MedTrace Logo

Post-chemotherapy Symptom Management SMART

NCT03494166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2023-10-19

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

BEHAVIORAL

Start with SMSH+TIPC

See arm/group descriptions

BEHAVIORAL

Start with SMSH alone

See arm/group descriptions

Sponsors & Collaborators

  • Michigan State University

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Arizona

    lead OTHER

Principal Investigators

  • Terry Badger, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2022-06-03
Completion
2022-06-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494166 on ClinicalTrials.gov