A Systematic Review of Strategies Used to Increase Recruitment of People With Cancer or Organ Failure Into Clinical Trials: Implications for Palliative Care Research

Boland, Jason W; Currow, David C.; Wilcock, Andrew; Tieman, Jennifer; Hussain, Jamilla; Pitsillides, Constantine; Abernethy, Amy Pickar; Johnson, Miriam J.

doi:10.1016/j.jpainsymman.2014.09.018

Cited by 45 publications

(50 citation statements)

References 95 publications

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“…Based on our experiences in the two exemplars and those that other researchers describe in the literature among similar populations (Boland et al, 2015; Bruner & O’Mara, 2014; Mackin et al, 2009; McMillan & Weitzner, 2003; Steinhauser et al, 2006; Treweek et al, 2010), investigators can implement a number of strategies to address the challenges described earlier.…”

Section: Solutions To Recruitment Challengesmentioning

confidence: 99%

“…Opt-in rather than opt-procedures that require less effort from the patient and family may also aid recruitment of participants into biobehavioral studies (Boland et al, 2015; Mackin et al, 2009; Steinhauser et al, 2006). Recruitment materials geared toward audiovisual learners can help overwhelmed patients and families who may be experiencing cognitive fatigue and are not able to focus on written materials (Treweek et al, 2010).…”

Section: Solutions To Recruitment Challengesmentioning

confidence: 99%

“…Emphasizing the potential benefits (if there are any) of study participation and benefits to future patients and families like them may also be helpful. Finally, using sources of data other than those collected directly from participants whenever possible (e.g., validated proxy measures, medical record data, clinical trial measures) may help to minimize perceived study burden (Boland et al, 2015; Treweek et al, 2010). …”

Section: Solutions To Recruitment Challengesmentioning

confidence: 99%

See 2 more Smart Citations

Conducting Biobehavioral Research in Patients With Advanced Cancer: Recruitment Challenges and Solutions

Gilbertson‐White

Bohr

Wickersham

2017

Biological Research For Nursing

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Despite significant advances in cancer treatment and symptom management interventions over the last decade, patients continue to struggle with cancer-related symptoms. Adequate baseline and longitudinal data are crucial for designing interventions to improve patient quality of life and reduce symptom burden; however, recruitment of patients with advanced cancer in longitudinal research is difficult. Our purpose is to describe challenges and solutions to recruitment of patients with advanced cancer in two biobehavioral research studies examining cancer-related symptoms. Study 1: Symptom data and peripheral blood for markers of inflammation were collected from newly diagnosed patients receiving chemotherapy on the first day of therapy and every 3–4 weeks for up to 6 months. Study 2: Symptom data, blood, and skin biopsies were collected from cancer patients taking epidermal growth factor receptor inhibitors at specific time points over 4 months. Screening and recruitment results for both studies are summarized. Timing informed consent with baseline data collection prior to treatment initiation was a significant recruitment challenge for both the studies. Possible solutions include tailoring recruitment to fit clinic needs, increasing research staff availability during clinic hours, and adding recruitment sites. Identifying solutions to these challenges will permit the conduct of studies that may lead to identification of factors contributing to variability in symptoms and development of tailored patient interventions for patients with advanced cancer.

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Section: Solutions To Recruitment Challengesmentioning

confidence: 99%

Section: Solutions To Recruitment Challengesmentioning

confidence: 99%

Section: Solutions To Recruitment Challengesmentioning

confidence: 99%

See 1 more Smart Citation

Conducting Biobehavioral Research in Patients With Advanced Cancer: Recruitment Challenges and Solutions

Gilbertson‐White

Bohr

Wickersham

2017

Biological Research For Nursing

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“…Eligibility can be a major limiting factor affecting recruitment in advanced disease. Trials often need to screen 10-15 patients to recruit 1, and strategies to improve recruitment have had variable success [3][4][5][6][7][8][9][10][11]. To advance the evidence base in palliative care we need high-quality clinical trials, including Clinical Trials of an Investigational Medicinal Product, of which there are few, in part due to these challenges [12].…”

