NCT07083245

Brief Summary

This study seeks to examine the impact of a psychosocial intervention offered by the Coda Comfort Crew, which entails providing conversational support, parallel play, material support through gift bags and more on anxiety and depression, and on distress experienced by patients undergoing chemotherapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 16, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

CancerPsychosocialAnxietyDepressiondistress

Outcome Measures

Primary Outcomes (2)

  • Distress

    A checklist of things that might evoke unpleasant experiences of a mental, physical, social, or spiritual nature, as well as a 1-10 scale of overall distress.

    3 months

  • HADS

    Hospital anxiety and depression scale scores

    3 months

Study Arms (1)

Psychosocial support group

EXPERIMENTAL

This arm will receive treatment through the form of the Coda Comfort Crews intervention, including material and psychosocial support. This will be done through material gifts, watching movies and playing board games as well as conversations together during chemotherapy treatments.

Behavioral: Psychosocial care

Interventions

Psychosocial support to chemotherapy patients during their treatment sessions through conversations, board games, movies, and gift baskets

Psychosocial support group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥ 18 years old)
  • Diagnosed with cancer and undergoing chemotherapy at the Gatineau Cancer Center during the intervention and study period
  • Able to understand and provide informed consent
  • Sufficient understanding of French or English

You may not qualify if:

  • Major cognitive impairment preventing understanding
  • Severe medical or psychiatric comorbidities limiting participation
  • Minors (\< 18 years old)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsAnxiety DisordersDepression

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

September 1, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share