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A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers

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Supportive Care in Cancer Aims and scope Submit manuscript

Abstract

Purpose

Mobile health interventions can improve patient care. We developed the Digital Supportive Care Awareness and Navigation (D-SCAN) application (app) to facilitate symptom monitoring and use/awareness of cancer supportive care resources. This study tested feasibility, usability/satisfaction, and preliminary efficacy of D-SCAN.

Methods

We randomized 50 patients with advanced cancer to receive the D-SCAN intervention or usual care; 10 caregivers also received D-SCAN. The primary feasibility outcome was determined by weekly symptom survey completion and end of study procedures. We assessed secondary outcomes including usability/satisfaction, awareness/use of supportive care resources, patient activation, and quality of life via various questionnaires including the Net Promoter Score (NPS), Patient Activation Measure (PAM-13), Functional Assessment of Cancer Therapy-General (FACT-G), and Caregiver Oncology Quality of Life (CarGOQOL) questionnaire.

Results

Seventy-six percent of intervention patients met feasibility criteria, exceeding our pre-determined threshold of 75%. Usability/satisfaction by NPS was high, at 14.3% and 12.5% for patients and caregivers, respectively. Intervention patient and caregiver resource awareness increased by a mean of 3.7 (p = 0.27) and 4.1 items, respectively. Supportive care resource utilization increased by a mean of 0.8 items for intervention patients (p = 0.70) and 0.6 for caregivers. PAM-13 increased by a mean of 1.6 for intervention patients (p = 0.65). FACT-G increased by a mean of 1.1 for intervention patients (p = 0.91), and CarGOQoL increased by a mean of 2.2 (p = 0.41).

Conclusion

D-SCAN is a feasible, usable, and satisfactory intervention for augmenting patient and caregiver supportive care. Further testing is necessary to formally assess D-SCAN’s efficacy and impact on patients and caregivers.

Clinical trial registration number. NCT03628794. Registered on August 14th, 2018.

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Data availability

Data has not been deposited to any central repository but can be made available upon request.

Code availability

All analyses were done using SAS v9.4 (SAS Institute, Cary, NC). Code can be made available upon request.

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Acknowledgements

We acknowledge Publicis Health for their work developing the D-SCAN mobile application. TLB and CM are currently employed by GlaxoSmithKline. We are thankful to the patients and families/caregivers who participated in this research.

Funding

This study was funded in part by AstraZeneca via a grant to the Duke Cancer Institute.

Author information

Authors and Affiliations

Authors

Contributions

Study conception and design: JC, CC, KH, AH, TWL, HM, CM, SP, TLB, SYZ.

Material preparation, data collection, and analysis: all authors.

Original draft: AM, AM, TWL.

Manuscript revision: all authors.

Funding acquisition: SP, TLW.

Corresponding author

Correspondence to Thomas W. LeBlanc.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Institutional Review Board of the Duke University School of Medicine (PRO00092123).

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Patients signed informed consent to participate in the study, which includes publishing deidentified data.

Conflict of interest

Researchers declare the following conflicts of interest: TWL reports personal fees for consulting or advisory boards from AbbVie, Agios/Servier, AstraZeneca, Astellas, CareVive, BMS/Celgene, Genentech, GSK, Pfizer, and Seattle Genetics; royalties from UpToDate; speakers bureau fees from Agios, AbbVie, and BMS/Celgene; grants and/or research contracts from the American Cancer Society, AstraZeneca, BMS, Jazz Pharmaceuticals, the NINR/NIH, and Seattle Genetics.

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Merz, A., Mohamed, A., Corbett, C. et al. A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers. Support Care Cancer 30, 7853–7861 (2022). https://doi.org/10.1007/s00520-022-07224-x

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  • DOI: https://doi.org/10.1007/s00520-022-07224-x

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