Section: Introductionmentioning

confidence: 99%

What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study

Lovell

Etkind

Maddocks

et al. 2020

Trials

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Background: Recruitment and retention in clinical trials remains an important challenge, particularly in the context of advanced disease. It is important to understand what affects retention to improve trial quality, minimise attrition and reduce missing data. We conducted a qualitative study embedded within a randomised feasibility trial and explored what influenced people to take part and remain in the trial. Methods: We conducted a qualitative study embedded within a double-blind randomised trial (BETTER-B[Feasibility]: BETter TreatmEnts for Refractory Breathlessness) designed using a person-centred approach. Participants with cancer, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or chronic heart failure (CHF), with a modified Medical Research Council dyspnoea scale grade of 3/4 were recruited from three UK sites. A convenience subsample completed qualitative interviews after the trial. Interviews were analysed using thematic analysis. Results were considered in relation to the core elements of person-centred care and our model of the person-centred trial. Results: In the feasibility trial 409 people were screened for eligibility, and 64 were randomised. No participant was lost to follow-up. Twenty-two participants took part in a qualitative interview. Eleven had a diagnosis of COPD, 8 ILD, 2 CHF and 1 lung cancer. The participants' median age was 71 years (range 56-84). Sixteen were male. Twenty had completed the trial, and two withdrew due to adverse effects. The relationship between patient and professional, potential for benefit, trial processes and the intervention all influenced the decision to participate in the trial. The relationship with the research team and continuity, perceived benefit, and aspects relating to trial processes and the intervention influenced the decision to remain in the trial. Conclusions: In this feasibility trial recruitment targets were met, attrition levels were low, and aspects of the personcentred approach were viewed positively by trial participants. Prioritisation of the relationship between the patient and professional; person-centred processes, including home visits, assistance with questionnaires, and involvement of the carer; and enabling people to participate by having processes in line with individual capabilities appear to support recruitment and retention in clinical trials in advanced disease. We recommend the integration of a person-centred approach in all clinical trials.

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“…Research within Clinical Trials Units (CTUs) has considered methods that may improve recruitment and retention, identifying the importance of support and training for researchers and clinicians, and choice of appropriate outcome measures (14,20). However, strategies to improve recruitment into trials have had variable success (3). As more people approach the end of their lives with chronic and complex conditions, the need for robust research and evidence has never been greater, however clinical trials in palliative care remain sparse often limited by poor funding and methodological weaknesses (2,21,22).…”

Section: Introductionmentioning

confidence: 99%

What influenced people with chronic breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study.

Lovell

Etkind

Maddocks³

et al. 2019

Preprint

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Background Recruitment and retention in clinical trials remains an important challenge, particularly in the context of advanced disease. It is important to understand what affects retention to improve trial quality, minimise attrition and reduce missing data. We conducted a qualitative study embedded within a randomised feasibility trial and explored what influenced people to take part and remain in the trial. Methods Qualitative study embedded within a double blind randomised trial designed using a person-centred approach. Participants with cancer, Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), or Chronic Heart Failure (CHF), with a Modified Medical Research Council Dyspnoea Scale grade 3/4 were recruited from three UK sites. A convenience subsample completed qualitative interviews after the trial. Interviews were analysed using thematic analysis. Results were considered in relation to the core elements of person-centred care and our model of the person-centred trial. Results In the feasibility trial 409 people were screened for eligibility and 64 randomised. No participant was lost to follow up. 22 participants provided qualitative interviews. 11 had a diagnosis of COPD, 8 ILD, 2 CHF, and 1 lung cancer. Median age was 71 years (56-84). 16 were male. 20 had completed the trial, 2 withdrew due to adverse effects. The relationship between patient and professional, potential for benefit, trial processes and the intervention all influenced the decision to participate in the trial. The relationship with the research team and continuity, perceived benefit, and aspects relating to trial processes and the intervention influenced the decision to remain in the trial. Conclusions In this feasibility trial recruitment targets were met, attrition levels were low, and aspects of the person-centred approach were viewed positively by trial participants. Prioritisation of the relationship between the patient and professional, ensuring a person-centred trial design, and enabling people to participate by having processes in line with individual capabilities may support recruitment and retention in clinical trials in advanced disease. We would recommend the integration of a person-centred approach in all clinical trials.

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A Systematic Review of Strategies Used to Increase Recruitment of People With Cancer or Organ Failure Into Clinical Trials: Implications for Palliative Care Research

Abstract: Successful strategies from other disciplines could be considered by palliative care researchers. Tailored, efficient, evidence-based strategies must be developed, acknowledging that strategies with face validity are not necessarily the most effective.

Cited by 45 publications

References 95 publications

Conducting Biobehavioral Research in Patients With Advanced Cancer: Recruitment Challenges and Solutions

Conducting Biobehavioral Research in Patients With Advanced Cancer: Recruitment Challenges and Solutions

What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study

What influenced people with chronic breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study.

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