Post-chemotherapy Symptom Management SMART

NCT03494166 | Completed Results DMC

• 2 other identifiers: 1711069340R01CA225615
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 2

Brief 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

Cancer

Keywords

Chemotherapy, symptom management

Outcome Measures

Primary Outcomes (2)

• Symptom Severity Index- Comparison of Two Groups Created by First Randomization

  Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated the severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 1-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, with higher score indicating worse outcome (greater severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.

  Weeks 1-13

• Symptom Severity Index- Comparison of Two Groups Created by Second Randomization

  Symptoms were measured using the modified General Symptom Distress Scale (GSDS) allowing for a quick assessment of 18 symptoms: fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated severity of each symptom (0 = not present to 10 = worst possible). A summed symptom severity index for 17 symptoms other than depression was averaged over weeks 5-13 from each weekly contact, baseline, and 13-week interviews. Potential range 0-170, higher value reflect worse outcome (greater symptom severity). Because the collection of symptoms does not form a scale, internal consistency reliability was not applicable.

  Weeks 5-13

Secondary Outcomes (2)

• Depressive Symptoms- Comparison of Two Groups Created by First Randomization.

  Week 13

• Depressive Symptoms - Comparison of Two Groups Created by Second Randomization

  Week 13

Study Arms (3)

Low Need Benchmark or Follow-up

NO INTERVENTION

In the low need benchmark or follow-up group, survivors completed detailed baseline and 13-week assessments (about 30-40 minutes) over the telephone. A brief assessment (about 5 minutes) at week 4 over the telephone was used to assess symptoms.

High Need A: Start with SMSH alone for 4 weeks

EXPERIMENTAL

Participants were mailed the printed Symptom Management and Survivorship Handbook (SMH). The Group A participant was called every week for 4 weeks to ask about symptoms and suggest strategies from the SMH to relieve symptoms. After 4 weeks, participants were re-randomized to continue in SMH for 8 more weeks or to add Telephone Interpersonal Counseling (TIPC) Intervention for the subsequent 8 weeks. If the TIPC was added, the counselor called the participant once per week for about 35-40 minutes to assess and discuss interpersonal relationships, communication, social support, managing symptoms and survivorship. At week 13, the participant completed the second assessment.

Behavioral: Start with SMSH alone

High Need B: Start with SMSH+TIPC

EXPERIMENTAL

Participants were called every week for the first 8 weeks using a combination of TIP-C and SMH. The counselor called to assess and discuss interpersonal relationships, communication, social support, managing symptoms and survivorship. At the end of 8 weeks, the final 4 calls followed the SMSH alone protocol. At week 13, the second assessment was conducted.

Behavioral: Start with SMSH+TIPC

Interventions

Start with SMSH+TIPC BEHAVIORAL

See arm/group descriptions

High Need B: Start with SMSH+TIPC

Start with SMSH alone BEHAVIORAL

See arm/group descriptions

High Need A: Start with SMSH alone for 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older
• Have access to a telephone
• Understand English or Spanish
• Are not currently receiving counseling and/or psychotherapy

You may not qualify if:

• Diagnosis of a psychotic disorder in medical record verified by the recruiter
• Nursing home resident
• Bedridden
• Currently receiving counseling and/or psychotherapy.

Sponsors & Collaborators

• University of Arizona: lead
• Michigan State University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Cancer Center at St. Joseph's

Phoenix, Arizona, 85004, United States

Location

University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Publications (1)

• Sikorskii A, Badger T, Segrin C, Crane TE, Chalasani P, Arslan W, Hadeed M, Morrill KE, Given C. A Sequential Multiple Assignment Randomized Trial of Symptom Management After Chemotherapy. J Pain Symptom Manage. 2023 Jun;65(6):541-552.e2. doi: 10.1016/j.jpainsymman.2023.02.005. Epub 2023 Feb 17.

  PMID: 36801353 RESULT

MeSH Terms

Conditions

Neoplasms

Limitations and Caveats

The larger than anticipated proportion of high need survivors resulted in a larger sample size for tests of hypotheses associated with first randomization. The higher than anticipated response rate to the SMSH at week 4 resulted in a lower number of survivors in the second randomization compared to the requirements of power analysis. On the other hand, a higher than anticipated rate of response to the SMSH alone led to a larger than planned number of responders.

Results Point of Contact

• Title: Terry Badger, PhD (MPI) and Alla Sikorskii, PhD (MPI)
• Organization: University of Arizona College of Nursing

tbadger@arizona.edu

520-626-6058

Study Officials

• Terry Badger, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors will be blinded to the arm of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 SMSH, 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.

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 11, 2018
• Study Start: July 1, 2018
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: October 19, 2023
• Results First Posted: October 19, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (2)