CanceriPath PilotNCT05302375
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
A study testing iPath*D in people with Cancer and Depression, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Depression
- What is being tested?
- iPath*D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Nov 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)
- New patients who are beginning treatment at Dartmouth Cancer Center North and returning for their chemo teach or radiation simulation visit
- Can communicate in English
- PHQ-9 ≥10 and ≤27
Who cannot join
- Mild Depression (PHQ-9 ≥10)
- Individuals who screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6 on the Columbia-Suicide Severity Rating Scale (C-SSR).
- Individuals with bipolar disorder or psychosis (documented in the EMR)
- Individuals currently receiving treatment for a mental health condition (documented in the EMR or self-reported during eligibility screening)
- Significant cognitive impairment (Callahan's Six Item Screener of cognitive function ≤ 4; Self-reported during eligibility screening)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Cancer Center St. Johnsbury
Saint Johnsbury, Vermont, 05819
About this study
The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.
Read the detailed description
The investigators will determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. iPath*D will be designed to increase screening, mental health literacy, and treatment access. Patients will access their iPath*D account online to review their PHQ-9 score and its interpretation, followed by an interactive depression decision aid comparing information on a range of online and in-person treatment options. Upon review of the decision aid, participants will be able to directly connect to a treatment path via embedded hyperlinks in the decision aid.
The investigators will determine the usability, acceptability, and feasibility of iPath*D. The investigators will explore the hypothesis that iPath*D will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access. The tool for the study was developed during a preliminary portion (Aim 1) of the project, under D-H IRB number STUDY02001240 .
This approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, St Johnsbury, VT (Dartmouth Cancer Center North) (n=30) with moderate-severe depression, Aim 2 of the project.
- Conditions
- Cancer, Depression
- Being tested
- iPath*D
- Keywords
- shared decision making, decision aid, depression
- Medical subject headings
- Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPath*DOther
Online pathway from screening to treatment for depression in cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| iPath*D | Experimental | An online platform that connects patients screening positive for clinically significant depression in cancer settings to a range of online and inperson evidence-based treatments, facilitated by an interactive DA. Receives: Other: iPath*D |
What is being measured
The primary outcome is the main question the study is designed to answer.
System usability
System Usability Scale (10 items; mean ≥68/100),
Measured: 2 weeks
Acceptability of intervention
Acceptability of Intervention Measure (4 items), mean ≥4/5
Measured: 2 weeks
Feasibility of intervention
Feasibility of Intervention Measure (4 items), mean ≥4/5
Measured: 2 weeks
Change in number of patients selecting a treatment path to access
Click on link to access online treatment service | indicate in self-report survey accessing local resources
Measured: 2 weeks, 4 weeks, 6 weeks
Change in Mental Health Literacy (MHL)
A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding \& beliefs. Higher scores indicate higher MHL.
Measured: Baseline, 2 weeks
Secondary outcomes (6)
Change in PHQ-9 completion (exploratory outcome)
Number of patients who complete Patient Health Questionnaire (PHQ-9), a validated nine item depression scale. A score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in treatment initiation (exploratory outcome)
Proportion of patients who self-report treatment initiation e.g., fill antidepressant prescription, visited with psychiatrist for talk therapy, began a cCBT program, or other service
Measured: 2 weeks, 4 weeks, 6 weeks
Change in treatment adherence (exploratory outcome)
Proportion of patients who self-report continued adherence to treatment e.g., antidepressant refill (yes/no), number of talk therapy sessions completed, or Computerised Cognitive Behavioural Therapy (cCBT) modules completed
Measured: 2 weeks, 4 weeks, 6 weeks
Decisional regret (exploratory outcome)
The Decisional Regret Scale assesses satisfaction with a healthcare decision (5-items, scores range from 0-100, with higher scores indicating high regret)
Measured: 6 weeks
Change in PHQ-9 score (exploratory outcome)
Response; 5-point reduction in baseline PHQ-9 score. Remission; PHQ-9 score of <5 points
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in quality of life (exploratory outcome)
Functional Assessment of Cancer Therapy-General (FACT-G) scale (27-items, scores range from 0-108 with higher scores indicating higher quality of life)
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jul 2024
- Primary completion31 Jul 2026
- Study completion30 Nov 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Paul J. Barr, Trustees of Dartmouth College
- Investigators
- Paul Barr, Ph.D., Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302375
- Sponsor's protocol ID
- STUDY02002016
- Other IDs
- R21CA249767
- Acronym
- iPath Pilot
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of this study, the investigators plan to make available, upon request, a public use file of all participant-level study data. Investigators will use appropriate de-identification and security measures. Plain-language descriptions of data sharing plans will be included in informed consents. Dartmouth College will retain ownership and all rights to all intellectual property and will provide public access to data. Appropriate documentation will also be provided regarding information about the methodology and procedures used to collect the data, details about codes and definitions of variables.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
- ClinicalTrials.gov ID
- NCT05302375
- Acronym / sponsor ID
- iPath Pilot / STUDY02002016
- Conditions
- Cancer, Depression
- Keywords
- shared decision making, decision aid, depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Mar 2022 (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.
