Lung Cancer Non-Small Cell Cancer (NSCLC)NCT07548788
A Lay Navigation Intervention for Patients With Lung Cancer
A study testing Care & Connect in people with Lung Cancer Non-Small Cell Cancer (NSCLC) and Lung Cancer Small Cell Lung Cancer (SCLC), run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Patient Navigation
- What is being tested?
- Care & Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to 1 Dec 2027
- 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
- Patient with diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) of any stage
- Age ≥ 18
- Have completed their first medical appointment at the Medical Oncology Lung Cancer Clinic at Princess Margaret Cancer Centre (PM), University Health Network
- Cognitive capacity to consent and complete questionnaires
Who cannot join
- Behavioural safety alert on medical record that would make their participation in Care \& Connect inappropriate
- Enrolment in another navigation study within University Health Network
- Patients who come to PM for a clinical trial visit
- Inability to communicate and read in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Coordinator contact
Canada1 site
Princess Margaret Cancer Center, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: Feasibility and Acceptability of the Care and Connect Program for Patients With Lung Cancer
Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Studies have consistently found that patients with cancer have a high number of unmet needs, including psychological, physical, and informational. Navigation programs represent a potentially promising, equitable, and cost-effective approach to address the unmet needs of patients with lung cancer, but there is limited evidence about their effectiveness in patients with lung cancer. The investigators developed and have implemented a volunteer lay navigator program, Care and Connect (C\&C), which aims to proactively reduce distress in patients, provide information and support, and increase access to treatment and supportive care resources. The proposed pilot randomized controlled trial (RCT) project plans to 1) assess the feasibility and acceptability of referral to C\&C and, 2) examine the preliminary effectiveness of C\&C.
Methods: The current study is a 2-arm, parallel group, mixed methods, pilot RCT with a 1:1 allocation ratio and 3 timepoints: baseline (T0), 3 months (T1), 6 months (T2). It is designed to test the trial feasibility and acceptability of the C\&C intervention in patients with lung cancer. In total, 50 participants will be randomized to receive the C\&C intervention or usual care only (25 per arm). At each timepoint, data will be collected on participants' access to psychosocial (PSO) services, psychological wellbeing, and satisfaction with care through participant medical record and a survey. To gain additional insights regarding the acceptability, feasibility, and impact of C\&C, a subset of 15 participants from the intervention group will be contacted for qualitative exit interviews.
Expected outcomes: There is limited evidence about the effects of lay navigation programs on access to PSO services among patients with lung cancer. This work addresses this knowledge gap by evaluating the feasibility, acceptability, and preliminary impact of C\&C on patients with lung cancer. The findings of the proposed work will expand the body of evidence supporting lay navigation to the lung cancer population, contributing to the evidence base for patient-centred care.
- Conditions
- Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Patient Navigation
- Being tested
- Care & Connect
- Keywords
- Lay navigation, Lung cancer, Access to care, Patient navigation, Feasibility, RCT, Pilot, Acceptability
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care & ConnectBehavioural
6-month lay navigation program. Lay navigators provide basic psychosocial and informational support and health system navigation through phone call or video conference. Sessions held with patients are variable based on patients' needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group receive Care \& Connect (C\&C), a 6-month lay navigation program, in addition to usual care. Trained lay navigators provide psychosocial and informational support and assist with health system navigation, including directing patients to appropriate resources, facilitating referrals to psychosocial services as appropriate, and connecting participants with relevant hospital and community resources. Receives: Behavioral: Care & Connect |
| Usual Care | No intervention | Participants in the control group receive usual care, including routine treatment and follow up in outpatient oncology clinics. Usual care includes distress screening (whereby patients are invited to complete the Edmonton Symptom Assessment System-Revised as part of clinic visits), with results reviewed by clinic staff and communicated to oncologists for further assessment and referral to specialized services as needed. Participants may also be referred to specialized services based on clinical judgement or patient request and have access to standard informational and educational resources available through the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessed by Recruitment Rates
≥50% recruitment rate (#patients consented/ #patients eligible and approached)
Measured: From study start date to the end of treatment at 6 months
Feasibility Assessed by Questionnaire Completion
≥80% baseline questionnaire completion rate (#patients who complete baseline questionnaire/ #patients consented)
Measured: From study start date to the end of treatment at 6 months
Feasibility Assessed by Questionnaire Completion
≥65% questionnaire completion rate at follow-up (i.e., 3- and 6-months) (#patients who complete each follow-up questionnaire/ #patients matched with a navigator or #patients who complete each follow-up questionnaire/ #patients randomized to the control group)
Measured: From study start date to the end of treatment at 6 months
Feasibility Assessed by Protocol Adherence
≥65% of patients completing at least 1 session with a lay navigator
Measured: From study start date to the end of treatment at 6 months
Acceptability
Intervention acceptability will be assessed using the Patient Satisfaction with Navigator-Interpersonal Relationship scale (PSN-I), a 9-item self-report measure of patients' satisfaction with the relationship with their navigator. Higher PSN-I scores indicate greater patient satisfaction. Acceptability is defined as ≥70% of participants scoring ≥30 on the PSN-I.
