CancerCCCNCT07083245
Coda Comfort Crew Pilot Project: Assessing and Addressing the Psychosocial Needs of Chemotherapy Patients With the Gatineau Cancer Center
A study testing Psychosocial care in people with Cancer, run by Coda Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Psychosocial care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major cognitive impairment preventing understanding
- Severe medical or psychiatric comorbidities limiting participation
- Minors (< 18 years old)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Cancer
- Being tested
- Psychosocial care
- Keywords
- Cancer, Psychosocial, Anxiety, Depression, distress
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial careBehavioural
Psychosocial support to chemotherapy patients during their treatment sessions through conversations, board games, movies, and gift baskets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychosocial care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
HADS
Hospital anxiety and depression scale scores
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coda Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Shaw, Coda Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083245
- Sponsor's protocol ID
- codacomfortcrewpilotstudy
- Acronym
- CCC
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coda Comfort Crew Pilot Project: Assessing and Addressing the Psychosocial Needs of Chemotherapy Patients With the Gatineau Cancer Center
- ClinicalTrials.gov ID
- NCT07083245
- Acronym / sponsor ID
- CCC / codacomfortcrewpilotstudy
- Conditions
- Cancer
- Keywords
- Cancer, Psychosocial, Anxiety, Depression, distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Coda FoundationUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial support group | Experimental | Behavioral: Psychosocial careThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Major cognitive impairment preventing understanding
- Severe medical or psychiatric comorbidities limiting participation
- Minors (< 18 years old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial carePsychosocial support to chemotherapy patients during their treatment sessions through conversations, board games, movies, and gift baskets | Behavioural | Psychosocial support group |
Primary outcome
Distress
Time frame: 3 months
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.
HADS
Time frame: 3 months
Hospital anxiety and depression scale scores
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial care in people with Cancer, run by Coda Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick D Shaw (438-397-2188, shap5280@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.