Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

University of Ulm

Conditions:

Advanced Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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 sho...

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 a...

Eligibility Criteria

Inclusion

  • ≥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

  • 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

Key Trial Info

Start Date :

October 13 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04757155

Start Date

October 13 2021

End Date

December 1 2025

Last Update

July 17 2025

Active Locations (1)

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

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