Trial Title:
Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
NCT ID:
NCT06279013
Condition:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Cluster randomized
Primary purpose:
Health Services Research
Masking:
Single (Outcomes Assessor)
Masking description:
Interviewers will be blinded to the study arm; IVR is automated.
Intervention:
Intervention type:
Other
Intervention name:
Counseling
Description:
Receive TIPC
Arm group label:
Arm II - Automated Telephone Symptom Management (ATSM), TIPC
Other name:
Counseling Intervention
Intervention type:
Behavioral
Intervention name:
Health Education
Description:
Receive handbook
Arm group label:
Arm II - Automated Telephone Symptom Management (ATSM), TIPC
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Arm I - Interactive Voice Response (IVR) Monitoring
Arm group label:
Arm II - Automated Telephone Symptom Management (ATSM), TIPC
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Ancillary studies
Arm group label:
Arm I - Interactive Voice Response (IVR) Monitoring
Arm group label:
Arm II - Automated Telephone Symptom Management (ATSM), TIPC
Other name:
Chart Review
Intervention type:
Other
Intervention name:
Monitoring
Description:
Receive IVR symptom monitoring
Arm group label:
Arm I - Interactive Voice Response (IVR) Monitoring
Arm group label:
Arm II - Automated Telephone Symptom Management (ATSM), TIPC
Other name:
monitor
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I - Interactive Voice Response (IVR) Monitoring
Arm group label:
Arm II - Automated Telephone Symptom Management (ATSM), TIPC
Summary:
In this clinical trial, symptom monitoring (interactive voice response [IVR] is compared
to automated telephone symptom management [ATSM] and telephone interpersonal counseling
[TIPC]) for reducing symptom burden and psychological distress (depressive and anxiety
symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one
driver of treatment interruptions and unscheduled health services use. To reduce the risk
of these events, symptom monitoring and management are necessary. However, these services
are not implemented routinely, especially in the community oncology settings. Further,
depressive and anxiety symptoms are a key barrier to enacting symptom self-management
strategies. IVR is a form of symptom monitoring where patients, when called, enter their
symptom ratings over the phone. Their symptom summary is sent to their provider, and
patients may be advised to reach out to their oncology provider, based on their symptoms.
The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship
educational handbook with self-management strategies. Patients receiving ATSM enter their
symptom ratings over the phone and have their symptoms reported to their provider, but
patients are also directed to the handbook for strategies to manage elevated symptoms.
Patients receiving ATSM who report being anxious, discouraged, or sad will also receive
TIPC, which targets psychological distress and its connection to social support and
interpersonal communication. Information gathered from this study may help researchers
learn more about the best ways to manage patient symptoms and improve patient outcomes.
Detailed description:
PRIMARY OBJECTIVE:
I. Test the effectiveness of Automated Telephone System Management (ATSM) + Telephone
Interpersonal Counseling (TIPC) versus active control on patient-level outcome of the
summary toxicity index of 24 Patient Reported Outcomes Common Terminology Criteria for
Adverse Events (PRO-CTCAE) symptoms that include depressive, anxiety, and other symptoms
commonly experienced during oral anti-cancer treatment over weeks 1-12 (immediate effect)
and 13-17 (sustained effect).
SECONDARY OBJECTIVE:
I. Test the effectiveness of ATSM+TIPC versus active control on patient-level outcome of
unscheduled health services over weeks 1-12 and 13-17.
EXPLORATORY OBJECTIVES:
I. Evaluate implementation outcomes at the practice personnel level (physicians, nurses,
nurse practitioners, advanced practice providers, physician assistants, medical
assistants, pharmacists, social workers, and other behavioral health professionals):
Ia. Feasibility as reflected by practice personnel attitudes toward symptom management
and time to address weekly IVR symptom reports; Ib. Practice personnel's actions on
symptom reports (symptom-related oncology visits, oral agent treatment alterations,
prescriptions of supportive care medications, referrals to supportive care services); Ic.
Treatment fidelity of TIPC delivered by social workers/counselors in the ATSM+TIPC arm
and time spent by them; Id. Perceptions of intervention acceptability and appropriateness
for the community oncology practice.
II. Estimate delivery cost of the ATSM+TIPC and active control and cost savings for the
ATSM+TIPC versus active control as a result of reduced unscheduled health services use.
III. Estimate the effect of the ATSM+TIPC versus active control on patient-reported
financial burden.
OUTLINE: Practices are randomized to 1 of 2 arms.
ARM I: Patients receive IVR symptom monitoring calls once a week for 12 weeks, and a
summary symptom report is sent to their provider. Call duration is approximately 15
minutes.
ARM II: Patients receive the Symptom Management and Survivorship handbook and receive IVR
symptom monitoring calls for 12 weeks, with summary symptom reports sent to their
provider. Call duration is approximately 20 minutes. Patients who report anxious,
discouraged, or sad mood items on their monitoring calls for two consecutive weeks
between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is
approximately 30 minutes.
