Hematopoietic and Lymphatic System NeoplasmSYMONNCT06279013
Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
A study testing Counseling, Health Education and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by NRG Oncology at 34 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Counseling, Health Education and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 34 sitesin 2 countries
- Study dates
- 14 Oct 2024to 1 Jun 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 contracted by the study team. Note: If the practice's social worker or other behavioral health professional is trained to deliver TIPC, they will be compensated for their time training and delivering the TIPC intervention.
- 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.
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- 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 8 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.
Who cannot join
- PRACTICES: Active telephone symptom management program at the practice that is beyond symptom and oral agent adherence monitoring.
- 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.
- PATIENTS: Pregnancy at intake into the trial.
Trial locations and contacts
34 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 2 countries
United States30 sites, 30 recruiting
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Site Public Contact, rohta@queens.org
Karen Rowan
- Recruiting
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Site Public Contact, 229-312-0405, ga_cares@augusta.edu
Anand P. Jillella
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Harmony Bowles
- Recruiting
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Site Public Contact, 864-512-4651, rhonda.ballew@anmedhealth.org
Jay B. Nayak
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Augusta Oncology Associates PC-D'Antignac
Augusta, Georgia, 30901
Site Public Contact, 706-821-2944
Anand P. Jillella
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
Site Public Contact, 706-721-2388, ga_cares@augusta.edu
Anand P. Jillella
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Evan M. Graboyes
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M. Tamkus
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Matthew F. Hudson
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Matthew F. Hudson
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Matthew F. Hudson
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Matthew F. Hudson
- Recruiting
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Site Public Contact, 808-532-0315
Karen Rowan
- Recruiting
Queen's Medical Center
Honolulu, Hawaii, 96813
Site Public Contact, 808-545-8548
Karen Rowan
- Recruiting
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
Site Public Contact, 808-531-8521
Karen Rowan
- Recruiting
CARTI Cancer Center
Little Rock, Arkansas, 72205
Site Public Contact, 501-906-4199, Research@CARTI.com
Jay W. Carlson
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Aspirus Medford Hospital
Medford, Wisconsin, 54451
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Amelia M. Jernigan
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Aspirus Cancer Care-Wausau
Wausau, Wisconsin, 54401
Site Public Contact, 877-405-6866
Andrew J. Huang
- Recruiting
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Site Public Contact, 715-422-7718
Andrew J. Huang
Puerto Rico4 sites, 4 recruiting
- Recruiting
Puerto Rico Hematology Oncology Group
Bayamón, 00961
Site Public Contact, 787-780-2865
Luis J. Santos Reyes
- Recruiting
Doctors Cancer Center
Manati, 00674
Site Public Contact, 787-621-4397
Luis J. Santos Reyes
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Luis J. Santos Reyes
- Recruiting
PROncology
San Juan, 00927
Site Public Contact, 787-919-7919, info@PRoncology.com
Luis J. Santos Reyes
About this study
Official title: Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment (SYMON)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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 of implementation of the automated telephone symptom monitoring and TIPC at the community oncology practice.
Ib. Perceptions of acceptability of the automated telephone symptom monitoring and TIPC for the community oncology practice.
Ic. Perceptions of appropriateness of the automated telephone symptom monitoring and TIPC 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.
IV. Estimate the differences in the effect of the ATSM+TIPC versus active control on the primary and secondary outcomes according to concurrent administration of oral agent with immune checkpoint inhibitor, other targeted infusion therapy, infusion chemotherapy, or radiation therapy.
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 12 and 25 months later.
- Being tested
- Counseling, Health Education, Interview, Medical Chart Review, Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Counseling Intervention
Receive TIPC
Health EducationBehavioural
Receive handbook
InterviewOther
Ancillary studies
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
MonitoringOther
Also called monitor
Receive IVR symptom monitoring
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (IVR monitoring) | Active comparator | 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. Receives: Other: Interview; Other: Medical Chart Review; Other: Monitoring; Other: Questionnaire Administration |
| Arm II (ATSM, TIPC) | Experimental | 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. Receives: Other: Counseling; Behavioral: Health Education; Other: Interview; Other: Medical Chart Review; Other: Monitoring; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity/toxicity index
Toxicity index across 24 symptoms will be measured using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Linear mixed effects or generalized linear mixed effects models will be used.
Measured: Up to 12 weeks from the start of therapy (trial interventions)
Secondary outcomes (1)
Unscheduled health services
Questions with yes/no responses about each type of unscheduled health service use: hospitalizations, use of urgent care, use of the emergency department. If yes, number of days spent in the hospital, number of times visited urgent care or emergency department are recorded.
Measured: Up to 17 weeks from the start of therapy (trial interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start14 Oct 2024
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alla Sikorskii, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279013
- Sponsor's protocol ID
- NRG-CC012CD
- Other IDs
- NCI-2023-10831, NRG-CC012CD, NRG-CC012CD, NRG-CC012CD, R01CA279472, UG1CA189867
- Acronym
- SYMON
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No