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

NCT04757155 | Active Not Recruiting

• 1 other identifier: 19-5167
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of Life at the End of Life-Cancer Scale

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Death and Dying Distress Scale

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Experiences in Close Relationships Inventory Modified Short Form Version

  Baseline, 4 weeks, 8 weeks, and 12 weeks

Other Outcomes (5)

• Qualitative Interview

  Through study completion, an average of 1 year

• Attitudes towards Psychological Online Interventions

  4 weeks, 8 weeks, and 12 weeks

• Customer Satisfaction Questionnaire

  4 weeks, 8 weeks, and 12 weeks

Study Arms (2)

iCALM Intervention Group

EXPERIMENTAL

iCALM is a brief, online psychotherapeutic intervention for patients with advanced and metastatic cancer. It consists of one introductory module and four therapeutic modules composed of written psychoeducational material, videos, and exercises. The intervention is designed to be completed in 9 weeks.

Behavioral: Internet Adaptation of Managing Cancer and Living Meaningfully (iCALM)

Care as usual

NO INTERVENTION

Participants in the usual care group (UC) will receive routine care. At Princess Margaret Cancer Centre, routine care includes a referral to Psychiatry, Psychology, or Social Work, based on patients' needs.

Interventions

Internet Adaptation of Managing Cancer and Living Meaningfully (iCALM) BEHAVIORAL

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

iCALM Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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 \[stage III or IV lung cancer, any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer or other stage IV (metastatic) GI cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological (GYNE) cancer; and stage IV breast, genitourinary (GU), sarcoma, melanoma or endocrine cancers\].

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Ulm: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Study Officials

• Gary Rodin, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Sarah Hales, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 17, 2021
• Study Start: October 13, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)