Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT)

Linda O'Neill, Peter Knapp, Suzanne L Doyle, Emer Guinan, Adwoa Parker, Ricardo Segurado, Deirdre Connolly, Jacintha O'Sullivan, John V Reynolds, Juliette Hussey, Linda O'Neill, Peter Knapp, Suzanne L Doyle, Emer Guinan, Adwoa Parker, Ricardo Segurado, Deirdre Connolly, Jacintha O'Sullivan, John V Reynolds, Juliette Hussey

Abstract

Background: Whilst the potential benefits of exercise rehabilitation in cancer survivorship are plentiful, recruitment to survivorship rehabilitation trials remains suboptimal. There is growing evidence that Public and Patient Involvement (PPI) initiatives can increase the rate of recruitment to research. This study within a trial (SWAT) will examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention and understanding of the Rehabilitation Strategies in Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial when compared to standard participant information. Methods: This SWAT will be carried out over two phases. Phase I will utilise qualitative methods to develop (Phase Ia) and refine (Phase Ib) the new participant information. Phase Ia will recruit up to 20 survivors of upper gastrointestinal or hepatopancreaticobiliary cancer, or their family members, to take part in a focus group or interview to develop the new participant information. Focus groups/interviews will be recorded, transcribed verbatim and analysed thematically. In Phase Ib, participants will return for a second focus group/interview to refine the participant information. Once finalised, the participant information will be submitted to ethics for approval. In Phase II, potential participants for the ReStOre II trial will be randomly assigned to receive either the standard or patient and family co-developed participant information. The two forms of participant information will be compared by recruitment and retention rates, and participant understanding of the trial (Decision-Making Questionnaire). Discussion: We anticipate that engaging with patients and their families to develop participant information will help to increase patient understanding of the ReStOre II trial and therefore recruitment and retention rates. The results of this SWAT will indicate the usefulness of this strategy for optimising recruitment to exercise rehabilitation trials in cancer survivorship. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store ( SWAT-100). ReStOre II: ClinicalTrials.gov ( NCT03958019).

Keywords: SWAT; participant information; public and patient involvement; recruitment; retention; trial understanding.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2020 O'Neill L et al.

Figures

Figure 1.. Study design.
Figure 1.. Study design.
ReStOre, Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer.

References

    1. Nekhlyudov L, Mollica MA, Jacobsen PB, et al. : Developing a Quality of Cancer Survivorship Care Framework: Implications for Clinical Care, Research and Policy. J Natl Cancer Inst. 2019; pii: djz089. 10.1093/jnci/djz089
    1. Feuerstein M: Optimizing cancer survivorship. J Cancer Surviv. 2007;1(1):1–4. 10.1007/s11764-006-0001-y
    1. O'Connor M, O'Donovan B, Drummond F, et al. : The Unmet needs of cancer survivors in Ireland: A Scoping Review.N.C.R. Ireland, Editor; Cork.2019.
    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):1409–26. 10.1249/MSS.0b013e3181e0c112
    1. Irwin ML, Cadmus L, Alvarez-Reeves M, et al. : Recruiting and retaining breast cancer survivors into a randomized controlled exercise trial: the Yale Exercise and Survivorship Study. Cancer. 2008;112(11 Suppl):2593–606. 10.1002/cncr.23446
    1. Crocker JC, Ricci-Cabello I, Parker A, et al. : Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. BMJ. 2018;363:k4738. 10.1136/bmj.k4738
    1. Hoddinott P, Pollock A, O'Cathain A, et al. : How to incorporate patient and public perspectives into the design and conduct of research [version 1; peer review: 3 approved, 2 approved with reservations]. F1000Res. 2018;7:752. 10.12688/f1000research.15162.1
    1. Kearney A, Williamson P, Young B, et al. : Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process. Health Expect. 2017;20(6):1401–1410. 10.1111/hex.12583
    1. Brett J, Staniszewska S, Mockford C, et al. : Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect. 2014;17(5):637–650. 10.1111/j.1369-7625.2012.00795.x
    1. Parker A, Knapp P, Treweek S, et al. : The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial. Trials. 2018;19(1):503. 10.1186/s13063-018-2896-9
    1. Cox AC, Fallowfield LJ, Jenkins VA: Communication and informed consent in phase 1 trials: a review of the literature. Support Care Cancer. 2006;14(4):303–309. 10.1007/s00520-005-0916-2
    1. O'Neill LM, Guinan E, Doyle SL, et al. : The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship. Ann Surg. 2018;268(5):747–755. 10.1097/SLA.0000000000002895
    1. Bennett AE, O'Neill L, Connolly D, et al. : Patient experiences of a physiotherapy-led multidisciplinary rehabilitative intervention after successful treatment for oesophago-gastric cancer. Support Care Cancer. 2018;26(8):2615–2623. 10.1007/s00520-018-4112-6
    1. Adams RN, Mosher CE, Blair CK, et al. : Cancer survivors’ uptake and adherence in diet and exercise intervention trials: an integrative data analysis. Cancer. 2015;121(1):77–83. 10.1002/cncr.28978
    1. O'Neill L: Patient and Family Co-developed Participant Information to Improve Recruitment Rates, Retention, and Patient Understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (restore II) Trial: Protcol for a Study Within a Trial (SWAT), 2019. OSF2019. 10.17605/
    1. Hartnett T: Consensus-orientated Decision-making: the CODM Model for Facilitating Groups to Widespread Agreement. Gabriola Island: New Society Publishers. 2011.
    1. Braun V, Clarke V: Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. 10.1191/1478088706qp063oa
    1. Kensing F, Blomberg J: Participatory Design: Issues and Concerns. Comput Support Coop Work. 1998;7(3):167–185. 10.1023/A:1008689307411
    1. Martin-Kerry JM, Knapp P, Atkin K, et al. : Supporting children and young people when making decisions about joining clinical trials: qualitative study to inform multimedia website development. BMJ Open. 2019;9(1):e023984. 10.1136/bmjopen-2018-023984
    1. Martin-Kerry J, Bower P, Young B, et al. : Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials. Trials. 2017;18(1):265. 10.1186/s13063-017-1962-z
    1. Adamson J, Hewitt CE, Torgerson DJ: Producing better evidence on how to improve randomised controlled trials. BMJ. 2015;351:h4923. 10.1136/bmj.h4923
    1. Healthy Ireland, Department of Health, and N.P.S. Office: National Cancer Strategy 2017-2026. Ireland.2017.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