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NCT03743415 · ClinicalTrials.gov registry record · NA
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management
A NA study, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 908
- Enrollment target
NCT03743415 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 908 participants.
The verdict
NCT03743415, a NA study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 908 participants
- Enrollment target
Study Summary
Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Design: The investigators selected the SMART design for this study over alternative designs (e.g.,implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. SMART designs, although newer, show promise in developing the sequences of evidence-based interventions for more efficient and individualized patient- and caregiver-centered care. The investigators will use findings from this study to create an algorithm for clinically meaningful decision making about symptom management for survivors and their caregivers to be tested in future implementation/dissemination studies. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.
Interventions
- BEHAVIORAL Handbook
- BEHAVIORAL TIP-C plus Handbook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 908 participants |
| Start Date | 2019-01-16 |
| Est. Completion | 2022-05-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03743415
The ClinicalTrials.gov registry entry for NCT03743415 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 908 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Handbook is the first listed.
NCT03743415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03743415 about?
NCT03743415 is a clinical study titled "Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management". Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Design: The investigators selected the SMART design for this study over alternative desi...
What is the current status of trial NCT03743415?
This trial is currently completed. It is a NA study. The enrollment target is 908 participants. The study started on 2019-01-16. Estimated completion is 2022-05-27.
What interventions are being tested in trial NCT03743415?
The interventions under investigation include: Handbook (BEHAVIORAL), TIP-C plus Handbook (BEHAVIORAL).
Who is sponsoring clinical trial NCT03743415?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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