The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.
Detailed description
The investigators will determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. iPath*D will be designed to increase screening, mental health literacy, and treatment access. Patients will access their iPath*D account online to review their PHQ-9 score and its interpretation, followed by an interactive depression decision aid comparing information on a range of online and in-person treatment options. Upon review of the decision aid, participants will be able to directly connect to a treatment path via embedded hyperlinks in the decision aid.
The investigators will determine the usability, acceptability, and feasibility of iPath*D. The investigators will explore the hypothesis that iPath*D will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access. The tool for the study was developed during a preliminary portion (Aim 1) of the project, under D-H IRB number STUDY02001240 .
This approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, St Johnsbury, VT (Dartmouth Cancer Center North) (n=30) with moderate-severe depression, Aim 2 of the project.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iPath*D | Experimental | Other: iPath*DAn online platform that connects patients screening positive for clinically significant depression in cancer settings to a range of online and inperson evidence-based treatments, facilitated by an interactive DA. |
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)
- New patients who are beginning treatment at Dartmouth Cancer Center North and returning for their chemo teach or radiation simulation visit
- Can communicate in English
- PHQ-9 ≥10 and ≤27
Key exclusion criteria (5 listed)
- Mild Depression (PHQ-9 ≥10)
- Individuals who screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6 on the Columbia-Suicide Severity Rating Scale (C-SSR).
- Individuals with bipolar disorder or psychosis (documented in the EMR)
- Individuals currently receiving treatment for a mental health condition (documented in the EMR or self-reported during eligibility screening)
- Significant cognitive impairment (Callahan's Six Item Screener of cognitive function ≤ 4; Self-reported during eligibility screening)
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 |
|---|---|---|
| iPath*DOnline pathway from screening to treatment for depression in cancer patients. | Other | iPath*D |
Primary outcome
System usability
Time frame: 2 weeks
System Usability Scale (10 items; mean ≥68/100),
Acceptability of intervention
Time frame: 2 weeks
Acceptability of Intervention Measure (4 items), mean ≥4/5
Feasibility of intervention
Time frame: 2 weeks
Feasibility of Intervention Measure (4 items), mean ≥4/5
Change in number of patients selecting a treatment path to access
Time frame: 2 weeks, 4 weeks, 6 weeks
Click on link to access online treatment service | indicate in self-report survey accessing local resources
Change in Mental Health Literacy (MHL)
Time frame: Baseline, 2 weeks
A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding \& beliefs. Higher scores indicate higher MHL.
6 secondary outcomes
Change in PHQ-9 completion (exploratory outcome)
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in treatment initiation (exploratory outcome)
Time frame: 2 weeks, 4 weeks, 6 weeks
Change in treatment adherence (exploratory outcome)
Time frame: 2 weeks, 4 weeks, 6 weeks
Decisional regret (exploratory outcome)
Time frame: 6 weeks
Change in PHQ-9 score (exploratory outcome)
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in quality of life (exploratory outcome)
Time frame: Baseline, 6 weeks
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. At the conclusion of this study, the investigators plan to make available, upon request, a public use file of all participant-level study data. Investigators will use appropriate de-identification and security measures. Plain-language descriptions of data sharing plans will be included in informed consents. Dartmouth College will retain ownership and all rights to all intellectual property and will provide public access to data. Appropriate documentation will also be provided regarding information about the methodology and procedures used to collect the data, details about codes and definitions of variables.
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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. This study is not recruiting at the moment.
Paul Barr, Ph.D. principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPath*D in people with Cancer and Depression, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System usability (time frame: 2 weeks). 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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.