Video intervention increases participation of black breast cancer patients in therapeutic trials.
Ontology highlight
ABSTRACT:
SUBMITTER: Robinson BN
PROVIDER: S-EPMC5603544 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
Publications
Video intervention increases participation of black breast cancer patients in therapeutic trials.
Robinson Brandi N BN Newman Antoinette F AF Tefera Eshetu E Herbolsheimer Pia P Nunes Raquel R Gallagher Christopher C Randolph-Jackson Pamela P Omogbehin Adedamola A Dilawari Asma A Pohlmann Paula R PR Mohebtash Mahsa M Lee Young Y Ottaviano Yvonne Y Mohapatra Avani A Lynce Filipa F Brown Richard R Mete Mihriye M Swain Sandra M SM
NPJ breast cancer 20170918
There is a striking racial and ethnic disparity in incidence and mortality of cancer yet minorities remain markedly underrepresented in clinical trials. This pilot study set out to determine the impact of a 15-min culturally tailored educational video on three outcomes relating to clinical trials: likely participation, attitudes (assessed based on six barriers), and actual enrollment. Breast cancer patients with Stage I-III, if diagnosed within previous 6 months, or metastatic disease who self-i ...[more]
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Project description:BackgroundOver the past years knowledge about benefits of physical activity after cancer is evolving from randomized exercise intervention trials. However, it has been argued that results may be biased by selective participation. Therefore, we investigated factors influencing participation in a randomized exercise intervention trial for breast cancer patients.MethodsNon-metastatic breast cancer patients were systematically screened for a randomized exercise intervention trial on cancer-related fatigue. Participants and nonparticipants were compared concerning sociodemographic characteristics (age, marital status, living status, travel time to the training facility), clinical data (body-mass-index, tumor stage, tumor size and lymph node status, comorbidities, chemotherapy), fatigue, and physical activity. Reasons for participation or declination were recorded.Results117 patients (52 participants, 65 nonparticipants) were evaluable for analysis. Multiple regression analyses revealed significantly higher odds to decline participation among patients with longer travel time (p=0.0012), living alone (p=0.039), with more comorbidities (0.031), previous chemotherapy (p=0.0066), of age≥70 years (p=0.025), or being free of fatigue (p=0.0007). No associations were found with BMI or physical activity. By far the most frequently reported reason for declination of participation was too long commuting time to the training facility.ConclusionsWillingness of breast cancer patients to participate in a randomized exercise intervention study differed by sociodemographic factors and health status. Neither current physical activity level nor BMI appeared to be selective for participation. Reduction of personal inconveniences and time effort, e.g. by decentralized training facilities or flexible training schedules, seem most promising for enhancing participation in exercise intervention trials.Trial registrationRegistered at ClinicalTrials.gov: NCT01468766 (October 2011).
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Project description:PurposeThe decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials.MethodsWe conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): "How much of a burden on you is the cost of your medical care?," "I'm afraid that my health insurance won't pay for a clinical trial," and "I'm worried that I wouldn't be able to afford the costs of treatment on a clinical trial." Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics.ResultsOne thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models).ConclusionFinancial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients' financial needs and concerns may reduce distress and improve patient decision making.
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Project description:barriers to randomised clinical trial (RCT) recruitment include failure to identify eligible patients, reluctance of staff to approach them and attitudes of some health-care professionals and patients. As part of a larger UK prospective study examining the communication and involvement in RCTs of 22 multidisciplinary teams in Wales, we also assessed the attitudes of patients they treat towards trials.out of 1146 patients attending outpatient departments who were approached, 1146 (93%) completed the seven-item Attitudes to Randomised Trials Questionnaire (ARTQ), probing their general attitudes towards medical research and likely participation in a hypothetical two-arm RCT.randomisation initially deterred many patients from endorsing a willingness to participate. However, if information about the trial logic, voluntary nature and rights to withdraw were provided, together with further treatment details, 83% (886 out of 1066) would potentially participate. Other variables associated with a positive inclination towards participation included previous trial experience (P<0.01), male gender (P<0.01) and younger age, with patients > or =70 years less likely to consider trial entry (P<0.01).the majority of patients were receptive to RCT participation. Many of those initially disinclined because of randomisation would consider joining if given further details that form part of standard GCP consent guidelines. These data show the importance and need for clear communication and information to encourage RCT participation. Evidence-based training courses are available to assist with this.
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Project description:BackgroundThere are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs) of cancer treatments.MethodsA systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted.ResultsEight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work.ConclusionThere is not a strong evidence-base for interventions that increase cancer patient participation in randomised trials. Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials.
