Telephone Symptom Monitoring for Cancer

(SYMON Trial)

Recruiting at 37 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NRG Oncology

Must be taking: Oral anti-cancer agents

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Pregnancy, Behavioral counseling, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce symptoms and psychological distress, such as anxiety and depression, in individuals taking oral cancer medications. It compares three approaches: a basic phone check-in system (Interactive Voice Response, IVR), an enhanced version with self-help resources (Automated Telephone Symptom Management, ATSM), and targeted counseling calls for those experiencing distress (Telephone Interpersonal Counseling, TIPC). Individuals who have started a new oral cancer treatment within the last 8 weeks and have phone access might be suitable candidates. The information gathered may improve symptom management during cancer treatment. As an unphased trial, this study provides an opportunity to contribute to innovative approaches in managing cancer treatment symptoms.

Will I have to stop taking my current medications?

The trial allows all current medications and supportive care treatments, so you won't need to stop taking your current medications.

What prior data suggests that these telephone symptom monitoring interventions are safe for cancer patients?

Research shows that phone-based methods for tracking symptoms are generally easy for patients to use. Studies have found that an interactive voice response (IVR) system, where patients report symptoms by phone, is safe and improves communication with healthcare providers. Patients express satisfaction with these systems because they manage symptoms more effectively. Another study found that automated phone options like ATSM and TIPC positively affect patients' physical and mental health, enhancing their quality of life and self-care. No significant reports of negative effects have emerged from using these methods, making them a safe choice for managing symptoms during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telephone Symptom Monitoring interventions for cancer patients because these methods offer a proactive approach to managing symptoms. Unlike traditional treatments that typically require in-person visits, this approach uses Interactive Voice Response (IVR) calls to regularly monitor patients’ symptoms from home. This can help catch and address issues early, potentially improving patient outcomes and quality of life. Additionally, for those showing signs of emotional distress, the trial includes tailored Telephone Interpersonal Counseling (TIPC) calls, adding a personalized support layer to the treatment. This combination of remote monitoring and personalized care could significantly enhance how cancer patients manage their symptoms and overall well-being.

What evidence suggests that these telephone symptom monitoring interventions could be effective for reducing symptom burden and psychological distress in cancer patients?

Research has shown that interactive voice response (IVR) systems can help cancer patients manage their symptoms. In this trial, participants in Arm I will receive IVR symptom monitoring calls. Studies have found that patients using IVR reported better quality of life and fewer symptoms. Arm II of this trial involves ATSM, which combines IVR with educational materials to help patients manage their symptoms more effectively, showing promise in improving overall patient outcomes. For those dealing with emotional distress, Arm II also includes telephone interpersonal counseling (TIPC), which has effectively reduced depression, fatigue, and stress while increasing positive feelings. These interventions aim to reduce disruptions and healthcare visits caused by untreated symptoms, making cancer treatments easier to handle. ^{4 6 7 8 9}

Who Is on the Research Team?

Alla Sikorskii

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for practices administering oral cancer therapy to at least 40 patients yearly, affiliated with NCORP. Involved personnel must be adults who consent to the study and can include a licensed social worker or equivalent for counseling. Practices must enroll 8 patients in 6 months and act on IVR reports.

Inclusion Criteria

All institutions participating in the practice are National Cancer Institute Community Oncology Research Program (NCORP) affiliates or sub-affiliates

Study-specific informed consent provided by practice personnel prior to study entry

Completion and submission of the NRG-CC012CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit [CTSU] website)

Exclusion Criteria

Enrollment in the intervention arm of another symptom management trial at intake into the trial for patients

My healthcare provider offers a comprehensive phone-based symptom management program.

I am currently in or recently completed psychological counseling.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IVR symptom monitoring calls once a week for 12 weeks, with summary symptom reports sent to their provider. In Arm II, participants also receive the Symptom Management and Survivorship handbook and may receive TIPC calls if needed.

12 weeks

Weekly calls

Follow-up

Participants are monitored for sustained effects and unscheduled health services use after the treatment phase

5 weeks

Long-term follow-up

Practice personnel are assessed for feasibility, acceptability, and appropriateness of the interventions, and cost analysis is conducted

Up to 25 months

What Are the Treatments Tested in This Trial?

Interventions

• Telephone Symptom Monitoring Interventions

Trial Overview The trial compares three methods of symptom monitoring: IVR, ATSM with an educational handbook, and TIPC targeting psychological distress. It aims to reduce symptoms and distress in those undergoing oral anti-cancer treatment by evaluating different support strategies.

How Is the Trial Designed?

Group I: Arm II (ATSM, TIPC) Experimental Treatment 6 Interventions

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.

