Online Program for Depression in Cancer Patients

(iPath Pilot Trial)

Overseen By Paul Barr, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Suicidal ideation, Bipolar, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and usability of an online program called iPath\*D for cancer patients with symptoms of depression. The program connects patients to various treatments both online and in-person. It targets new cancer patients beginning treatment at Dartmouth Cancer Center who experience moderate to severe depression. Participants must communicate in English and have not recently received treatment for a mental health condition. As an unphased trial, this study provides patients the opportunity to explore innovative support options for managing depression alongside cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently receiving treatment for a mental health condition, you may not be eligible to participate.

What prior data suggests that this online program is safe for cancer patients with depression?

Research has shown that the iPath*D program is being tested for its effectiveness in assisting cancer patients who also experience depression. Although specific safety information for iPath*D is not available, it is an online tool, suggesting it is likely safe as it does not involve medication or physical treatments.

The purpose of iPath*D is to connect patients with proven treatments for depression. These treatments have been tested and shown to be effective. One common treatment is psychotherapy, a type of talk therapy that patients usually receive well.

While detailed safety data is not available, the online nature of iPath*D suggests it should be safe for users. It is designed to help patients find treatments rather than serve as a treatment itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about iPath*D because it offers a unique approach to addressing depression in cancer patients. Unlike traditional treatments that often rely on medication or in-person therapy sessions, iPath*D is an online platform that provides a blend of evidence-based treatments both online and in-person, making mental health care more accessible and flexible for patients dealing with cancer. Additionally, iPath*D is facilitated by an interactive decision aid, which helps tailor the treatment to the individual needs of patients, potentially leading to more personalized and effective outcomes. This innovative method not only broadens access to care but also empowers patients to engage actively in their treatment journey.

What evidence suggests that the iPath*D program is effective for depression in cancer patients?

Research has shown that online programs can greatly assist cancer patients dealing with depression. The COPE-D program, a similar initiative, improved depression and quality of life for 65% of its users. These programs often incorporate Cognitive Behavioral Therapy (CBT), which effectively reduces negative feelings in cancer patients. In this trial, the iPath*D platform connects patients with depression to various treatments and is designed for ease of use and positive reception. Early evidence suggests that iPath*D could positively impact the mental health of cancer patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Paul Barr, Ph.D.

Principal Investigator

Dartmouth College

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are starting treatment at NCCC North and returning for chemo teach or radiation simulation. They must be able to communicate in English and have mild to moderately severe depression, as indicated by a score of 10-27 on the PHQ-9 depression scale.

Inclusion Criteria

PHQ-9 score between ≥10 and ≤27

Can communicate in English

I am a new patient at Dartmouth Cancer Center North, here for my chemo teach or radiation simulation.

Exclusion Criteria

Mild Depression (PHQ-9 score ≥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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Online screening

Treatment

Participants use the iPath*D online platform to access depression treatment options

6 weeks

Online access to treatment options

Follow-up

Participants are monitored for changes in mental health literacy, quality of life, and treatment adherence

6 weeks

Online follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• iPath*D

Trial Overview The study is testing iPath*D, an online pathway designed to help cancer patients with symptoms of depression access treatment. The goal is to see if this digital tool is both acceptable and user-friendly for those undergoing cancer therapy.

How Is the Trial Designed?

Group I: iPath*D Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 27 participants with advanced cancer showed that a six-lesson internet-delivered cognitive behavioral therapy (iCBT) was feasible and acceptable, with high treatment satisfaction reported by most participants.

Participants who completed the iCBT experienced significant reductions in anxiety and depression symptoms, suggesting that this online therapy could be an effective support for individuals facing mental health challenges due to advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed methods pilot and feasibility open trial of internet-delivered cognitive behaviour therapy (iCanADAPT Advanced) for people with advanced cancer with depression and/or anxiety. Murphy, MJ., Newby, JM., Butow, P., et al.[2023]

The study will evaluate the effectiveness of the online self-help program epos in reducing anxiety and depression symptoms among 325 German-speaking cancer patients transitioning from inpatient to outpatient care.

If successful, epos could provide a valuable, accessible adjunct to traditional face-to-face psycho-oncological support, particularly for patients facing barriers to in-person interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial. Tsiouris, A., Mayer, A., Nölke, C., et al.[2022]

The COPE-D intervention significantly improved depression and quality of life for underserved cancer patients, with 65% of participants showing treatment improvement and 56% achieving a significant treatment response.

Outcomes such as suicidal ideation, anxiety, sleep disturbance, and social isolation also improved, indicating the intervention's broad effectiveness across various mental health aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative depression care sensitive to the needs of underserved patients with cancer: Feasibility, acceptability and outcomes. Price, S., Hamann, HA., Halaby, L., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-depressive-disorder-2023-a00cd

Online Program for Depression in Cancer Patients The COPE-D intervention significantly improved depression and quality of life for underserved cancer patients, with 65% of participants showing treatment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04973930

Study Details | NCT04973930 | Feasibility Trial of Tele-IPT ... We will randomly assign 20 patients with both non-metastatic breast cancer and major depression to 12 weeks of tele-therapy (by Zoom) with either interpersonal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11124676/

A systematic review and network meta-analysis - PMC This study also suggested that CBT had a significant effect in alleviating negative emotions in patients with cancer.

4. nature.com nature.com/articles/s44184-025-00119-9

Prediction of individual patient outcomes to psychotherapy ... The variables predicted a meaningful proportion of variance in end-of-treatment depression severity for cognitive behavioral therapy (39.7%), ...

5. c4tbh.org c4tbh.org/research-study/digital-mental-health-to-improve-breast-cancer-outcomes/

Digital Mental Health to Improve Breast Cancer Outcomes We hypothesize that iPath will be acceptable, highly usable, and demonstrate preliminary impact on mental health literacy among patients with breast cancer.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/338158

iPath*D (Aim 2) The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath\*D) is acceptable and usable ...

7. reporter.nih.gov reporter.nih.gov/project-details/8099433

Project Details - NIH RePORTER Mental health and psychosocial factors associated with cancer are poorly recognized and under-treated. The Mental Health Assessment and Dynamic Referral for ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05302375/developing-and-testing-an-online-pathway-from-screening-to-treatment-for-depression-in-oncology-ipathd-aim-2

iPath*D (Aim 2) | Clinical Research Trial Listing The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable ...