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Hematopoietic and Lymphatic System NeoplasmNCT07290543

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

A study testing Educational Intervention, Internet-Based Intervention and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Educational Intervention, Internet-Based Intervention and Interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
578 participants
Where
1 siteUnited States
Study dates
26 Aug 2025to 26 Aug 2032
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

312-503-1986

circle.ruralhealth@northwestern.edu

United States1 site, 1 recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Marquita W. Lewis, 312-503-1986, marquita.lewis-thames@northwestern.edu

    Marquita W. Lewis, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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)

  1. 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.

Being tested
Educational Intervention, Internet-Based Intervention, Interview, Patient Navigation, Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive educational materials on distress management and guides to telehealth

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive written educational brochure about distress management

  • Internet-Based InterventionOther

    Receive access to CONNECT platform

  • InterviewOther

    Complete interview

  • InterviewOther

    Complete small group workshop

  • Patient NavigationBehavioural

    Also called Patient Navigator Program

    Receive personalized recommendations for resources

  • Survey AdministrationOther

    Ancillary study

  • Telephone-Based InterventionBehavioural

    Complete calls with research assistant

  • Text Message-Based Navigation InterventionOther

    Also called Automated Text Message-Based Navigation, Text Message-Based Navigation

    Receive text message reminders

Study groups in NCT07290543
Study groupRoleWhat they receive
Arm I (Advisory board)ExperimentalAdvisory board members complete small group workshops, interviews and surveys on study.
Receives: Other: Interview; Other: Survey Administration
Arm II (CONNECT platform)ExperimentalPatients 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.
Receives: Other: Educational Intervention; Other: Internet-Based Intervention; Other: Interview; Behavioral: Patient Navigation; Other: Survey Administration; Behavioral: Telephone-Based Intervention; Other: Text Message-Based Navigation Intervention
Arm III (Educational brochure)Active comparatorPatients are mailed an educational brochure about distress management on study.
Receives: Other: Educational Intervention; Other: Interview; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 1 year

Secondary outcomes (5)

  1. 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.

    Measured: Up to 12 months

  2. 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.

    Measured: Up to 12 months

  3. 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.

    Measured: Up to 12 months

  4. 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.

    Measured: Up to 12 months

  5. 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start26 Aug 2025
  3. Primary completion26 Aug 2031 (estimated)
  4. Study completion26 Aug 2032 (estimated)

Resources

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
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
578 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07290543
Sponsor's protocol ID
NU 24CC20
Other IDs
NCI-2024-09384, STU00222660, NU 24CC20, P30CA060553, R01NR021666
Status last verified
Dec 2025
First submitted
24 Sep 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational Intervention, Internet-Based Intervention and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Northwestern University 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 26 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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?

Contact Study Coordinator (312-503-1986, circle.ruralhealth@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer Related Distress (validated 23-item scale) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07290543.

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 18 Dec 2025.

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