1 patients have greater needs for palliative care compared with other cancer patients? Cancer, 115(2), 446–453. https://doi.org/10.1002/cncr.24025
Hlubocky, F. J., Sher, T. G., Cella, D., Wroblewski, K. E., Peppercorn, J., & Daugherty, C. K. (2021). Anxiety shapes expectations of therapeutic benefit in phase I trials for patients with advanced cancer and spousal caregivers. JCO Oncology Practice, 17(2), e101–e110.
Jacobsen, P. B., Donovan, K. A., Trask, P. C., Fleishman, S. B., Zabora, J., Baker, F., & Holland, J. C. (2005). Screening for psychologic distress in ambulatory cancer patients. Cancer, 103(7), 1494–1502. https://doi.org/10.1002/cncr.20940
Kessler, E. R., Moss, A., Eckhardt, S. G., Laudenslager, M. L., Kilbourn, K., Mauss, I. B., Bowles, D. W., Hecker, S., Fairclough, D. L., & Kutner, J. S. (2014). Distress among caregivers of phase I trial participants: a cross-sectional study. Supportive Care in Cancer, 22, 3331–3340.
Kimmelman, J. (2017). Is participation in cancer phase I trials really therapeutic? Journal of Clinical Oncology, 35(2), 135–138. https://doi.org/10.1200/jco.2016.67.9902
Kogan, N., Tolley, M., & Cohen, R. (2022). Family caregivers support their patient’s decision to participate in a phase 1 clinical trial: Weighing the pros and cons, bearing the costs. Psycho-Oncology, 31(8), 1374–1380. https://doi.org/10.1002/pon.5942
National Consensus Project for Quality Palliative Care. (2018). Clinical Practice Guidelines for Quality Palliative Care. https://www.nationalcoalitionhpc.org/ncp
Paluri, R. K., Li, P., Anderson, A., Nandagopal, L., McArdle, T., Young, M., Robert, F., Naik, G., & Saleh, M. (2020). First-in-human phase 1 clinical trials - a single-center experience in the era of modern oncotherapeutics. Scientific Reports, 10(1), 7935. https://doi.org/10.1038/s41598-020-64906-4
Rezash, V., Reed, J., Gedeon, B., Parsons, E., Siedlecki, S., Daniels, B., & Shepard, D. R. (2020). Who needs what? Perceptions of patients and caregivers in oncology phase 1 trials. Journal of Patient Experience, 7(1), 27–33. https://doi.org/10.1177/2374373519830743
Sanders, J. J., Temin, S., Ghoshal, A., Alesi, E. R., Ali, Z. V., Chauhan, C., Cleary, J. F., Epstein, A. S., Firn, J. I., Jones, J. A., Litzow, M. R., Lundquist, D., Mardones, M. A., Nipp, R. D., Rabow, M. W., Rosa, W. E., Zimmermann, C., & Ferrell, B. R. (2024). Palliative care for patients with cancer: ASCO Guideline Update. Journal of Clinical Oncology, JCO.24.00542. https://doi.org/10.1200/JCO.24.00542
Sedhom, R., Blackford, A. L., Gupta, A., Griffiths, K., Heussner, J., & Carducci, M. A. (2021). End-of-life characteristics associated with short hospice length of stay for patients with solid tumors enrolled in phase I clinical trials. Journal of the National Comprehensive Cancer Network, 19(6), 686–692. https://doi.org/10.6004/jnccn.2020.7646
Sedhom, R., Ferrell, B., Ruel, N., Koczywas, M., Chung, V., & Smith, T. J. (2020). Using patient reported outcomes to describe the patient experience on phase I clinical trials. JNCI Cancer Spectrum, 4(6), pkaa067. https://doi.org/10.1093/jncics/pkaa067
Sun, V., Cooke, L., Chung, V., Uman, G., Smith, T. J., & Ferrell, B. (2014). Feasibility of a palliative care intervention for cancer patients in phase I clinical trials. Journal of Palliative Medicine, 17(12), 1365–1368. https://doi.org/10.1089/jpm.2014.0108
Swenne, J. I. E., Hansen, T. F., Nissen, R. D., Steffensen, K. D., Stie, M., Søndergaard, J., & Jensen, L. H. (2024). Early integration of basic palliative care in cancer: Scoping review of cross-sectorial models – components, facilitators, barriers. BMJ Supportive & Palliative Care, spcare-2023-004651. https://doi.org/10.1136/spcare-2023-004651
Treasure, M., Daly, B., Cao, S., Fu, P., Hong, A., Weinstein, E., Surdam, J., Meropol, N. J., & Dowlati, A. (2021). A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials. Cancer Medicine, 10(13), 4312–4321. https://doi.org/10.1002/cam4.3971
Ulrich, C. M., & Grady, C. (2019). Time for advance care planning discussions during transitions in care in cancer clinical trials. JAMA Oncology, 5(4), 459–460. https://doi.org/10.1001/jamaoncol.2018.6872
Ulrich, C. M., Knafl, K., Foxwell, A. M., Zhou, Q., Paidipati, C., Tiller, D., Ratcliffe, S. J., Wallen, G. R., Richmond, T. S., Naylor, M., Gordon, T. F., Grady, C., & Miller, V. (2021). Experiences of patients after withdrawal from cancer clinical trials. JAMA Network Open, 4(8), e2120052. https://doi.org/10.1001/jamanetworkopen.2021.20052
Yang, G. M., Ong, W. Y., Tan, J., Ding, J., Ho, S., Tan, D., & Neo, P. (2023). Motivations and experiences of patients with advanced cancer participating in phase 1 clinical trials: A qualitative study. Palliative Medicine, 37(2), 257–264. https://doi.org/10.1177/02692163221137105
