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Articles

A multi-center randomized controlled trial to reduce unmet needs, depression, and anxiety among hematological cancer patients and their support persons

, PhD, MBBSORCID Icon, , PhD, BPsyc (Hons)ORCID Icon, , BPsyc (Hons)ORCID Icon, , PhD, M. Psychology (Clin), BPsyc (Hons)ORCID Icon, , PhD, B. Math (Hons)ORCID Icon, , PhD, Dip. Ed, DCSE, B. MathORCID Icon, , MBBS, PhD, FRACP, FRCPAORCID Icon, , MBBS, FRACP, FRCPAORCID Icon, , MBBS, FRACP, FRCPAORCID Icon, , MBBS, MD, FRCP, FRCPA, FASCP, FACP, MClinEpidORCID Icon, , GradCert. Onc. Nurs., BHS (Nurs), DHS (Nurs)ORCID Icon, , PhD, BS (Hons)ORCID Icon, , PhD, BA (Hons)ORCID Icon & , PhD, B. Math, GradDip Med. Stat., Dip. EdORCID Icon show all
 

Abstract

Purpose: Individuals diagnosed with a high-grade hematological malignancy are at high risk for psychosocial distress. This study aimed to examine the effectiveness of a web-based information tool and nurse delivered telephone support in reducing: (i) unmet information needs; (ii) depression; and (iii) anxiety, among hematological cancer patients and their support persons (SPs).

Methods: Patients with a new diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Burkitt lymphoma, or lymphoblastic lymphoma and their SPs were enrolled in a prospective multi-site randomized trial. Participants received either access to an online information tool and telephone support from a hematology nurse, or usual care. Outcome data were collected 2, 4, 8, and 12 weeks post-recruitment. The primary endpoint was unmet information needs.

Results: Data from 60 patients and 15 SPs were included in the analysis. There were no statistically significant differences in unmet information needs, depression or anxiety between intervention and control groups for patients. Patients in both groups demonstrated a decrease in information needs over the intervention period. Post hoc analyses revealed that patients who did not achieve remission with the first cycle of treatment experienced increased anxiety from 4 weeks until the end of the study (p = 0.008).

Conclusions: A web-based information tool and nurse delivered telephone support did not reduce unmet information needs, depression or anxiety among hematological cancer patients, however this finding is inconclusive given the low power of the study.

Implications for Psychosocial Providers or Policy: Patients who do not achieve remission are at high risk of anxiety, and may benefit from targeted psychological intervention.

Author contributions

All authors were involved in design of the clinical trial. RSF, WS, AW, FH, MC, CDE, and CP obtained study funding. WS, JB, RW, RSF, and AW developed the intervention. WS, JB, RW, and RSF oversaw overall implementation of the trial. WS, CB, SR, CT, AE, and JG oversaw implementation of the trial at specific sites. FH developed the underlying software for the web-based tool. CO conducted data analysis. All authors have contributed to, read, and approved the final manuscript.

Compliance with ethical standards

Conflict of Interest: The authors declare that they have no conflict of interest.

Ethical 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. Approval was also provided by the local research governance committees of each participating hospital.

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

Acknowledgements

The authors would like to thank the members of the Expert Advisory Groups for assistance with development of the intervention, participating treatment centers for assisting with recruitment of patients, our volunteers who assisted with intervention implementation and data collection, Dr Breanne Hobden for assistance with trial management and data collection, and Dr David Paul for assistance with development of the web-based tool. We would like to thank Dr Andrew Wei and Associate Professor Mariko Carey for their advice with study design and intervention development. We would also like to thank the Cancer Council NSW, Leukemia Foundation, and MacMillan Cancer Support UK for permission to use and adapt information resources.

Additional information

Funding

This trial was funded by a Cancer Institute New South Wales Translation Program Grant (10/THS/2-14). Dr Jamie Bryant was supported by an Australian Research Council Post-Doctoral Industry Fellowship. Dr Anoop K Enjeti is the recipient of a Hunter New England Local Health District/NSW Health Pathology/Calvary Mater Newcastle Translational Research Fellowship. Dr Flora Tzelepis was supported by a Leukemia Foundation of Australia and Cure Cancer Australia Foundation Post-Doctoral Research Fellowship. Prof Christine Paul was supported by a National Health and Medical Research Council Career Development Fellowship (APP1061335).

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