Measured: This measure will be administered at 3 months and 6 months
Secondary outcomes (7)
Referral of Care to Psychosocial Oncology Services
This outcome is operationalized as the proportion of patients and patient's number of sessions of specialized Psychosocial Oncology (PSO) services within the hospital setting during the study period. Data regarding PSO services use will be collected from participants' medical record.
Measured: From study start date to the end of treatment at 6 months
Referral of Care to Palliative Services
This outcome is operationalized as the proportion of patients and patient's number of sessions of specialized palliative care within the hospital setting during the study period. Data regarding palliative care use will be collected from participants' medical record.
Measured: From study start date to the end of treatment at 6 months
Depressive symptoms using the PHQ-9
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item measure of depression. A four-point Likert scale scores from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. Higher scores are related to higher depression severity.
Measured: This measure will be administered at baseline, 3 months and 6 months
Generalized anxiety symptoms using the GAD-7
Generalized anxiety will be assessed using the Generalized Anxiety Disorder scale (GAD-7). The GAD-7 is a 7-item self-report measure designed to screen the severity of GAD symptoms. Items are scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with a total score ranging from 0 to 21. Scores from 0-4 indicate minimal anxiety, 5-9 indicate mild anxiety, 10-14 indicate moderate anxiety, and 15-21 indicate severe anxiety.
Measured: This measure will be administered at baseline, 3 months and 6 months
Distress about death and dying symptoms using the DADDS
Distress about death and dying will be assessed using the Death and Dying Distress Scale (DADDS). The DADDS is a 15-item self-report measure assessing specific concerns of advanced cancer patients about end of life, feeling a burden to others and wasted opportunities. It is scored on a six-point Likert scale from 0 (no distress) to 5 (very much distress), with a total score ranging from 0 to 75, a greater score indicating higher death anxiety and distress.
Measured: This measure will be administered at baseline, 3 months and 6 months
Patient satisfaction with cancer care using the PSCC
Patient satisfaction with cancer care will be measured with the Patient Satisfaction with Cancer-Related Care Measure (PSCC). The PSCC is an 18-item questionnaire that addresses multiple domains, including: access/logistics, interpersonal skills of the provider, information gathering and reporting, and coordination of care. PSCC items are rated on 5-point Likert scales: "1 = Strongly Agree", "2 = Agree", "3 = Neutral", "4 = Disagree", and "5 = Strongly Disagree". A lower PSCC total score indicates higher satisfaction level. The PSCC questionnaire has a score range between a minimum of 18 (best score) and a maximum of 90 (worst score).
Measured: This measure will be administered at baseline, 3 months and 6 months
Patient satisfaction with cancer care using the CEQ-INS
Patient satisfaction with cancer care will be measured with the Clinical Evaluation Questionnaire-Information Navigation and Support (CEQ-INS). CEQ-INS is a 19-item self-reported instrument with questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Higher scores correlate with higher patient satisfaction with the information and support provided from their care team.
Measured: This measure will be administered at baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Non-Small Cell Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilla Shapiro, University Health Network, Toronto
- Investigators
- Gilla K Shapiro, PhD, Principal investigator, Princess Margaret Cancer Centre, University Health NetworkGary Rodin, MD, Principal investigator, Princess Margaret Cancer Centre, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548788
- Sponsor's protocol ID
- CAPCR#24-5089
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of the Care and Connect Program for Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT07548788
- Acronym / sponsor ID
- CAPCR#24-5089
- Conditions
- Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Patient Navigation
- Keywords
- Lay navigation, Lung cancer, Access to care, Patient navigation, Feasibility, RCT, Pilot, Acceptability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Apr 2026 (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.
Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Studies have consistently found that patients with cancer have a high number of unmet needs, including psychological, physical, and informational. Navigation programs represent a potentially promising, equitable, and cost-effective approach to address the unmet needs of patients with lung cancer, but there is limited evidence about their effectiveness in patients with lung cancer. The investigators developed and have implemented a volunteer lay navigator program, Care and Connect (C\&C), which aims to proactively reduce distress in patients, provide information and support, and increase access to treatment and supportive care resources. The proposed pilot randomized controlled trial (RCT) project plans to 1) assess the feasibility and acceptability of referral to C\&C and, 2) examine the preliminary effectiveness of C\&C.
Methods: The current study is a 2-arm, parallel group, mixed methods, pilot RCT with a 1:1 allocation ratio and 3 timepoints: baseline (T0), 3 months (T1), 6 months (T2). It is designed to test the trial feasibility and acceptability of the C\&C intervention in patients with lung cancer. In total, 50 participants will be randomized to receive the C\&C intervention or usual care only (25 per arm). At each timepoint, data will be collected on participants' access to psychosocial (PSO) services, psychological wellbeing, and satisfaction with care through participant medical record and a survey. To gain additional insights regarding the acceptability, feasibility, and impact of C\&C, a subset of 15 participants from the intervention group will be contacted for qualitative exit interviews.
