Managing cancer and living meaningfully (CALM) in people with non-small cell lung cancer treated with novel therapies: a pilot study

Not Applicable

Active, not recruiting

• Conditions: non-small cell lung cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12623000987662
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-11
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 19

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[ post-intervention (immediately after completing the CALM intervention sessions), 3 months after baseline, and 6 months after baseline];Any change in death anxiety defined by a change score of 10% or more on the Death and Dying Distress Scale (DADDS).[ post-intervention (immediately after completing the CALM intervention sessions), 3 months after baseline, and 6 months after baseline];Any change in quality of life defined by a change score of 10% or more on the Functional Assessment Cancer Therapy - General (FACT-G).[ post-intervention (immediately after completing the CALM intervention sessions), 3 months after baseline, and 6 months after baseline]