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Study protocol: a randomized control trial of African American families fighting parental cancer together.

ABSTRACT: BACKGROUND:African American adults experience a disproportionate burden and increased mortality for most solid tumor cancers and their adolescent children are negatively impacted by the illness experience. The purpose of this randomized clinical trial is to evaluate the efficacy of a culturally sensitive family-based intervention program developed for African American families coping with solid tumor parental cancer using an intention-to-treat approach. Primary outcome is adolescent depressive symptoms at end of treatment. METHODS:A sample of 172 African American families will be enrolled from two diverse oncology centers (Helen Graham Cancer Center in Newark, DE, and Kimmel Cancer Center in Philadelphia, PA). Eligible families will be randomized either to a 5-session intervention Families Fighting Cancer Together (FFCT) or a 5-session parent-only psycho-educational (PED) program. Assessments will occur at weeks 0 (baseline), 8 (end-of-treatment), 24, and 52. DISCUSSION:Treatments to help African American adolescents cope with the impact of parental cancer are scarce and urgently needed. If successful, this proposed research will change the nature of intervention support options available to African Americans, who are overrepresented and underserved by existing services or programs. TRIAL REGISTRATION:This project is registered with ClinicalTrials.gov (Protocol #: NCT03567330).

SUBMITTER: McKinney NS

PROVIDER: S-EPMC6245616 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Study protocol: a randomized control trial of African American families fighting parental cancer together.

McKinney Nicole S NS Virtue Shannon S Lewis Frances Marcus FM Willis Alliric I AI Pettyjohn Tanisha T Harmon La-Rhonda LR Davey Adam A

BMC cancer 20181120 1

<h4>Background</h4>African American adults experience a disproportionate burden and increased mortality for most solid tumor cancers and their adolescent children are negatively impacted by the illness experience. The purpose of this randomized clinical trial is to evaluate the efficacy of a culturally sensitive family-based intervention program developed for African American families coping with solid tumor parental cancer using an intention-to-treat approach. Primary outcome is adolescent depr ...[more]

PMID: 30453906

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Project description:BackgroundAlthough weight loss is an important primary outcome in obesity interventions, family-based interventions may have cascading ripple effects that extend to other aspects of health and well-being. Identifying these secondary benefits may be useful for understanding how to best engage underserved African American families in weight loss. The present research examines whether African American adolescents and parents perceive secondary benefits from participating in a family-based weight-loss intervention, including secondary health, social, or cognitive benefits.MethodsQualitative data were obtained from families participating in the group-based intervention of the Families Improving Together (FIT) for Weight Loss trial. During the final week of the face-to-face motivational and family-based intervention program, families completed a guided open-ended group discussion about changes they experienced from participating (14 groups, N = 41 adolescents and 41 parents). Sessions were audiotaped, transcribed, and coded by independent pairs of raters using both inductive and deductive approaches. Guided by the multi-theoretical framework for the FIT trial, some themes were determined prior to coding using a deductive approach, including: (a) health outcomes (e.g., monitoring strategies for diet and physical activity), (b) social outcomes (e.g., involvement in family support, group support, autonomy support, family bonding, positive communication) and (c) cognitive outcomes (e.g., expression of self-confidence through self-efficacy, self-regulation, establishment of long-term goals). In addition to these pre-determined themes, the coding process included an inductive assessment, allowing for unexpected themes to surface as well around positive self-talk, relapse prevention, and monitoring strategies for different types of weight-related behaviors.ResultsAcross both adolescents and parents, the cognitive outcomes were the most frequently discussed outcomes, including self-regulation, monitoring strategies for diet, establishing long-term goals, and ultimate relapse prevention. Parents made a greater number of comments about the social outcomes, including family support, group support, self-efficacy, and family connectedness, whereas adolescents made a greater number of comments about positive family communication.ConclusionsThe results provide preliminary support for the positive secondary effects of weight loss programs on improving both cognitive and social well-being in underserved African American adolescents.Trial registrationClinicalTrials.gov # NCT01796067. https://clinicaltrials.gov/ct2/show/NCT01796067?term=NCT01796067&rank=1 The trial was registered on February 21, 2013 and the first participant was enrolled July 12, 2013.

Project description:BackgroundAmong adults in the United States, asthma prevalence is disproportionately high among African American women; this group also experiences the highest levels of asthma-linked mortality and asthma-related health care utilization. Factors linked to biological sex (e.g., hormonal fluctuations), gender roles (e.g., exposure to certain triggers) and race (e.g., inadequate access to care) all contribute to the excess asthma burden in this group, and also shape the context within which African American women manage their condition. No prior interventions for improving asthma self-management have specifically targeted this vulnerable group of asthma patients. The current study aims to evaluate the efficacy of a culturally- and gender-relevant asthma-management intervention among African American women.Methods/designA randomized controlled trial will be used to compare a five-session asthma-management intervention with usual care. This intervention is delivered over the telephone by a trained health educator. Intervention content is informed by the principles of self-regulation for disease management, and all program activities and materials are designed to be responsive to the specific needs of African American women. We will recruit 420 female participants who self-identify as African American, and who have seen a clinician for persistent asthma in the last year. Half of these will receive the intervention. The primary outcomes, upon which the target sample size is based, are number of asthma-related emergency department visits and overnight hospitalizations in the last 12 months. We will also assess the effect of the intervention on asthma symptoms and asthma-related quality of life. Data will be collected via telephone survey and medical record review at baseline, and 12 and 24 months from baseline.DiscussionWe seek to decrease asthma-related health care utilization and improve asthma-related quality of life in African American women with asthma, by offering them a culturally- and gender-relevant program to enhance asthma management. The results of this study will provide important information about the feasibility and value of this program in helping to address persistent racial and gender disparities in asthma outcomes.Trial registrationClinicalTrials.gov: NCT01117805.

