N/A
Completed N=446
Post-chemotherapy Symptom Management SMART
Cancer
Source: ClinicalTrials.gov NCT03494166 ↗
Enrolled (actual)
446
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Symptom Severity Index- Comparison of Two Groups Created by First Randomization — 24.53; 25.86 score on a scale — p=.31
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Severity Index- Comparison of Two Groups Created by First Randomization |
24.53; 25.86 | .31 |
| PRIMARY Symptom Severity Index- Comparison of Two Groups Created by Second Randomization |
35.94; 38.11 | .52 |
| SECONDARY Depressive Symptoms- Comparison of Two Groups Created by First Randomization. |
11.89; 12.30 | .71 |
| SECONDARY Depressive Symptoms - Comparison of Two Groups Created by Second Randomization |
16.05; 16.81 | .79 |
Eligibility Criteria
Inclusion Criteria
- Survivors must have a new diagnosis or localized recurrence of solid tumor cancer
- Be finishing curative intent adjuvant chemotherapy or chemoradiation, and do not have any subsequent cancer treatments planned, except for radiation therapy, hormonal therapy or trastuzumab for breast cancer.
- 18 years of age or older
- Have access to a telephone
- Understand English or Spanish
- Are not currently receiving counseling and/or psychotherapy
Exclusion Criteria
- Diagnosis of a psychotic disorder in medical record verified by the recruiter
- Nursing home resident
- Bedridden
- Currently receiving counseling and/or psychotherapy.
Data sourced from ClinicalTrials.gov (NCT03494166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.