After completion of study intervention, patients are followed up during weeks 13-17 and
practice personnel are assessed at intake and 2 and 25 months later.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- PRACTICES: All institutions participating in the practice are National Cancer
Institute Community Oncology Research Program (NCORP) affiliates or sub-affiliates.
- PRACTICES: Administer oral therapy to at least 40 patients per year that meet
protocol eligibility criteria.
- PRACTICES: Completion and submission of the NRG-CC012CD Letter of Intent (LOI)
(posted on the Cancer Trials Support Unit [CTSU] website).
- PRACTICES: Having a social worker licensed in behavioral counseling or other person
eligible for behavioral licensing in the practice's State or Territory (if licensure
is required by State or Territory) who can be trained to deliver TIPC or willingness
of practice to work with TIPC intervener obtained by the study team.
- PRACTICE PERSONNEL: Age ≥ 18 years.
- PRACTICE PERSONNEL: Planned to be involved in usual care for at least one enrolled
patient during patient's participation in the study.
- PRACTICE PERSONNEL: For a social worker or other behavioral health professional who
will deliver TIPC intervention, licensure, or eligibility for licensure in
behavioral counseling if required by the State or Territory.
- PRACTICE PERSONNEL: The practice personnel must provide study-specific informed
consent prior to study entry.
- RETAIN PRACTICE PARTICIPATION: In order to maintain participation in the study,
practices must enroll at least 8 patients in the first 6 months (based upon the
practice's monthly tracking reports) the practice is open to patient accrual to
ensure that the practice can meet the accrual goals. If a practice does not meet
this criterion they will be replaced.
- RETAIN PRACTICE PARTICIPATION: Complete monthly forms on actions taken on IVR
symptom reports. If fewer than 2 forms are completed in the first 6 months of
practice's participation, practice will be replaced.
- RETAIN PRACTICE PARTICIPATION: Participate in monthly study calls for the duration
of practice's participation in the study.
- PATIENTS: Starting a new course of an oral anti-cancer agent (the list of agents is
posted to the CTSU website) other than sex hormone inhibitors, within 4 weeks after
registration or have started an oral anti-cancer agent in the past 4 weeks.
- PATIENTS: All concomitant medications and supportive care treatments are acceptable.
- PATIENTS: Age ≥ 18 years.
- PATIENTS: Able to speak and understand English or Spanish.
- PATIENTS: Access to a telephone and ability to answer questions via telephone in
English or Spanish.
- PATIENTS: The patient must provide study-specific informed consent prior to study
entry and authorization permitting release of personal health information.
Exclusion Criteria:
- PRACTICES: Active telephone symptom management program at the practice that is
beyond symptom and oral agent adherence monitoring.
- PATIENTS: Current treatment with immune checkpoint inhibitor.
- PATIENTS: Only receiving treatment with sex hormone inhibitors.
- PATIENTS: Enrollment in the intervention arm of another symptom management trial at
intake into the trial. Participation in lifestyle trials with primary outcomes other
than symptoms is acceptable.
- PATIENTS: Currently receiving regular behavioral counseling for psychological
symptoms. Regular behavioral counseling is defined as at least two counseling
sessions with a behavioral health care provider scheduled within the past two
months. Patients who completed behavioral counseling within 2 months prior to
registration are eligible. Behavioral counseling for issues other than psychological
symptoms (e.g., as part of weight loss or smoking cessation program) is not an
exclusion criterion.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Carle at The Riverfront
Address:
City:
Danville
Zip:
61832
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@Carle.com
Investigator:
Last name:
Vamsi K. Vasireddy
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Effingham
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Vamsi K. Vasireddy
Email:
Principal Investigator
Facility:
Name:
Carle Physician Group-Mattoon/Charleston
Address:
City:
Mattoon
Zip:
61938
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Vamsi K. Vasireddy
Email:
Principal Investigator
Facility:
Name:
Carle Cancer Center
Address:
City:
Urbana
Zip:
61801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-446-5532
Email:
Research@carle.com
Investigator:
Last name:
Vamsi K. Vasireddy
Email:
Principal Investigator
Facility:
Name:
Langlade Hospital and Cancer Center
Address:
City:
Antigo
Zip:
54409
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-623-9869
Email:
Juli.Alford@aspirus.org
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Medford Hospital
Address:
City:
Medford
Zip:
54451
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-847-2353
Email:
Beth.Knetter@aspirus.org
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Ascension Saint Mary's Hospital
Address:
City:
Rhinelander
Zip:
54501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-847-2353
Email:
Beth.Knetter@aspirus.org
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Ascension Saint Michael's Hospital
Address:
City:
Stevens Point
Zip:
54481
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-847-2353
Email:
Beth.Knetter@aspirus.org
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Regional Cancer Center
Address:
City:
Wausau
Zip:
54401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-405-6866
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Facility:
Name:
Aspirus Cancer Care - Wisconsin Rapids
Address:
City:
Wisconsin Rapids
Zip:
54494
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
715-422-7718
Investigator:
Last name:
Andrew J. Huang
Email:
Principal Investigator
Start date:
May 20, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
NRG Oncology
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
NRG Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279013
