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क्लिनिकल ट्रायल NCT07290543 के लिए रक्तजनक और लसीका प्रणाली का नवोप्लाज्म, घातक ठोस नवोप्लाज्म वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety in Rural Older Cancer Survivors 578 टेलीहेल्थ

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07290543 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो रक्तजनक और लसीका प्रणाली का नवोप्लाज्म, घातक ठोस नवोप्लाज्म से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 26 अगस्त 2025 को हुई थी, और इसमें कुल 578 प्रतिभागियों के नामांकन की योजना है। नॉर्थवेस्टर्न विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 26 अगस्त 2032 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 18 दिसंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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 ...और दिखाएँ
विस्तृत विवरण
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 Trea...

और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
रक्तजनक और लसीका प्रणाली का नवोप्लाज्मघातक ठोस नवोप्लाज्म
अन्य अध्ययन आईडी
NCT नंबर
NCT07290543
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-08-26
अंतिम अद्यतन प्रकाशित
2025-12-18
अध्ययन की समाप्ति तिथि (अनुमानित)
2032-08-26
नामांकन (अनुमानित)
578
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्राथमिक उद्देश्य
सहायक देखभाल
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
अनुक्रमिक
अंधकरण
एकल अंध
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकArm I (Advisory board)
Advisory board members complete small group workshops, interviews and surveys on study.
साक्षात्कार
Complete interview
साक्षात्कार
Complete small group workshop
सर्वेक्षण प्रशासन
Ancillary study
प्रयोगात्मकArm 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 startin...और दिखाएँ
शैक्षिक हस्तक्षेप
Receive educational materials on distress management and guides to telehealth
इंटरनेट-आधारित हस्तक्षेप
Receive access to CONNECT platform
साक्षात्कार
Complete interview
रोगी नेविगेशन
Receive personalized recommendations for resources
सर्वेक्षण प्रशासन
Ancillary study
टेलीफोन आधारित हस्तक्षेप
Complete calls with research assistant
पाठ संदेश-आधारित नेविगेशन हस्तक्षेप
Receive text message reminders
सक्रिय तुलना समूहArm III (Educational brochure)
Patients are mailed an educational brochure about distress management on study.
शैक्षिक हस्तक्षेप
Receive written educational brochure about distress management
साक्षात्कार
Complete interview
सर्वेक्षण प्रशासन
Ancillary study
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ

  • 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

  • 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
Northwestern University logoनॉर्थवेस्टर्न विश्वविद्यालय
अध्ययन केंद्रीय संपर्क
संपर्क: Study Coordinator, 312-503-1986, [email protected]
1 1 देशों में अध्ययन स्थान

Illinois

Northwestern University, Chicago, Illinois, 60611, United States
Marquita W. Lewis, संपर्क, 312-503-1986, [email protected]
Marquita W. Lewis, PhD, मुख्य अन्वेषक
भर्ती जारी