Clinical Trials Logo
NCT number NCT03494166
Study type Interventional
Source University of Arizona
Contact Paul Sandoval
Phone 520-626-6000
Email sponsor@email.arizona.edu
Status Not yet recruiting
Phase N/A
Start date July 1, 2018
Completion date March 1, 2022

Clinical Trial Summary

Sample: The sample will be 344 ethnically diverse (at least 30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression and co-morbid illnesses.

Design: The SMART design incorporates two interventions with proven efficacy and addresses heterogeneity of survivors' responses by following the clinical logic of starting with one intervention, assessing its success, and continuing it when effective. High need survivors will be initially randomized to receive 1) weekly symptom assessment with referral for elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a more intensive intervention adding SMSH to Telephone Interpersonal Counselling (TIP-C). After 4 weeks, non-responders to SMSH alone on depression will be re-randomized to continue SMSH for 8 more weeks to allow for symptom resolution, or TIP-C will be added for the remaining 8 weeks. Specific Aims:

1. Test the effects of interventions on summed index of severity of 15 post-chemotherapy symptoms (primary outcome) and symptom-specific responses and times to response (secondary outcomes). Hypothesis 1.Survivors that starts with TIP-C+SMSH versus those that start with SMSH alone created by the first randomization will have better primary and secondary outcomes at weeks 1-13. Hypothesis 2. Among nonresponders to the SMSH alone after 4 weeks, survivors in TIP-C+SMSH as compared to the SMSH alone group created by the second randomization will have better primary and secondary outcomes at weeks 5-13.

Hypothesis 3. Self-efficacy and social support will mediate improvements in the primary outcome at week 13.

Aim 2. Compare symptom outcomes of intervention sequences against the benchmark low need group.

Exploratory Aim. Explore which survivor characteristics are associated with responses to the SMSH alone during weeks 1-4 and optimal symptom outcomes during weeks 1-13. This will allow us to determine tailoring variables to inform decision rules for choosing intervention sequences for individual survivors in the future.


Clinical Trial Description

Nearly 15.5 million Americans have survived cancer and virtually all have experienced symptoms from cancer treatment. Numerous symptom management interventions have been tested during active treatment, yet few have addressed the continuing fatigue, pain, depression, etc. that endure following the end of treatment.

Existing post-treatment symptom management research has targeted survivors months after the end of active treatment, overlooking the immediate post-treatment period. During this period, some survivors have their symptoms resolve naturally (low need for intervention), while others suffer from high symptom burden (high need for intervention), with 30% experiencing depression. Sample: The sample will be 344 ethnically diverse (at least 30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression and co-morbid illnesses.

Design: The SMART design incorporates two interventions with proven efficacy and addresses heterogeneity of survivors' responses by following the clinical logic of starting with one intervention, assessing its success, and continuing it when effective. High need survivors will be initially randomized to receive 1) weekly symptom assessment with referral for elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a more intensive intervention adding SMSH to Telephone Interpersonal Counselling (TIP-C). After 4 weeks, non-responders to SMSH alone on depression will be re-randomized to continue SMSH for 8 more weeks to allow for symptom resolution, or TIP-C will be added for the remaining 8 weeks. Specific Aims:

1. Test the effects of interventions on summed index of severity of 15 post-chemotherapy symptoms (primary outcome) and symptom-specific responses and times to response (secondary outcomes). Hypothesis 1.Survivors that starts with TIP-C+SMSH versus those that start with SMSH alone created by the first randomization will have better primary and secondary outcomes at weeks 1-13. Hypothesis 2. Among nonresponders to the SMSH alone after 4 weeks, survivors in TIP-C+SMSH as compared to the SMSH alone group created by the second randomization will have better primary and secondary outcomes at weeks 5-13.

Hypothesis 3. Self-efficacy and social support will mediate improvements in the primary outcome at week 13.

Aim 2. Compare symptom outcomes of intervention sequences against the benchmark low need group.

Exploratory Aim. Explore which survivor characteristics are associated with responses to the SMSH alone during weeks 1-4 and optimal symptom outcomes during weeks 1-13. This will allow us to determine tailoring variables to inform decision rules for choosing intervention sequences for individual survivors in the future.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Active, not recruiting NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Recruiting NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Enrolling by invitation NCT02565004 - Clinical and Laboratory Analysis of Familial Cancer N/A
Completed NCT01340846 - A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors Phase 1
Active, not recruiting NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center N/A
Recruiting NCT03247309 - TCR-engineered T Cells in NSCLC and HNSCC Patients (ACTengine) Phase 1
Recruiting NCT03272880 - Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers N/A
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer N/A
Completed NCT03503838 - A Pilot Study of Online Yoga for MPN Patients N/A
Active, not recruiting NCT00984035 - Investigation of Cisplatin-Related Kidney Toxicity N/A
Completed NCT01447186 - Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men N/A
Not yet recruiting NCT03257969 - Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors N/A
Recruiting NCT02883699 - Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study N/A
Recruiting NCT02869802 - Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis N/A
Active, not recruiting NCT02891993 - Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer N/A