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Trial registered on ANZCTR


Registration number
ACTRN12623000987662
Ethics application status
Approved
Date submitted
14/06/2023
Date registered
11/09/2023
Date last updated
11/09/2023
Date data sharing statement initially provided
11/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing cancer and living meaningfully (CALM) in people with non-small cell lung cancer treated with novel therapies: a pilot study
Scientific title
Managing cancer and living meaningfully (CALM) in people with non-small cell lung cancer treated with novel therapies: a pilot study
Secondary ID [1] 309908 0
2147 - Grant ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-small cell lung cancer 330374 0
Condition category
Condition code
Cancer 327215 327215 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CALM is a semi-structured, manualized, individual psychotherapy designed for patients with advanced cancer and their loved ones. It shares features with manualized supportive-expressive, cognitive-existential, and meaning-centered group psychotherapies applied to patients with advanced and terminal disease. It was developed based on empirical data, clinical observations, and the theoretical foundations of relational, attachment and existential theory. It is informed by the founding team’s Canadian Institute of Health Research (CIHR)-funded longitudinal research aimed at identifying the antecedents and course of psychosocial morbidity in individuals with metastatic cancer.

CALM includes 3-6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3-6 months. Session frequency is according to participant preference and participant / therapist availability. Additional sessions may be offered if clinically indicated. The sessions cover 4 domains: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) sense of meaning and purpose; and 4) the future and mortality. All modules will be addressed with each patient, but the sequencing and time devoted to each domain will vary, based on the concerns that are most relevant to each patient. The patient’s caregiver (e.g., spouse, adult son/daughter, family member), or other persons accompanying the patient are encouraged to participate in one or more of the therapy sessions, as deemed appropriate by the patient and therapist. CALM can be delivered by specially trained therapists from a wide range of disciplines, including social work, nursing, psychiatry, psychology, and medicine.

CALM will be delivered in person, via telehealth (video-call), or phone call if no alternative is available. CALM therapists have been previously specifically trained in CALM completing a minimum of two days of CALM training unrelated to this study available to any practitioner delivered in person by CALM psychiatry developers Prof Gary Rodin and Prof Sarah Hales of Princess Margaret Cancer Centre. Therapists had also regularly attended CALM group supervision with Prof Rodin via video call at approximately monthly intervals. Therapists will include two clinical psychologists and one clinical nurse consultants. The patient’s CALM therapists will be provided with a copy of their measures completed at each timepoint whilst the therapist is still treating the patient including Patient Health Questionnaire (PHQ-9), Death and Dying Distress Scale (DADDS) and Functional Assessment of Cancer Therapy General (FACT-G). These are provided to inform clinical treatment and for therapists to discuss with patient as applicable.

Therapists will present each case a minimum of one occasion at supervision with Professor Gary Rodin, and optimally at the start and end of therapy, during which they will present a small segment of audio recording of a therapy session where available. Treatment fidelity will be assessed by 1) a review of supervisor-rated treatment fidelity using the CALM Treatment Integrity Measure (CTIM) completed after each supervisory session, 2) audio recording all sessions and then reviewing sections of therapy sessions during supervision to check compliance with protocols using the CTIM.
Intervention code [1] 326334 0
Treatment: Other
Intervention code [2] 326557 0
Lifestyle
Intervention code [3] 326558 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335092 0
Change scores will be calculated for participants who complete at least three sessions of CALM. Any change in depressive symptoms will be assessed using a change score of 5 points or more on the Patient Health Questionnaire (PHQ-9).
Timepoint [1] 335092 0
post-intervention (immediately after completing the CALM intervention sessions), 3 months after baseline, and 6 months after baseline
Primary outcome [2] 335093 0
Any change in death anxiety defined by a change score of 10% or more on the Death and Dying Distress Scale (DADDS).
Timepoint [2] 335093 0
post-intervention (immediately after completing the CALM intervention sessions), 3 months after baseline, and 6 months after baseline
Primary outcome [3] 335094 0
Any change in quality of life defined by a change score of 10% or more on the Functional Assessment Cancer Therapy - General (FACT-G).
Timepoint [3] 335094 0
post-intervention (immediately after completing the CALM intervention sessions), 3 months after baseline, and 6 months after baseline
Secondary outcome [1] 422983 0
Number of participants recruited over number of months
Timepoint [1] 422983 0
Assessed at the conclusion of the study.
Secondary outcome [2] 424695 0
Therapist's time to deliver the intervention according to analysis of the Case Report Forms where therapists complete the time spent per session.
Timepoint [2] 424695 0
Immediately after completion of the final CALM intervention session.
Secondary outcome [3] 424696 0
Compliance with post-intervention measures completion measured by the number and proportion of participants who completed the post-intervention measures.
Timepoint [3] 424696 0
Immediately after completion of the final CALM intervention session.
Secondary outcome [4] 424698 0
Uptake - proportion of people who consent and complete baseline measures out of the number of people offered the intervention. Collected using a screening log of participants consenting and declining.
Timepoint [4] 424698 0
Assessed at the conclusion of the study
Secondary outcome [5] 424699 0
Patient satisfaction according to a self-reported Patient Experiences Survey including patient satisfaction with the intervention, if they would recommend it, their subjective experience of improvements, and qualitative data on what they found helpful or unhelpful. Patients rate each item on a five point scale ranging from strongly disagree to strongly agree.
Timepoint [5] 424699 0
Immediately after completion of the final CALM intervention session.
Secondary outcome [6] 424700 0
Composite outcome of patient and carer experiences according to transcribed qualitative interview data from semi-structured one-on-one telehealth or phone interviews with a research team member.
Timepoint [6] 424700 0
Approximately one month after the final CALM intervention session.
Secondary outcome [7] 424701 0
Therapist perceptions of the acceptability of CALM for these participants according to a transcribed one-on-one semi-structured video interview conducted with a research assistant or honours student researcher.
Timepoint [7] 424701 0
Approximately one month after the therapist's final CALM intervention session.
Secondary outcome [8] 424704 0
Acceptability of the intervention will be assessed using the Clinician Evaluation Questionnaire.
Timepoint [8] 424704 0
At 3-months after baseline, 6-months after baseline, and immediately after completion of the final CALM intervention session.
Secondary outcome [9] 424706 0
Fidelity will be assessed using evaluation of the CALM Treatment Integrity Measure that will be completed by the CALM supervisor after each CALM supervision case presentation.
Timepoint [9] 424706 0
At completion of all CALM supervision presentations

