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Post-chemotherapy Symptom Management SMART

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494166
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE March 30, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
Symptoms [ Time Frame: Weekly for 13 weeks ]
Assessment of common cancer symptoms such as fatigue, depression, etc.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Depression [ Time Frame: Week 13 ]
    Measured using Center for Epidemiological Studies-Depression (CES-D)
  • Social Support [ Time Frame: 13 weeks ]
    Patient-Reported Outcomes Measurement Information System (PROMIS)-8 item informational and emotional support scales
  • Self-efficacy [ Time Frame: 13 weeks ]
    PROMIS cancer self-efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-chemotherapy Symptom Management SMART
Official Title  ICMJE Post-chemotherapy Symptom Management: Testing Intervention Sequences in a SMART Design
Brief 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.

Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Following baseline, symptom management need (high versus low need) will be determined. The low need group will not receive interventions, but will be followed at week 4 for a brief symptom assessment and at week 13. The high need group will be randomly assigned to either: 1) SMSH alone or 2) TIP-C+SMSH for 8 weeks followed by continued 4 weeks of SMSH alone. We will mail the SMSG, printed in the survivor's preferred language, following randomization. All high need participants will receive weekly telephone contacts during weeks 1-12 to assess symptoms, deliver the assigned intervention, and assess intervention enactment and fidelity. After the initial 4 weeks, responders on depression will continue with the SMSH only. Non-responders will re-randomized to either continue with the SMSH alone or add TIP-C. Those initially randomized to TIP-C+SMSH will not be re-randomized. Total duration of each of the three intervention sequences is 12 weeks.
Masking: Single (Outcomes Assessor)
Masking Description:
Data collectors will be blinded to the arm of the study.
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE Behavioral: Telephone Interpersonal Counseling (TIP-C)
See arm/group descriptions
Other Name: Symptom Management Handbook (SMH)
Study Arms  ICMJE
  • No Intervention: Low Need Benchmark or Follow-up
    In the low need benchmark or follow-up group, they will receive baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) at week 4 over the telephone will assess symptoms. Approximately 35% of all participants will be in this group.
  • Experimental: High Need A-SMH or TIP-C
    Participants will be mailed the printed Symptom Management and Survivorship Handbook (SMH). The Group A participant will be called every week for 4 weeks to ask about symptoms and suggest strategies from the SMH to relieve symptoms. Calls will last approximately 10 minutes. After 4 weeks, participants will be re-randomized to continue in SMH for 8 more weeks or to add Telephone Interpersonal Counseling (TIP-C) Intervention for the subsequent 8 weeks. If the TIP-C is added, the counselor will call the participant once per week for about 35-40 minutes to assess and discuss strategies for managing symptoms, provide survivorship education, and discuss interpersonal relationships, communication, and social support. At week 13, the participant will complete the second assessment.
    Intervention: Behavioral: Telephone Interpersonal Counseling (TIP-C)
  • Experimental: High Need B-TIP-C+SMH
    Participant will be called every week for the first 8 weeks using a combination of TIP-C and SMH. The counselor will assess and discuss interpersonal relationships, communication, social support, managing symptoms and survivorship. At the end of 8 weeks, the final 4 calls will focus be the SMH protocol. At week 13, the second assessment will be conducted.
    Intervention: Behavioral: Telephone Interpersonal Counseling (TIP-C)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2018)
430
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paul Sandoval 520-626-6000 sponsor@email.arizona.edu
Contact: Mary (Molly) Hadeed 5206266608 mcbarry@nursing.arizona.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494166
Other Study ID Numbers  ICMJE 1711069340
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

We will share the findings and data with other researchers, the public, and key stakeholders based on the principles that NIH has articulated regarding the sharing of study results and resources. The University of Arizona agrees that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve health.

Sharing of study results Manuscript based on results from the proposed study will be published in peer-reviewed journals. We will select "open access" options for these manuscripts whenever possible.

Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Anticipate later part of 2022
Access Criteria: Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Michigan State University
Investigators  ICMJE
Principal Investigator: Terry Badger, PhD University of Arizona
PRS Account University of Arizona
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP