578 Participants Needed

Web-Based Toolkit for Cancer

SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a web-based toolkit can reduce emotional distress and anxiety in rural older adults who have survived cancer. The toolkit, called CONNECT, offers resources such as telehealth guides and educational materials to help manage these feelings. Participants either use the CONNECT platform, engage in advisory board activities, or receive educational brochures. It suits rural cancer survivors post-treatment who have internet access and a caregiver willing to participate. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for rural cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on using a web-based toolkit to manage emotional distress, so it's unlikely that medication changes are required.

What prior data suggests that this web-based toolkit is safe for improving cancer-related emotional distress and anxiety?

Research shows that online programs, like the CONNECT toolkit, are generally safe and easy to use. Studies have found that similar online programs can effectively reduce anxiety and depression without causing major side effects. For instance, one study found that these programs helped reduce pain, lessen fatigue, and improve mood in patients without any serious negative effects. Another study showed that an online stress management tool was effective for cancer patients, with no safety issues reported.

These tools focus on teaching skills and offering support, which usually don't involve physical risks. While technical issues or frustration with digital platforms might occur, these do not harm health. Overall, online mental health tools are considered safe for managing cancer-related stress.12345

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Toolkit (CONNECT) because it offers a fresh approach to helping cancer patients manage distress through education and personalized support. Unlike traditional methods that might rely solely on printed materials or in-person consultations, CONNECT provides an interactive online platform accessible from home. This platform offers educational resources, telehealth guides, and personalized recommendations, all supported by regular check-ins from research assistants. These features aim to empower patients and caregivers with convenient, continuous support, potentially enhancing their ability to handle cancer-related challenges more effectively than current options.

What evidence suggests that the CONNECT platform is effective for managing cancer-related distress and anxiety?

Research shows that online tools like CONNECT, which participants in this trial may receive, can help reduce stress and anxiety in cancer patients. These tools often include activities and educational materials that assist patients in managing their symptoms. Studies have found that patients using similar online platforms reported feeling less anxious and depressed. CONNECT also improves digital skills, making it easier for patients to access mental health resources. By using this toolkit, older cancer survivors in rural areas might find it easier to set up online doctor visits and receive personalized mental health support. Early evidence suggests that this kind of assistance could lead to better mental health for those dealing with cancer-related stress.678910

Who Is on the Research Team?

MW

Marquita W Lewis, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for rural older adults who have survived cancer and are experiencing emotional distress and anxiety related to their condition. They should be able to use the internet and willing to engage with a web-based toolkit designed to help manage these issues.

Inclusion Criteria

For AIM 2 (RURAL OLDER CANCER SURVIVORS): A rural resident based on the Health Resources & Services Administration (HRSA) rural analyzer
For AIM 2 (RURAL OLDER CANCER SURVIVORS): Have access to a computer, a smartphone, or a tablet computer
I am over 65 years old.
See 19 more

Exclusion Criteria

For AIM 2 (RURAL OLDER CANCER SURVIVORS): Experience a cancer recurrence or a new cancer diagnosis during their participation in the trial because of the body of literature that reports increased distress associated with cancer recurrence
For AIM 2 (RURAL OLDER CANCER SURVIVORS AND CAREGIVER): Are inpatients
I can give written consent despite any cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Co-design

Advisory board members participate in qualitative co-design activities to refine the CONNECT digital tool

4-8 weeks
Multiple workshops and interviews

Intervention

Participants receive access to the CONNECT digital platform and complete a guided onboarding tutorial with structured review sessions

4 months
Biweekly phone or video calls

Follow-up

Participants are monitored for self-reported healthcare resource usage, shared device use, telehealth utilization, unmet needs, and caregiver strain

12 months
Follow-up assessments at 4, 8, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Web-Based Toolkit (CONNECT)

Trial Overview

The trial is testing CONNECT, a web-based toolkit aimed at improving mental health in older cancer survivors living in rural areas. It includes interactive activities for telehealth, educational materials on managing distress, and personalized mental health resources.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (CONNECT platform)Experimental Treatment7 Interventions
Group II: Arm I (Advisory board)Experimental Treatment2 Interventions
Group III: Arm III (Educational brochure)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Citations

Web-Based Toolkit to Improve Cancer-Related Emotional ...

This clinical trial tests how well a web based toolkit works to improve cancer related emotional distress and anxiety in rural older cancer ...

Designing for sustainability

CONNECT addresses digital literacy and supports for cancer-related distress management through interactive activities for setting up telehealth visits, ...

Web-Based Toolkit to Improve Cancer-Related Emotional ...

This clinical trial tests how well a web based toolkit works to improve cancer related emotional distress and anxiety in rural older cancer ...

Web-based educational tools and decision aids for patients ...

To provide an overview of existing interactive web-based educational tools and decision aids for patients with advanced cancer and to evaluate their development ...

Web-Based Cancer Symptom Self-Management System

Outcomes and Assessments. The primary effectiveness outcomes were PROMIS measures for anxiety, depression, fatigue, pain interference, and ...

Web-Based Toolkit to Improve Cancer-Related Emotional ...

This clinical trial tests how well a web based toolkit works to improve cancer related emotional distress and anxiety in rural older cancer ...

Web-Based Cancer Symptom Self-Management System

Can a web-based enhanced care (EC) self-management program improve patient-reported outcomes (PROs) and reduce health care resource use ...

Effects of Remote Web-Based Interventions on the ...

The remote web-based interventions were effective in reducing the intensity of physiological pain, relieving fatigue, improving depression and anxiety,

Web-Based Stress Management for Newly Diagnosed ...

In a randomized controlled trial, patients with cancer who had started first-line treatment within the previous 12 weeks were randomly assigned ...

Distress Management

guided Web-based CBT intervention for reducing cancer-distress: a randomised controlled trial. Support Care Cancer 2016;24:1043-1051.