Expected outcomes: There is limited evidence about the effects of lay navigation programs on access to PSO services among patients with lung cancer. This work addresses this knowledge gap by evaluating the feasibility, acceptability, and preliminary impact of C\&C on patients with lung cancer. The findings of the proposed work will expand the body of evidence supporting lay navigation to the lung cancer population, contributing to the evidence base for patient-centred care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Care & ConnectParticipants in the intervention group receive Care \& Connect (C\&C), a 6-month lay navigation program, in addition to usual care. Trained lay navigators provide psychosocial and informational support and assist with health system navigation, including directing patients to appropriate resources, facilitating referrals to psychosocial services as appropriate, and connecting participants with relevant hospital and community resources. |
| Usual Care | No intervention | –Participants in the control group receive usual care, including routine treatment and follow up in outpatient oncology clinics. Usual care includes distress screening (whereby patients are invited to complete the Edmonton Symptom Assessment System-Revised as part of clinic visits), with results reviewed by clinic staff and communicated to oncologists for further assessment and referral to specialized services as needed. Participants may also be referred to specialized services based on clinical judgement or patient request and have access to standard informational and educational resources available through the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) of any stage
- Age ≥ 18
- Have completed their first medical appointment at the Medical Oncology Lung Cancer Clinic at Princess Margaret Cancer Centre (PM), University Health Network
- Cognitive capacity to consent and complete questionnaires
Key exclusion criteria (4 listed)
- Behavioural safety alert on medical record that would make their participation in Care \& Connect inappropriate
- Enrolment in another navigation study within University Health Network
- Patients who come to PM for a clinical trial visit
- Inability to communicate and read in English
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 |
|---|---|---|
| Care & Connect6-month lay navigation program. Lay navigators provide basic psychosocial and informational support and health system navigation through phone call or video conference. Sessions held with patients are variable based on patients' needs. | Behavioural | Intervention Group |
Primary outcome
Feasibility Assessed by Recruitment Rates
Time frame: From study start date to the end of treatment at 6 months
≥50% recruitment rate (#patients consented/ #patients eligible and approached)
Feasibility Assessed by Questionnaire Completion
Time frame: From study start date to the end of treatment at 6 months
≥80% baseline questionnaire completion rate (#patients who complete baseline questionnaire/ #patients consented)
Feasibility Assessed by Questionnaire Completion
Time frame: From study start date to the end of treatment at 6 months
≥65% questionnaire completion rate at follow-up (i.e., 3- and 6-months) (#patients who complete each follow-up questionnaire/ #patients matched with a navigator or #patients who complete each follow-up questionnaire/ #patients randomized to the control group)
Feasibility Assessed by Protocol Adherence
Time frame: From study start date to the end of treatment at 6 months
≥65% of patients completing at least 1 session with a lay navigator
Acceptability
Time frame: This measure will be administered at 3 months and 6 months
Intervention acceptability will be assessed using the Patient Satisfaction with Navigator-Interpersonal Relationship scale (PSN-I), a 9-item self-report measure of patients' satisfaction with the relationship with their navigator. Higher PSN-I scores indicate greater patient satisfaction. Acceptability is defined as ≥70% of participants scoring ≥30 on the PSN-I.
7 secondary outcomes
Referral of Care to Psychosocial Oncology Services
Time frame: From study start date to the end of treatment at 6 months
Referral of Care to Palliative Services
Time frame: From study start date to the end of treatment at 6 months
Depressive symptoms using the PHQ-9
Time frame: This measure will be administered at baseline, 3 months and 6 months
Generalized anxiety symptoms using the GAD-7
Time frame: This measure will be administered at baseline, 3 months and 6 months
Distress about death and dying symptoms using the DADDS
Time frame: This measure will be administered at baseline, 3 months and 6 months
Patient satisfaction with cancer care using the PSCC
Time frame: This measure will be administered at baseline, 3 months and 6 months
Patient satisfaction with cancer care using the CEQ-INS
Time frame: This measure will be administered at baseline, 3 months and 6 months
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Research Coordinator contact
Gilla K Shapiro, PhD principal investigator
Princess Margaret Cancer Centre, University Health Network
Gary Rodin, MD principal investigator
Princess Margaret Cancer Centre, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care & Connect in people with Lung Cancer Non-Small Cell Cancer (NSCLC) and Lung Cancer Small Cell Lung Cancer (SCLC), run by University Health Network, Toronto at 1 site in Canada.
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 4 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gilla K Shapiro, PhD (416-946-4501 ext.4211, gilla.shapiro@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Assessed by Recruitment Rates (time frame: From study start date to the end of treatment at 6 months). The study lists 5 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 23 Apr 2026.