Phase II RCT of an Internet-adaptation of Managing Cancer and Living Meaningfully (iCALM)

Titre officiel

The Online Adaptation of Managing Cancer and Living Meaningfully (iCALM): A Phase II Randomized Controlled Trial

Sommaire:

iCALM est une adaptation en ligne d’une brève intervention psychosociale individuelle du nom de « Managing Cancer and Living Meaningfully (CALM) » (gérer le cancer et vivre en paix), destinée aux patients atteints d’un cancer métastatique avancé. Il a été démontré que cet outil réduit ou prévient la dépression dans cette population. Cette étude a pour but d’évaluer l’outil iCALM quant à son acceptabilité, à sa faisabilité et à son efficacité préliminaire à réduire ou prévenir la détresse psychologique et à améliorer le bien-être psychologique des patients atteints d’un cancer avancé.

Description de l'essai

Primary Outcome:

• Patient Health Questionnaire-9

Secondary Outcome:

• Quality of Life at the End of Life-Cancer Scale
• Death and Dying Distress Scale
• Experiences in Close Relationships Inventory Modified Short Form Version

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.

Voir cet essai sur ClinicalTrials.gov