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NCT03494166 · ClinicalTrials.gov registry record · NA
Post-chemotherapy Symptom Management SMART
A NA study of Cancer, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 498
- Enrollment target
- 2
- Study locations
NCT03494166: Completed NA study of Cancer, sponsored by University of Arizona.
NCT03494166 is a NA study of Cancer that has completed, run by University of Arizona. The registered enrollment target is 498 participants, below the 3,490-participant average among 615 other Cancer trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03494166, a NA study of Cancer, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 498 participants
- Enrollment target
- 2
- Study locations
Study Summary
Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms. High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N=282) or 12-week SMSH Telephone Interpersonal Counseling (TIPC, N=93) added during weeks 1-8. After 4 weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N=30) or add TIPC (N=31).
Primary Outcome
Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated the severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index
Conditions Studied
Interventions
- BEHAVIORAL Start with SMSH+TIPC
- BEHAVIORAL Start with SMSH alone
Study Locations (2)
Arizona
- Cancer Center at St. Joseph's - Phoenix
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2022-06-03 |
| Phase | NA |
What the finished NCT03494166 record still lists
NCT03494166 is an interventional study that assigns participants to a tested intervention. The registered 498 participants enrollment target is mid-sized for trials with a published cap, below the 3,490-participant average among 615 other Cancer trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Start with SMSH+TIPC is the first listed.
NCT03494166 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03494166 about?
NCT03494166 is a clinical study titled "Post-chemotherapy Symptom Management SMART". Survivors of solid tumors (N=451) who completed curative intent chemotherapy for a solid tumor within the past 2 years were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms. High need survivors were randomized initially t...
What is the current status of trial NCT03494166?
This trial is currently completed. It is a NA study. The enrollment target is 498 participants. The study started on 2018-07-01. Estimated completion is 2022-06-03.
What conditions does trial NCT03494166 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT03494166?
The interventions under investigation include: Start with SMSH+TIPC (BEHAVIORAL), Start with SMSH alone (BEHAVIORAL).
Who is sponsoring clinical trial NCT03494166?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03494166 being conducted?
This trial has 2 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03494166's enrollment target sits among peer trials
498 133rd of 615 higher than 483 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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