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Psychosocial Intervention

iCALM for Advanced Cancer (iCALM Trial)

N/A

Recruiting

Led By Sarah Hales, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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]

not cognitively impaired

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

iCALM Trial Summary

This trial is testing an online intervention called iCALM to see if it can help reduce psychological distress and improve well-being in people with advanced cancer.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic cancer, expected to live 12-18 months. They must read/write English, commit to online sessions, have internet access, and be treated at Princess Margaret Cancer Centre. Excluded are those with cognitive impairment or in psychotherapy.Check my eligibility

What is being tested?

The study tests an online program called iCALM designed to help people with advanced cancer cope better emotionally. It's based on a successful face-to-face therapy that has helped reduce depression among patients facing serious illness.See study design

What are the potential side effects?

Since iCALM is a psychological intervention rather than a drug, it may not have typical side effects. However, participants might experience emotional discomfort discussing their condition.

iCALM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced cancer and am expected to live 12-18 months.

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I am not experiencing any cognitive impairments.

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I am 18 years old or older.

iCALM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Health Questionnaire-9

Secondary outcome measures

Death and Dying Distress Scale

Experiences in Close Relationships Inventory Modified Short Form Version

Quality of Life at the End of Life-Cancer Scale

Other outcome measures

Attitudes towards Psychological Online Interventions

Clinical Evaluation Questionnaire-Internet

Customer Satisfaction Questionnaire

+2 more

iCALM Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iCALM Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Care as usualActive Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,954 Total Patients Enrolled

University of UlmOTHER

182 Previous Clinical Trials

66,765 Total Patients Enrolled

Sarah Hales, MDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

iCALM (Psychosocial Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04757155 — N/A

Cancer Research Study Groups: iCALM Intervention Group, Care as usual

Cancer Clinical Trial 2023: iCALM Highlights & Side Effects. Trial Name: NCT04757155 — N/A

iCALM (Psychosocial Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04757155 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining in this medical experiment?

"According to the clinicaltrials.gov website, this research endeavour is still looking for patients and was initially posted on October 13th 2021 with a last update occurring two weeks later on October 27th."

Answered by AI

How many participants can join the research study?

"Affirmative. The clinicaltrials.gov website indicates that this medical study, which was created on October 13th 2021, is actively seeking participants. 50 patients need to be enrolled at 1 centre for the experiment to continue."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Phase II RCT of an Internet-adaptation of Managing Cancer and Living Meaningfully (iCALM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04757155.