Clinical trial NCT04757155: Phase II RCT of an Internet-adaptation of Managing Cancer and Living Meaningfully (iCALM)
Official title: The Online Adaptation of Managing Cancer and Living Meaningfully (iCALM): A Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of Ulm
First posted: 2021-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: iCALM is an online adaptation of a brief, individual, psychosocial intervention called Managing Cancer and Living Meaningfully (CALM) in patients with advanced and metastatic cancer. CALM has been shown to reduce or prevent depression in this population. The purpose of this study is to evaluate iCALM with regards to its acceptability, feasibility and preliminary efficacy in reducing or preventing psychological distress and improving psychological well-being in patients with advanced cancer.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age;
* ability to read and write in English;
* able to access the internet.
* not cognitively impaired;
* able to commit to the required online sessions; and
* patients at Princess Margaret Cancer Centre with a confirmed or working diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months \[stage III or IV lung cancer, any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer or other stage IV (metastatic) GI cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological (GYNE) cancer; and stage IV breast, genitourinary (GU), sarcoma, melanoma or endocrine cancers\].

Exclusion Criteria:

* Inability to pass the cognitive screening test (Short Orientation-Memory-Concentration Test (SOMC) score \<20, Katzman et al., 1983); and
* actively receiving a structured or semi-structured psychotherapy at Princess Margaret Cancer Centre

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary outcomes:
measure: Quality of Life at the End of Life-Cancer Scale
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Death and Dying Distress Scale
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
measure: Experiences in Close Relationships Inventory Modified Short Form Version
timeFrame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Other outcomes:
measure: Qualitative Interview
timeFrame: Through study completion, an average of 1 year
measure: Attitudes towards Psychological Online Interventions
timeFrame: 4 weeks, 8 weeks, and 12 weeks
measure: Customer Satisfaction Questionnaire
timeFrame: 4 weeks, 8 weeks, and 12 weeks
measure: Clinical Evaluation Questionnaire-Internet
timeFrame: 4 weeks, 8 weeks, and 12 weeks
measure: Working Alliance Inventory for guided internet interventions
timeFrame: 4 weeks, 8 weeks, and 12 weeks
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Gary Rodin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Sarah Hales, MD
role: PRINCIPAL_INVESTIGATOR
References: