Evaluation of Managing Cancer and Living Meaningfully (CALM) in people with advanced non-small cell lung cancer treated with immunotherapies or targeted therapies: protocol for a single-arm, mixed-methods pilot study

Fiona Anne Lynch; Gary Rodin; Michael Jefford; Mary Duffy; Julia Lai-Kwon; Sarah Heynemann; Linda Mileshkin; Lisa Briggs; John Burke; Lilian Leigh; Tim Spelman; Maria Ftanou

doi:10.1136/bmjopen-2023-072322

Evaluation of Managing Cancer and Living Meaningfully (CALM) in people with advanced non-small cell lung cancer treated with immunotherapies or targeted therapies: protocol for a single-arm, mixed-methods pilot study

BMJ Open. 2023 Jul 31;13(7):e072322. doi: 10.1136/bmjopen-2023-072322.

Authors

Fiona Anne Lynch^{1

2}, Gary Rodin^{3

4}, Michael Jefford^{5

6

7

8}, Mary Duffy⁹, Julia Lai-Kwon⁵, Sarah Heynemann¹⁰, Linda Mileshkin^{5

8

9}, Lisa Briggs¹¹, John Burke¹¹, Lilian Leigh¹², Tim Spelman^{6

13}, Maria Ftanou^{14

15}

Affiliations

¹ Psychosocial Oncology Department, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia fiona.lynch@petermac.org.
² Psychology Department, Andrew Love Cancer Centre, Barwon Health, Geelong, Victoria, Australia.
³ Global Institute of Psychosocial, Palliative and End-of- Life Care (GIPPEC), Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
⁴ Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
⁵ Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
⁶ Department of Health Services Research and Implementation Science, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
⁷ Australian Cancer Survivorship Centre, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
⁸ Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia.
⁹ Lung Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
¹⁰ Department of Medical Oncology, St Vincent's Hospital Melbourne Pty Ltd, Fitzroy, Victoria, Australia.
¹¹ Patient Representative, Melbourne, Victoria, Australia.
¹² Patient Representative, Sydney, New South Wales, Australia.
¹³ Burnet Institute, Melbourne, Victoria, Australia.
¹⁴ Psychosocial Oncology Department, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
¹⁵ Melbourne School of Population and Global Health, University of Melbourne, Parkville, Victoria, Australia.

Abstract

Introduction: People with advanced non-small cell lung cancer (NSCLC) treated with immunotherapies (IT) or targeted therapies (TT) may have improved outcomes in a subset of people who respond, raising unique psychological concerns requiring specific attention. These include the need for people with prolonged survival to reframe their life plans and tolerate uncertainty related to treatment duration and prognosis. A brief intervention for people with advanced cancer, Managing Cancer and Living Meaningfully (CALM), could help people treated with IT or TT address these concerns. However, CALM has not been specifically evaluated in this population. This study aims to evaluate the acceptability and feasibility of CALM in people with advanced NSCLC treated with IT or TT and obtain preliminary evidence regarding its effectiveness in this population.

Methods and analysis: Twenty people with advanced NSCLC treated with IT or TT will be recruited from Peter MacCallum Cancer Centre, Melbourne, Australia. Participants will complete three to six sessions of CALM delivered over 3-6 months. A prospective, single-arm, mixed-methods pilot study will be conducted. Participants will complete outcome measures at baseline, post-intervention, 3 months and 6 months, including Patient Health Questionnaire, Death and Dying Distress Scale, Functional Assessment of Cancer Therapy General and Clinician Evaluation Questionnaire. The acceptability of CALM will be assessed using patient experiences surveys and qualitative interviews. Feasibility will be assessed by analysis of recruitment rates, treatment adherence and intervention delivery time.

Ethics and dissemination: Ethics approval has been granted by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/82047/PMCC). Participants with cancer will complete a signed consent form prior to participation, and carers and therapists will complete verbal consent. Results will be made available to funders, broader clinicians and researchers through conference presentations and publications. If CALM is found to be acceptable in this cohort, this will inform a potential phase 3 trial.

Keywords: Adult oncology; MENTAL HEALTH; ONCOLOGY; PSYCHIATRY.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Carcinoma, Non-Small-Cell Lung* / therapy
Feasibility Studies
Humans
Immunotherapy
Lung Neoplasms* / therapy
Pilot Projects
Prospective Studies