Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety in Rural Older Cancer Survivors

Designing for Sustainability: Co-Designing and Testing the Efficacy of a Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety for Rural Older Cancer Survivors

This clinical trial tests how well a web based toolkit works to improve cancer related emotional distress and anxiety in rural older cancer survivors. Rural older adults with cancer-related distress are particularly vulnerable to poorer mental health and cancer-related outcomes including increased difficulties identifying symptoms of anxiety, a reduced likelihood of knowing when to access mental health services, and a higher likelihood of having poorly managed CRD, even after receiving a psychosocial referral. The web based tool kit called CONNECT addresses digital literacy and supports for cancer-related distress management through interactive activities for setting up telehealth visits, accessing educational materials about cancer-related distress, and providing individualized mental health resource recommendations. Using CONNECT may improve cancer related emotional distress and anxiety in rural older cancer survivors.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Interview; Other: Survey Administration; Other: Text Message-Based Navigation Intervention; Other: Interview; Other: Educational Intervention; Other: Educational Intervention; Other: Internet-Based Intervention; Behavioral: Patient Navigation; Behavioral: Telephone-Based Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. Co-design Objective (Aim 1): Finalize the CONNECT digital tool design through qualitative co-design evaluations with stakeholders to prepare the intervention for efficacy testing.

II. Efficacy Objective (Aim 2): Evaluate the efficacy of the CONNECT digital tool in reducing cancer-related distress among rural cancer survivors and caregivers, as measured by the validated 23-item Cancer and Treatment Distress Scale (CTXD), in a randomized controlled trial.

III. Implementation Objective (Aim 3): Assess the feasibility and potential for scale-up of the CONNECT intervention in rural communities and healthcare settings through qualitative interviews.

SECONDARY OBJECTIVES:

I. Assess self-reported healthcare resource utilization over the 12-month study period. (Aim 2, Efficacy Testing)

II. Assess self-reported shared device use for accessing health-related information and services. (Aim 2, Efficacy Testing)

III. Assess self-reported telehealth utilization, including portal use, completed visits, and visit modality. (Aim 2, Efficacy Testing)

IV. Evaluate cancer survivors' unmet needs using a validated 35-item unmet needs survey. (Aim 2, Efficacy Testing)

V. Evaluate caregiver strain using the validated 13-item Caregiver Strain Index. (Aim 2, Efficacy Testing)

OUTLINE: Advisory board members are assigned to arm I, patients and their caregivers are randomized to arm II or III.

ARM I: Co-design / Advisory Board Arm (Non-randomized) Advisory board members participate in qualitative co-design activities to refine the CONNECT digital tool prior to efficacy testing. Activities include small-group workshops, interviews, field-testing, and surveys focused on usability, content relevance, and acceptability of the platform.

ARM II: Intervention (CONNECT) Arm: Participants receive access to the CONNECT digital platform, which includes educational materials on cancer-related distress management, guidance on telehealth use, and personalized recommendations for supportive resources. They complete a guided onboarding tutorial with a Study Team Member, receive up to four structured review sessions (20 minutes each) by phone or video, and get automated text message reminders every two weeks for four months to encourage engagement.

Control Arm: Participants receive usual care plus a mailed educational brochure about managing cancer-related distress. They do not receive access to the CONNECT platform or coaching sessions.

ARM III: Patients are mailed an educational brochure about distress management on study. AIM 3: Scale-up / Implementation Assessment A subsample of participants from Arms II and III will participate in exit interviews to assess potential implementation outcomes, sustainability, and barriers/facilitators for scaling CONNECT in rural communities and healthcare settings.

• Study Type: Interventional
• Enrollment (Estimated): 578
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 312-503-1986; Email: circle.ruralhealth@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Marquita W. Lewis; Phone Number: 312-503-1986; Email: marquita.lewis-thames@northwestern.edu
      • Principal Investigator: Marquita W. Lewis, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• AIM 1: Invited by a member of the study team

• AIM 1: In the following or related field:

  • Healthcare professionals (physicians, nurses, pharmacists, etc.)
  • Patient advocates and representatives
  • Researchers in healthcare or technology fields
  • Healthcare administrators and managers
• AIM 1: Must be over 18 years old
• AIM 1: English-speaking
• AIM 1: Willing and able to provide informed consent
• AIM 2 (RURAL OLDER CANCER SURVIVORS): A rural resident based on the Health Resources & Services Administration (HRSA) rural analyzer
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Self-report of diagnosis with any cancer
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Self-report posttreatment (i.e., completion of curative intent therapy including surgery, chemotherapy, molecularly targeted, and endocrine therapy)
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Have access to a computer, a smartphone, or a tablet computer
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Aged > 65 years old
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Assessed as having Cancer and Treatment Distress scale (CTXD) scores > 0.85 at screening
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Have a caregiver willing to participate
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Non-institutionalized
• AIM 2 (RURAL OLDER CANCER SURVIVORS): English proficient
• AIM 2 (RURAL OLDER CANCER SURVIVORS): Willing and able to provide informed consent
• AIM 2 (CAREGIVER): An identified informal caregiver of an eligible ROCS (caregivers include, but are not limited to, a child, partner, or friend; caregivers can reside in a rural or urban area and may or may not live with the ROCS
• AIM 2 (CAREGIVER): Have internet access
• AIM 2 (CAREGIVER): ≥ 18 years old
• AIM 2 (CAREGIVER): Non-institutionalized
• AIM 2 (CAREGIVER): English proficient
• AIM 2 (CAREGIVER): Willing and able to provide informed consent
• AIM 3 (FINAL WORKSHOP): Includes providers, medical and practice managers, patient care coordinators, and medical health technologists

Exclusion Criteria:

• 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
• AIM 2 (RURAL OLDER CANCER SURVIVORS AND CAREGIVER): Are inpatients
• AIM 2 (RURAL OLDER CANCER SURVIVORS AND CAREGIVER): Cognitive impairment precludes the ability to provide written consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Advisory board); Advisory board members complete small group workshops, interviews and surveys on study.	Other: Interview; Complete interview; Other: Survey Administration; Ancillary study; Other: Interview; Complete small group workshop
Experimental: Arm II (CONNECT platform); Patients and their caregivers receive access to the CONNECT platform, which includes educational materials on distress management, guides to telehealth and personalized recommendations for resources. Patients and their caregivers complete a guided tutorial of the platform with a research assistant at the start of the intervention period, receive biweekly phone calls with the research assistant, for 20 minutes starting on 14 days to 2 months to review the four cancer-related management functions and receive a text message reminders to encourage use, every 2 weeks for 4 months.	Other: Interview; Complete interview; Other: Survey Administration; Ancillary study; Other: Text Message-Based Navigation Intervention; Receive text message reminders; Other Names: Automated Text Message-Based Navigation; Text Message-Based Navigation; Other: Interview; Complete small group workshop; Other: Educational Intervention; Receive educational materials on distress management and guides to telehealth; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Receive written educational brochure about distress management; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Internet-Based Intervention; Receive access to CONNECT platform; Behavioral: Patient Navigation; Receive personalized recommendations for resources; Other Names: Patient Navigator Program; Behavioral: Telephone-Based Intervention; Complete calls with research assistant
Active Comparator: Arm III (Educational brochure); Patients are mailed an educational brochure about distress management on study.	Other: Interview; Complete interview; Other: Survey Administration; Ancillary study; Other: Interview; Complete small group workshop; Other: Educational Intervention; Receive educational materials on distress management and guides to telehealth; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; Receive written educational brochure about distress management; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Related Distress (validated 23-item scale)	Cancer-related distress will be measured using the Cancer and Treatment Distress Scale (23 items; item scores 0-3; higher scores indicate greater distress). The CTXD assesses distress over the past week and includes six subscales: (1) uncertainty, (2) family strain, (3) health burden, (4) finances, (5) identity/appearance, and (6) medical demands. The primary outcome is the mean cumulative score across all items and subscales. A mean score above 0.85 indicates elevated distress in long-term survivors. The CTXD has demonstrated high validity and reliability across time, from pre-treatment to 18 years post-treatment, with Cronbach's alphas ranging from 0.77 to 0.90. The subscales align with the psychosocial domain identified in the NCCN Guidelines for Distress Management.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Healthcare Resource Usage	Self-reported healthcare service usage will be measured as a count outcome at 4, 8, and 12 months post-randomization. At each follow-up, participants will report the number of times they accessed healthcare services, including primary care, oncology consultations, mental health counseling, urgent care, and survivorship care visits, since their last assessment. Data will be collected using a structured checklist within the participant survey. Evaluable participants are those who complete the survey. Both service-specific and total counts will be summarized, and a cumulative total across all intervals (0-12 months) will serve as the overall indicator of healthcare resource utilization.	Up to 12 months
Self-reported Shared Device Use	Assessed as a binary outcome at each follow-up time point (4, 8, and 12 months post-randomization). Participants will report whether they shared a digital device (e.g., smartphone, tablet, or computer) with a caregiver, family member, or friend to access health-related information or services since their last assessment. The structured survey item captures both access and behavioral engagement with health technologies through shared devices.	Up to 12 months
Telehealth Utilization (self-reported use of portal, completed visits, and visit modality)	Telehealth utilization will be self-reported by rural cancer survivors (ROCS) and caregivers at baseline and follow-up assessments at 4, 8, and 12 months post-randomization. Participants will indicate whether they have used any telehealth services in the last 4 months, and if so, specify the type (e.g., oncology follow-up, primary care, mental health), frequency, and modality (e.g., video, phone). Utilization will be operationalized as a binary indicator at each time point (1 = used, 0 = did not use, NA = missing). We will also summarize cumulative utilization across all time points to derive an overall indicator of self-reported telehealth utilization during the 12-month study period.	Up to 12 months
Cancer Survivors' Unmet Needs (validated 35-item scale)	Cancer Survivors' Unmet Needs will be assessed using a validated 35-item questionnaire evaluating emotional, informational, physical, and practical support needs. A total unmet needs score and domain-specific scores will be calculated per the scoring manual, with higher scores indicating greater levels of unmet need. The outcome will be analyzed as a continuous variable at 4, 8, and 12 months post-randomization. Primary analyses will compare total unmet needs between the CONNECT and control groups at 12 months, with longitudinal models assessing changes across all time points.	Up to 12 months
Caregiver Strain Index (validated 13-item scale)	Caregiver strain will be measured using the Caregiver Strain Index (CSI), a validated 13-item scale assessing the level of strain experienced by caregivers after hospital discharge of an elderly family member. Each item is scored as 0 (no) or 1 (yes), with total scores ranging from 0 to 13, where higher scores indicate greater caregiver strain. The CSI will be administered at baseline and follow-up assessments (4, 8, and 12 months post-randomization). The outcome will be analyzed as a continuous variable, with the primary comparison of mean CSI scores between the CONNECT and control arms at 12 months to evaluate the cumulative effect of the intervention.	Up to 12 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI); National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Marquita W Lewis, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2025
• Primary Completion (Estimated): August 26, 2031
• Study Completion (Estimated): August 26, 2032

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Methods; Interviews as Topic; Early Intervention, Educational; Educational Status; Patient Navigation
• Other Study ID Numbers: NU 24CC20 (Other Identifier: Northwestern University); P30CA060553 (U.S. NIH Grant/Contract); NCI-2024-09384 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STU00222660; R01NR021666 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No