Post-chemotherapy Symptom Management SMART

• Sponsor: University of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT03494166
• Collaborator: Michigan State University (Other)
• Enrollment: 498
• Locations: 2
• Arms: 3
• Actual Duration (Months): 47.1
• Patients Per Site: 249
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Telephone Interpersonal Counseling (TIP-C)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 498 participants
• 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.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
• Official Title: Post-chemotherapy Symptom Management: Testing Intervention Sequences in a SMART Design
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Jun 3, 2022
• Actual Study Completion Date: Jun 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Telephone Interpersonal Counseling (TIP-C); See arm/group descriptions; Other Names: Symptom Management Handbook (SMH)
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.	Behavioral: Telephone Interpersonal Counseling (TIP-C); See arm/group descriptions; Other Names: Symptom Management Handbook (SMH)

Outcome Measures

Primary Outcome Measures

1. Symptoms [Weekly for 13 weeks]

   Assessment of common cancer symptoms such as fatigue, depression, etc.

Secondary Outcome Measures

1. Depression [Week 13]

   Measured using Center for Epidemiological Studies-Depression (CES-D)

2. Social Support [13 weeks]

   Patient-Reported Outcomes Measurement Information System (PROMIS)-8 item informational and emotional support scales

3. Self-efficacy [13 weeks]

   PROMIS cancer self-efficacy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center at St. Joseph's	Phoenix	Arizona	United States	85004
2	University of Arizona	Tucson	Arizona	United States	85721

Sponsors and Collaborators

• University of Arizona
• Michigan State University

Investigators

• Principal Investigator: Terry Badger, PhD, University of Arizona

Study Documents (Full-Text)

• Informed Consent Form - Dec 14, 2021

More Information

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT03494166
• Other Study ID Numbers: 1711069340
• First Posted: Apr 11, 2018
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 11, 2022