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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


NCT number NCT03494166
Study type Interventional
Source University of Arizona
Contact Paul Sandoval
Phone 520-626-6000
Email sponsor@email.arizona.edu
Status Recruiting
Phase N/A
Start date July 1, 2018
Completion date March 1, 2022

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