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NCT Number: NCT04757155

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet Adaptation of Managing Cancer and Living Meaningfully (iCALM)

Behavioral

A online psychotherapy designed for patients with advanced and metastatic cancer.

Primary outcomes

  1. Patient Health Questionnaire-9

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    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.

Secondary outcomes

  1. Quality of Life at the End of Life-Cancer Scale

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    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.

  2. Death and Dying Distress Scale

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    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.

  3. Experiences in Close Relationships Inventory Modified Short Form Version

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    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.

Other outcomes

  1. Qualitative Interview

    Time frame: Through study completion, an average of 1 year

    A qualitative study employing a grounded theory methodology

  2. Attitudes towards Psychological Online Interventions

    Time frame: 4 weeks, 8 weeks, and 12 weeks

    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.

  3. Customer Satisfaction Questionnaire

    Time frame: 4 weeks, 8 weeks, and 12 weeks

    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. Clinical Evaluation Questionnaire-Internet

    Time frame: 4 weeks, 8 weeks, and 12 weeks

    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.

  5. Working Alliance Inventory for guided internet interventions

    Time frame: 4 weeks, 8 weeks, and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • University of Ulm

Registry information

Official study title

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

Acronym: iCALM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2021
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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