Eligibility
Key inclusion criteria
at least 18 years old;
diagnosis of locally advanced NSCLC or metastatic NSCLC;
currently or previously receiving immunotherapy or targeted therapy and at least 6 months post initiation of IT (such as pembrolizumab, atezolizumab, nivolumab) or TT (such as TT directed at EGFR, ALK, ROS1, BRAF, MEK or RET) or combination chemotherapy/immunotherapy;
expected prognosis of at least 6 months (to allow for completion of therapy);
able to read and write in English.
able to commit to 3-6 sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
major communication difficulties;
cognitive impairment on the basis of a Short Orientation-Memory-Concentration Test (SOMCT) of 7 or more or indicated by the clinical team or medical file
patients currently receiving formal psychological therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to summarise demographic, clinical, feasibility data (including time measures), treatment details (modality; if carers were present) and responses to outcome measure questionnaires (count/percentage, mean/standard deviation, median/interquartile range as appropriate). Descriptive statistics will be reported for the full sample.



Change scores will be calculated for participants who complete at least three sessions of CALM. Participants who reported a reduction of 5+ points on the PHQ-9 will be summarised with a proportion of the sample and 95% confidence interval for the full sample and separately for participants with a baseline PHQ of 8 or more. The proportion and confidence interval will be reported for participants experiencing a 10% or more reduction on the DADDS, or 10% or more increase on the FACT-G. The number and proportion of the sample who have a remission in depressive symptoms of at least threshold severity (indicated by PHQ-9 of 8 or more points) in those participants with PHQ of 8 or more at baseline will be reported. Continuous variables will be compared using a paired samples t-tests or Wilcoxon signed-rank test as appropriate before and after the intervention and a Kazis effect size will be reported. These analyses are contingent on the project obtaining an appropriate sample size that may not be reached.



Data will be managed through REDCap and quantitative data analysed using SPSS (version 24) or Excel.



Free text items from the patient satisfaction surveys, and transcribed patient/therapist interviews will be analysed using summarising content analysis using NVivo software. A deductive content analysis approach will be used for coding data. Pre-defined categories will be formulated based on the research questions informing the study. Additional inductive codes will be identified from the survey responses.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
17/06/2022
Date of last participant enrolment
Anticipated
Actual
3/01/2023
Date of last data collection
Anticipated
6/10/2023
Actual
Sample size
Target
20
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24919 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 40570 0
3001 - Melbourne

Funding & Sponsors
Funding source category [1] 314090 0
Charities/Societies/Foundations
Name [1] 314090 0
Peter MacCallum Cancer Foundation
Country [1] 314090 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street Melbourne, 3000, Victoria, Australia
Country
Australia
Secondary sponsor category [1] 316004 0
None
Name [1] 316004 0
Address [1] 316004 0
Country [1] 316004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313227 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 313227 0
305 Grattan Street Melbourne, 3000, Victoria, Australia
Ethics committee country [1] 313227 0
Australia
Date submitted for ethics approval [1] 313227 0
06/12/2021
Approval date [1] 313227 0
08/05/2022
Ethics approval number [1] 313227 0
21/245

Summary
Brief summary
The overall aim of this study is to assess the acceptability, feasibility and potential impact of CALM in people with advanced NSCLC treated with novel therapies. The specific objectives of this project are to:

Assess the feasibility of the CALM intervention, outcome measures, and study design to guide the development of a Phase 3 RCT;

Explore the acceptability of CALM to patients with advanced NSCLC treated with novel therapies and to CALM therapists;

Provide preliminary evaluation of the potential impact of CALM in this population.

Study Design: A mixed methods design will be used for this pilot study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127418 0
Dr Fiona Lynch
Address 127418 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street Melbourne
3000, Victoria, Australia
Country 127418 0
Australia
Phone 127418 0
+61 385598236
Fax 127418 0
Email 127418 0
[email protected]
Contact person for public queries
Name 127419 0
Fiona Lynch
Address 127419 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street Melbourne
3000, Victoria, Australia
Country 127419 0
Australia
Phone 127419 0
+61 385598236
Fax 127419 0
Email 127419 0
[email protected]
Contact person for scientific queries
Name 127420 0
Fiona Lynch
Address 127420 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street Melbourne
3000, Victoria, Australia
Country 127420 0
Australia
Phone 127420 0
+61 385598236
Fax 127420 0
Email 127420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19446Study protocol  [email protected]
19447Ethical approval  [email protected]
19448Informed consent form  [email protected]
19449Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.