Project description:BackgroundEffective hypertension self-management interventions are needed for socially disadvantaged African Americans, who have poorer blood pressure (BP) control compared to others.ObjectiveWe studied the incremental effectiveness of contextually adapted hypertension self-management interventions among socially disadvantaged African Americans.DesignRandomized comparative effectiveness trial.ParticipantsOne hundred fifty-nine African Americans at an urban primary care clinic.InterventionsParticipants were randomly assigned to receive (1) a community health worker ("CHW") intervention, including the provision of a home BP monitor; (2) the CHW plus additional training in shared decision-making skills ("DoMyPART"); or (3) the CHW plus additional training in self-management problem-solving ("Problem Solving").Main measuresWe assessed group differences in BP control (systolic BP (SBP) < 140 mm Hg and diastolic BP (DBP) < 90 mmHg), over 12 months using generalized linear mixed models. We also assessed changes in SBP and DBP and participants' BP self-monitoring frequency, clinic visit patient-centeredness (i.e., extent of patient-physician discussions focused on patient emotional and psychosocial concerns), hypertension self-management behaviors, and self-efficacy.Key resultsBP control improved in all groups from baseline (36%) to 12 months (52%) with significant declines in SBP (estimated mean [95% CI] - 9.1 [- 15.1, - 3.1], - 7.4 [- 13.4, - 1.4], and - 11.3 [- 17.2, - 5.3] mmHg) and DBP (- 4.8 [- 8.3, - 1.3], - 4.0 [- 7.5, - 0.5], and - 5.4 [- 8.8, - 1.9] mmHg) for CHW, DoMyPART, and Problem Solving, respectively). There were no group differences in BP outcomes, BP self-monitor use, or clinic visit patient-centeredness. The Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 18.7 [4.0, 87.3]) and self-efficacy scores (OR [95% CI] 4.7 [1.5, 14.9]) at 12 months compared to baseline, while other groups did not. Compared to DoMyPART, the Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 5.7 [1.3, 25.5]) at 12 months.ConclusionA context-adapted CHW intervention was correlated with improvements in BP control among socially disadvantaged African Americans. However, it is not clear whether improvements were the result of this intervention. Neither the addition of shared decision-making nor problem-solving self-management training to the CHW intervention further improved BP control.Trial registryClinicalTrials.gov Identifier: NCT01902719.

Project description:BackgroundCompared with white persons, African Americans have a greater incidence of diabetes, decreased control, and higher rates of microvascular complications. A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes.ObjectiveTo determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their hemoglobin A(1c) (HbA(1c)) levels.DesignA 6-month randomized, controlled trial. (ClinicalTrials.gov registration number: NCT01125956)SettingPhiladelphia Veterans Affairs Medical Center.PatientsAfrican American veterans aged 50 to 70 years with persistently poor diabetes control.Intervention118 patients were randomly assigned to 1 of 3 groups: usual care, a peer mentoring group, and a financial incentives group. Usual care patients were notified of their starting HbA(1c) level and recommended goals for HbA(1c). Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control (HbA(1c) level ≤7.5%). The mentor was asked to talk with the patient at least once per week. Peer mentors were matched by race, sex, and age. Patients in the financial incentive group could earn $100 by decreasing their HbA(1c) level by 1% and $200 by decreasing it by 2% or to an HbA(1c) level of 6.5%.MeasurementsChange in HbA(1c) level at 6 months.ResultsMentors and mentees talked the most in the first month (mean calls, 4; range, 0 to 30), but calls decreased to a mean of 2 calls (range, 0 to 10) by the sixth month. Levels of HbA(1c) decreased from 9.9% to 9.8% in the control group, from 9.8% to 8.7% in the peer mentor group, and from 9.5% to 9.1% in the financial incentive group. Mean change in HbA(1c) level from baseline to 6 months relative to control was -1.07% (95% CI, -1.84% to -0.31%) in the peer mentor group and -0.45% (CI, -1.23% to 0.32%) in the financial incentive group.LimitationThe study included only veterans and lasted only 6 months.ConclusionPeer mentorship improved glucose control in a cohort of African American veterans with diabetes.Primary funding sourceNational Institute on Aging Roybal Center.

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Study protocol: a randomized control trial of African American families fighting parental cancer together.

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Study protocol: a randomized control trial of African American families fighting parental cancer together.

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