Phase II RCT of an Internet-adaptation of Managing Cancer and Living Meaningfully (iCALM)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients with advanced cancer are at risk for depression due to the disease and to side effects from its treatment. Depression in this population decreases quality of life and adherence to treatment and increases the risk of suicide. Psychotherapy can be effective to treat depression, but most patie...
Patients with advanced cancer are at risk for depression due to the disease and to side effects from its treatment. Depression in this population decreases quality of life and adherence to treatment and increases the risk of suicide. Psychotherapy can be effective to treat depression, but most patients affected by cancer and depression do not receive it, due to a lack of tailored therapies or trained clinicians in cancer treatment centres or in the community. To address this issue, we developed a novel 3-6 session psychotherapy intervention called Managing Cancer and Living Meaningfully (CALM) to prevent and treat depression in patients with advanced disease. In a large randomized controlled trial (RCT), we demonstrated that CALM reduces or prevents depression in these patients. However, since access to trained clinicians is limited, we will develop an online version of CALM, referred to as iCALM, and test its feasibility and preliminary efficacy. In the present study we will: i) adapt the CALM intervention to its online delivery; and ii) recruit 50 patients at the Princess Margaret Cancer Centre (PM), who will be randomized (25 patients per group) to receive either iCALM or usual care. Usual care patients will be offered iCALM at the end of the study on compassionate grounds. Questionnaires assessing intervention satisfaction, depression, death anxiety, and quality of life will be administered at recruitment and after 4, 8 and 12 weeks. Qualitative interviews will be conducted with patients and eCoaches to explore their experience of using iCALM.
Tracking Information
- NCT #
- NCT04757155
- Collaborators
- University of Ulm
- Investigators
- Principal Investigator: Gary Rodin, MD University Health Network, Toronto Principal Investigator: Sarah Hales, MD University Health Network, Toronto