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Project description:ImportanceFollowing treatment, breast cancer survivors face challenges participating in valued activities.ObjectiveTo determine whether a telephone-based coaching rehabilitation intervention enhances activity participation in the year following breast cancer treatment.Design, setting, and participantsIn this multisite, single-blind randomized clinical trial (Optimizing Functional Recovery of Breast Cancer Survivors), recruitment occurred between August 28, 2019, and April 30, 2022. Data collection was completed by April 1, 2023. Participants were recruited from 2 cancer centers (Dartmouth College and the University of Alabama at Birmingham) and via social media advertisements. Women aged 18 years or older who had completed primary treatment for stage I to III breast cancer within 1 year and reported participation restrictions were eligible to participate. Randomization was stratified by site, treatment, and time since treatment.InterventionsThe intervention, delivered via telephone over 9 sessions, used behavioral activation and problem-solving principles to promote activity participation. The education-based attention control condition was delivered via telephone at matched intervals.Main outcomes and measuresThe primary outcome was participation, assessed using 5 measures, including Patient-Reported Outcomes Measurement Information System (PROMIS) social participation-satisfaction measure. One individualized outcome allowed participants to specify activities for which they wanted to foster recovery. Outcomes were collected by telephone by blinded coordinators at baseline and at 8, 20, and 44 weeks. The individualized outcome was assessed at the first and last intervention and control session.ResultsAmong 1996 patients identified, 303 were eligible and enrolled. Of these, 284 women (94%; mean [SD] age, 56.1 [10.2] years) completed baseline assessments and were randomized, and 81% or more of each group completed the final assessment with no adverse events. Of those who completed the final assessment, 118 of 114 (82%) were in the intervention group, and 113 of 140 (81%) were attention control participants. Between-group differences were not statistically significant for the main measures of PROMIS satisfaction (week 20: Cohen d, 0.1 [95% CI, -0.09 to 0.29] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]) and ability (week 20: Cohen d, 0.15 [95% CI, -0.06 to 0.37] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]). On the individualized outcome, intervention participants reported significantly greater improvements in activity satisfaction (Cohen d, 0.76 [95% CI, 0.48-1.02]) and performance (Cohen d, 0.60 [95% CI, 0.32-0.87]).Conclusions and relevanceIn this randomized clinical trial, the intervention catalyzed greater improvements in self-selected activity participation and goal disengagement but did not otherwise accelerate recovery compared with the control condition. Future research should determine what intervention features may lead to the greatest reductions in participation restrictions and other measures that may detect functional recovery.Trial registrationClinicalTrials.gov Identifier: NCT03915548.
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Project description:BackgroundAnthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC can reduce the proportion of BCa patients with functional disability (peak VO2, < 18 ml/kg/min), and 2) compare current standard-of-care for detecting cardiac dysfunction (resting left-ventricular ejection fraction assessed from 3-dimensional echocardiography) to measures of cardiac reserve (peak exercise cardiac output assessed from exercise cardiac magnetic resonance imaging) for predicting the development of functional disability 12-months following AC. Secondary aims are to assess the effects of ET on VO2peak, left ventricular morphology, vascular stiffness, cardiac biomarkers, body composition, bone mineral density, muscle strength, physical function, habitual physical activity, cognitive function, and multidimensional quality of life.MethodsOne hundred women with early-stage BCa (40-75 years) scheduled for AC will be randomized to 12-months of structured exercise training (n = 50) or a usual care control group (n = 50). Participants will be assessed at baseline, 4-weeks following completion of AC (4-months) and at 12-months for all measures.DiscussionWomen diagnosed with early-stage BCa have increased cardiac mortality. More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.Trial registrationAustralia & New Zealand Clinical Trials Registry (ANZCTR), ID: 12617001408370 . Registered on 5th of October 2017.
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Project description:Despite significant declines, adolescent birth rates in the USA are higher than other industrialized countries, with black and Hispanic youth disproportionately affected. This study assessed the efficacy of a single-session, entertainment-education sexual health video intervention for these populations. Using an individual-level randomized controlled trial, 1770 18- to 19-year-old black and Hispanic females were assigned to watch Plan A (n = 886) or a control video (n = 884) prior to a sexual reproductive health (SRH) visit. Participants self-reported data at baseline and 3 months post-baseline. Within an intent-to-treat framework, we estimated the average causal effect of assignment to Plan A on three confirmatory and five exploratory outcomes. We found that individuals assigned to Plan A had higher contraceptive knowledge, may be more likely to get sexually transmitted infection (STI) testing, and may have elevated HIV/STI risk perceptions 3 months post-video. Although we found no difference in long-acting reversible contraception (LARC) use nor frequency of condomless sex in the full sample, we did observe that first-time SRH visitors assigned to Plan A had a higher probability of using LARC than those in the control group. This study demonstrates that Plan A is a low-burden, inexpensive, and highly scalable video intervention for black and Hispanic adolescent females that has significant and borderline significant effects on protective sexual health behaviors and important antecedents. It adds to the evidence base of effective teen pregnancy prevention programs and the limited set of rigorous and causal studies investigating the effectiveness of entertainment-education interventions on sexual risk reduction. Registered in ClinicalTrials.gov (NCT03238313) on August 3, 2017.
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