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Qol and Patients' Care

A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress

Bone Marrow Transplantation volume 50, pages 1110–1118 (2015)Cite this article

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Abstract

Caregivers of patients receiving allogeneic hematopoietic stem cell transplants (allo-HSCT) serve a pivotal role in patient care but experience high stress, anxiety and depression as a result. We theorized that stress management adapted for allo-HSCT caregivers would reduce distress compared with treatment as usual (TAU). Of 267 consecutive caregivers of allo-HSCT patients approached, 148 (mean=53.5 years, 75.7% female) were randomized to either psychosocial intervention (i=74) or TAU (n=74). Eight one-on-one stress management sessions delivered across the 100-day post-transplant period focused on understanding stress, changing role(s) as caregiver, cognitive behavioral stress management, pacing respiration and identifying social support. Primary outcomes included perceived stress (psychological) and salivary cortisol awakening response (CAR) (physiological). Randomized groups were not statistically different at baseline. Mixed models analysis of covariance (intent-to-treat) showed that intervention was associated with significantly lower caregiver stress 3 months post transplant (mean=20.0, 95% confidence interval (95% CI)=17.9–22.0) compared with TAU (mean=23.0, 95% CI=21.0–25.0) with an effect size (ES) of 0.39 (P=0.039). Secondary psychological outcomes, including depression and anxiety, were significantly reduced with ESs of 0.46 and 0.66, respectively. Caregiver CAR did not differ from non-caregiving controls at baseline and was unchanged by intervention. Despite significant caregiving burden, this psychosocial intervention significantly mitigated distress in allo-HSCT caregivers.

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Acknowledgements

The execution of this study was supported in full by the National Institutes of Health grant 1R01CA126971 while final preparation of this manuscript was supported partly by Patient Centered Outcomes Institute Contract CE-1304-6208. We are particularly grateful to the caregivers who not only give their time to the care of their patients but also accepted the added burden of participating in this study. We are also thankful to Dr Susan Lutgendorf in the development of the intervention. We also thank Africa Armendariz, Danielle Glenn, Robert Hill, Rita Ouseph and Maribel Perea for their contributions and support during the execution of this study.

Author Contributions

Dr Laudenslager and Dr Mikulich-Gilbertson had full access to all the data in blinded format and are responsible for its integrity, reporting to the DSMB and the accuracy of data analysis. Study concept and design: Kilbourn, Laudenslager, Mikulich-Gilbertson and Simoneau. Acquisition of data: Benitez, Natvig, Philips and Spradley. Analysis and interpretation of data: Laudenslager, Mikulich-Gilbertson, Kilbourn and McSweeney, Natvig, and Simoneau. Initial drafting of the manuscript: Laudenslager. Critical revision of the manuscript for important intellectual content: Benitez, Kilbourn, Laudenslager, McSweeney, Mikulich-Gilbertson, Philips, Simoneau and Spradley. Statistical analysis: Mikulich-Gilbertson. Obtained funding: Laudenslager and Simoneau. Administrative, technical or material support: Benitez, Laudenslager, McSweeney, Natvig and Simoneau.

Disclaimer

The funding sources had no role in the design and conduct of the study; in the collection, analysis and interpretation of the data; or in the preparation, review or approval of the manuscript.

Footnote

Regarding consistency of the information reported to ClinicalTrials.gov, a contract agency for the Protocol Coordinator for NCI's PDQ Cancer Clinical Trials Registry, Office of Communications and Education National Cancer Institute initially entered the trial information at ClinicalTrials.Gov using our approved IRB submission. We assumed this was the process for this new (2008) federal reporting requirement and believed we had performed our due diligence. We received a confirmation that the trial was recorded on 23 February 2009 although we had received a registration number prior to that date. We began recruitment only after that number was filed and we received approval by our IRB. When the responsibility for maintaining this information was shifted from NCI to the study site 3 years later, we realized that many errors were made by the contracting agency in the description of our protocol and we did our best to correct the errors. The first author takes full responsibility for errors in reporting at ClinicalTrials.gov. However, from a CONSORT perspective, a clear analysis plan was in place prior to breaking the blind. Although inadvertently omitted from the reported plan, we had planned two analysis stages: q(1) an intent-to-treat analysis of the 3-month intervention once all subjects had completed that assessment and the blind was broken and (2) a second analysis that would commence once all subjects completed their final 1-year evaluation time point.

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Authors and Affiliations

  1. Department of Psychiatry, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA

    M L Laudenslager, T L Simoneau, C Natvig, S Philips, P Benitez & S K Mikulich-Gilbertson

  2. Department of Psychology, Univerity of Colorado Denver, Denver, CO, USA

    K Kilbourn

  3. Presbyterian/St Luke’s Medical Center, Denver, CO, USA

    J Spradley & P McSweeney

  4. Colorado Blood Cancer Institute, Denver, CO, USA

    J Spradley & P McSweeney

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  1. M L Laudenslager
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Correspondence to M L Laudenslager.

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Additional information

A portion of this study was presented as a paper at the 10th Annual Meeting of the American Psychosocial Oncology Society, Huntington Beach, CA, USA by Simoneau TL, Kilbourn K, Mikulich-Gilbertson SK, Spradley J, Natvig C, McSweeney P, Laudenslager ML (February 2013). ‘Efficacy of a stress management intervention for allogeneic transplant caregivers’ and as a portion of the Norman Cousins Lectureship to the Psychoneuroimmunology Research Society, Stockholm Sweden by Mark L. Laudenslager, (June 2013), ‘Anatomy of an Illness: Control from a Caregiver’s perspective'.

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Laudenslager, M., Simoneau, T., Kilbourn, K. et al. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress. Bone Marrow Transplant 50, 1110–1118 (2015). https://doi.org/10.1038/bmt.2015.104

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