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Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial

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Abstract

Background

Managing Cancer and Living Meaningfully (CALM) is an evidence-based, brief, semi-structured psychotherapy designed to help patients with advanced cancer cope with the practical and profound challenges of their illness. However, no study to date has investigated its feasibility, acceptability, and preliminary effectiveness in adults with malignant glioma, despite the well-documented incidence of psychological distress in this vulnerable and underserved population.

Methods

Fourteen patients with glioma and elevated symptoms of depression and/or death anxiety enrolled in the trial: 83% glioblastoma, 75% female, Mage = 56 years (SD = 15.1; range = 27–81). Feasibility was assessed based on established metrics. Acceptability was measured by post-session surveys and post-intervention interviews. Preliminary intervention effects were explored using paired t-tests, comparing psychological distress at baseline and post-intervention.

Results

Of the 14 enrolled patients, 12 were evaluable. Nine completed the study (75% retention rate). Three patients withdrew due to substantial disease progression which affected their ability to participate. Participants reported high perceived benefit, and all recommended the program to others. Baseline to post-intervention assessments indicated reductions in death anxiety, generalized anxiety, and depression, and increases in spirituality. Quality of life and fear of cancer recurrence remained stable throughout the study period.

Conclusions

CALM appears feasible for use with adults with malignant glioma. Enrollment and retention rates were high and comparable to psychotherapy trials for patients with advanced cancer. High perceived benefit and reductions in symptoms of death anxiety, generalized anxiety, and depression were reported by participants. These findings are extremely encouraging and support further study of CALM in neuro-oncology.

Trial Registration Number

NCT04646213 registered on 11/27/2020.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

Thank you to all our patients who participated in CALM and to our neuro-oncology providers for referring for care.

Funding

Supported by Institutional Research Grant IRG-18–159-43 from the American Cancer Society. The project described was also supported by CTSA award No. KL2TR002648 from the National Center for Advancing Translational Sciences. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.

Author information

Authors and Affiliations

  1. Department of Neurology, School of Medicine, Virginia Commonwealth University, 1201 East Marshall St, Richmond, VA, 23298-0037, USA

    Ashlee R. Loughan, Sarah Ellen Braun & Mark Malkin

  2. Massey Cancer Center, Richmond, VA, USA

    Ashlee R. Loughan, Kelcie D. Willis, Sarah Ellen Braun, Autumn Lanoye, Mark Malkin & Leroy Thacker

  3. Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA

    Kelcie D. Willis, Alexandria E. Davies, Dace Svikis & Suzanne Mazzeo

  4. Princess Margaret Cancer Center, Toronto, Canada

    Gary Rodin

  5. Department of Health Behavior and Policy, Virginia Commonwealth University School of Medicine, Richmond, VA, USA

    Autumn Lanoye

  6. Department of Biostatistics, Virginia Commonwealth University School of Medicine, Richmond, VA, USA

    Leroy Thacker

  7. Division of Neuro-Oncology, Department of Neurology, Virginia Commonwealth University, School of Medicine, VCU Massey Cancer Center, 1201 East Marshall St, Richmond, VA, 23298-0037, USA

    Ashlee R. Loughan

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  1. Ashlee R. Loughan
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Contributions

Conceptualization: AL, PhD; methodology: AL, PhD; formal analysis and investigation: AL, PhD, KDW, MS, SB, PhD, AD, MS; writing—original draft preparation: AL, PhD; writing—review and editing: AL, PhD, KDW, MS, SB, PhD; GR MD, AL, PhD, AD, MS, DS PhD, SM PhD, MM MD, LT PhD; funding acquisition: AL, PhD; resources: AL, PhD; supervision: GR, MD, AL, PhD.

Corresponding author

Correspondence to Ashlee R. Loughan.

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Conflict of interest

The authors have no conflict of interests to disclose.

Informed consent

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

Ethical approval

Approval was obtained from the ethics committee of Virginia Commonwealth University and Massey Cancer Center (HM20020308). The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

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Loughan, A.R., Willis, K.D., Braun, S.E. et al. Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. J Neurooncol 157, 447–456 (2022). https://doi.org/10.1007/s11060-022-03988-8

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