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

Advanced Cancer Clinical Trial

— iCALM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757155
• Other study ID #: 19-5167
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: Gary Rodin, MD
• Phone: 4169644504
• Email: Gary.Rodin[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Behavioral:
• Internet Adaptation of Managing Cancer and Living Meaningfully (iCALM)
A online psychotherapy designed for patients with advanced and metastatic cancer.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	University of Ulm

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Interview	A qualitative study employing a grounded theory methodology	Through study completion, an average of 1 year
Other	Attitudes towards Psychological Online Interventions	A 16-item validated questionnaire that measures participants' acceptance towards POIs across four sub-scales: (1) skepticism and perception of risks, (2) confidence in effectiveness, (3) technologization threat (i.e., reluctance to receive psychological support through online interventions), and (4) accessibility and anonymity benefits of online interventions. Scores on each dimension may range from 0-20, and total scores may range from 0-80 with higher scores indicating greater acceptance towards POIs.This measure will be administered to participants randomized to the iCALM intervention at 4 weeks, 8 weeks and 12 weeks to assess change over time.	4 weeks, 8 weeks, and 12 weeks
Other	Customer Satisfaction Questionnaire	A 8-item scale measuring satisfaction with services and clinical care. Total scores may range from 0-32 with higher scores indicating greater satisfaction with services and clinical care. This measure will be administered to participants randomized to the iCALM intervention at 4 weeks, 8 weeks and 12 weeks to assess change over time.	4 weeks, 8 weeks, and 12 weeks
Other	Clinical Evaluation Questionnaire-Internet	A 14-item measure modified for this study to be applicable for the online delivery of CALM from the Clinical Evaluation Questionnaire (CEQ) and used to evaluate the extent to which patients felt supported by iCALM. Total scores range from 0-56 with higher scores indicating positive attitudes towards the online delivery of iCALM. This measure will be administered to participants randomized to the iCALM intervention at 4 weeks, 8 weeks and 12 weeks to assess change over time.	4 weeks, 8 weeks, and 12 weeks
Other	Working Alliance Inventory for guided internet interventions	A validated and reliable, 12-item measure used to capture alliance in guided Internet interventions. Total scores range from 0-60, with higher scores indicating more positive attitudes towards Internet interventions. This measure will be administered to participants randomized to the iCALM intervention at 4 weeks, 8 weeks and 12 weeks to assess change over time.	4 weeks, 8 weeks, and 12 weeks
Primary	Patient Health Questionnaire-9	A reliable and valid 9-item measure for depression. Total PHQ-9 scores may range from 0-27, with higher scores indicating more severe depressive symptoms. This measure will be administered to all participants at baseline, 4 weeks, 8 weeks and 12 weeks to assess change over time.	Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Quality of Life at the End of Life-Cancer Scale	A 14-item modified measure of the QUAL-E designed to assess the quality of life in patient populations nearing the end of life. Total scores may range from 0-70 with higher scores indicating better outcomes. This measure will be administered to all participants at baseline, 4 weeks, 8 weeks and 12 weeks to assess change over time.	Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Death and Dying Distress Scale	A validated 15-item scale measuring death anxiety in advanced cancer patients. Total DADDS scores may range from 0 to 75, with higher scores indicating greater death anxiety. This measure will be administered to all participants at baseline, 4 weeks, 8 weeks and 12 weeks to assess change over time.	Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary	Experiences in Close Relationships Inventory Modified Short Form Version	A reliable and valid 16-item version of the ECR-M-36 that assesses general attachment orientations to close others. It provides sub-scale scores assessing for attachment anxiety (i.e., fear of abandonment) and avoidance (i.e., defensive independence).Total scores on each dimension may range from 0-56 with higher scores indicating poor attachment insecurity. This measure will be administered to all participants at baseline, 4 weeks, 8 weeks and 12 weeks to assess change over time.	Baseline, 4 weeks, 8 weeks, and 12 weeks