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Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial

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Abstract

Purpose

To conduct a secondary analysis focused on health-related quality of life (HRQOL) among caregivers engaged in a 12-week complementary therapy sequential multiple assignment randomized trial (SMART) of reflexology and/or meditative practices (MP), to manage cancer patients’ symptoms.

Methods

In this SMART, patient-caregiver dyads were initially randomized to 4 weeks of caregiver-delivered reflexology for the patient (N = 150), MP with the patient (N = 150), or control (N = 47). After 4 weeks, dyads with patients not improving on fatigue (non-responders, n = 69 to reflexology and n = 57 to MP) were re-randomized to continue the same therapy or add the other therapy for an additional 4 weeks. Week-12 caregiver HRQOL was measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 and the Caregiver Reaction Assessment Tool (CRAT) for caregiver burden; scores were analyzed using general linear models.

Results

In the comparison of 4 adaptive intervention sequences: reflexology for 8 weeks, reflexology for 4 weeks followed by MP for 4 weeks if no response to reflexology, MP for 8 weeks, and MP for 4 weeks followed by reflexology for 4 weeks if no response to MP, there were no differences in PROMIS-29 scores. However, CRAT domains of impact on schedule, family support, and finances worsened when adding reflexology after the first 4 weeks of MP. The CRAT domain of health worsened by adding either intervention compared to continuing the same one.

Conclusions

Clinicians should be aware that caregiver engagement in more than one complementary therapy may increase caregiver burden in some domains but not affect other HRQOL domains.

Trial registration

ClinicalTrials.gov Identifier: NCT 02759146

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Availability of data and material

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

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Acknowledgements

The authors would like to thank study’s participants; this work would not have been possible without their participation.

Funding

The project was supported by the National Institution of Health (NIH), grant R01 CA193706.

Author information

Authors and Affiliations

  1. College of Nursing, Michigan State University, 1355 Bogue Street, East Lansing, MI, 48824, USA

    Kanjana Thana, Rebecca Lehto & Gwen Wyatt

  2. Faculty of Nursing, Chiang Mai University, 110/406 Inthawaroros Road, Chiang Mai, 50200, Thailand

    Kanjana Thana

  3. Department of Psychiatry, Michigan State University, 909 Wilson Road, Room 32, East Lansing, MI, 48824, USA

    Alla Sikorskii

  4. Department of Statistics and Probability, Michigan State University, 619 Red Cedar Road, East Lansing, MI, 48824, USA

    Pratim Guhaniyogi

  5. Department of Epidemiology and Biostatistics, Michigan State University, 909 Wilson Road, East Lansing, MI, 48824, USA

    Sarah Brewer

  6. Northwestern University Feinberg School of Medicine, Evanston, IL, 60208, USA

    David Victorson

  7. University of Arizona College of Nursing, 1305 N. Martin Ave, PO Box 210203, Tucson, AZ, 85721, USA

    Thaddeus Pace & Terry Badger

Authors
  1. Kanjana Thana
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  2. Alla Sikorskii
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  3. Rebecca Lehto
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  4. Pratim Guhaniyogi
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  9. Gwen Wyatt
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by KT and PG, supervised directly by GW and AS. The first draft of the manuscript was written by KT, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Gwen Wyatt.

Ethics declarations

Ethics approval

The study was approved by the IRB of Michigan State University. The identity of the participants was kept confidential.

Consent to participate

This study is a secondary analysis of the previous study “Using SMART Design to Improve Symptom Management Among Cancer Patients.” Informed consent for participation in this study was obtained from each dyad before the conduct of previous study.

Consent for publication

This study is a secondary analysis of the previous study. Informed consent was obtained from each dyad for the use of their anonymized data for publication purposes before the conduct of previous study.

Conflict of interest

The authors declare no competing interests.

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Thana, K., Sikorskii, A., Lehto, R. et al. Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial. Support Care Cancer 30, 5891–5902 (2022). https://doi.org/10.1007/s00520-022-07012-7

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  • DOI: https://doi.org/10.1007/s00520-022-07012-7

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