Group II: Arm I (IVR monitoring) Active Control 4 Interventions

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.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A nationwide trial involving adult cancer patients receiving adjuvant chemotherapy showed that weekly phone-based nurse monitoring significantly reduced the time spent experiencing severe toxicities (grade ≥3), particularly for less commonly reported issues like fatigue.

Patients who received the nurse monitoring intervention also experienced shorter durations of mild to moderate adverse events, such as diarrhea and mucositis, indicating that proactive monitoring can enhance the management of chemotherapy-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a phone-based nurse monitoring assessment and intervention for chemotherapy-related toxicity: A randomized multicenter trial. Antonuzzo, A., Ripamonti, CI., Roila, F., et al.[2022]

A survey of 28 oncology programs across Canada revealed that while most offer telephone symptom support, only 17 provide training for nurses, highlighting variability in training practices.

The training materials shared included important elements like symptom management guidelines and communication skills, but none of the programs had undergone rigorous evaluation, indicating a need for standardized training and assessment of its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote symptom support training programs for oncology nurses in Canada: an environmental scan. Stacey, D., Carley, M., Kohli, J., et al.[2022]

Out of 465 patients starting systemic cancer treatment, 51.4% expressed interest in using a remote system for daily symptom monitoring, indicating a good level of acceptance for this technology.

The system demonstrated a compliance rate of 68.8% in the first 3 weeks and 59.1% by 12 weeks, suggesting that daily monitoring is feasible; however, many patients felt their reports were not adequately utilized by healthcare providers, highlighting an area for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote System for Daily Symptom Monitoring During Systemic Anticancer Treatment: Patient Acceptance, Usability, and Compliance. Coolbrandt, A., Muylaert, K., Vandeneede, E., et al.[2022]

A study analyzing 102 unscheduled phone calls to a cancer pain clinic found that 74% of calls were made by patients or caregivers, primarily to report symptoms or treatment concerns, with pain being the most common issue reported (59.6%).

The cancer pain nurse effectively managed 87.3% of these calls without needing a doctor, providing interventions that included treatment adjustments and patient education, highlighting the importance of telephone consultations in improving patient care and reducing unnecessary emergency department visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Unscheduled Telephone Calls Received by a Specialized Cancer Pain Nurse. Remy, C., Borniard, J., Perez, J.[2021]

In a study involving 435 cancer patients undergoing chemotherapy, both nurse-assisted symptom management (NASM) and automated telephone symptom management (ATSM) significantly reduced symptom severity, showing that both methods are effective for managing symptoms during treatment.

While both interventions were effective, NASM appeared to be better at keeping lung cancer patients engaged in the program, suggesting that combining ATSM with NASM could be beneficial for patients experiencing severe symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom management for cancer patients: a trial comparing two multimodal interventions. Sikorskii, A., Given, CW., Given, B., et al.[2018]

A feasibility study involving 13 cancer patients showed that using interactive voice response (IVR) and SMS for daily pain assessment was effective and well-received, with no issues reported by the mainly older participants.

The intervention led to a significant reduction in pain scores, with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pain scale decreasing from 56 to 35, indicating improved pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Assessment with Short Message Service and Interactive Voice Response in Outpatients with Cancer and Pain: A Feasibility Study. Besse, KT., Faber-te Boveldt, ND., Janssen, GH., et al.[2022]

A study involving 105 patients and family members showed that 90% received helpful advice through telephone support for cancer treatment symptoms, with a high satisfaction rate regarding the care provided by nurses and doctors.

Participants suggested improvements for the service, including shorter callback times, weekend availability, and better education on self-care strategies, indicating areas where the support system could be enhanced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and family experiences with accessing telephone cancer treatment symptom support: a descriptive study. Stacey, D., Green, E., Ballantyne, B., et al.[2021]

The Automated Telephone Symptom Management (ATSM) intervention was found to be more effective than the cognitive behavioral approach for patients with metastatic breast cancer, leading to greater symptom responses in shorter time frames.

Patients receiving single-agent chemotherapy experienced better symptom responses and quicker times to response compared to those on combination chemotherapy, highlighting the importance of treatment type in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing symptoms among patients with breast cancer during chemotherapy: results of a two-arm behavioral trial. Given, CW., Sikorskii, A., Tamkus, D., et al.[2022]

The Chemotherapy Telephone Helpline (CTH) received 7498 calls in 2007, with a significant portion (25.6%) occurring outside regular hours, indicating a strong demand for after-hours support for patients undergoing chemotherapy.

The service effectively connected 36.8% of callers to medical assessments, highlighting its role in providing timely access to specialist care and support for patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility, caller, and patient profile of a novel Chemotherapy Telephone Helpline service within a regional cancer centre in Northern Ireland. Reid, J., Porter, S.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06279013?term=nrg-cc012cd&rank=1

Comparing Telephone Symptom Monitoring Interventions ... 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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12238826/

Digital Patient–Reported Cancer Symptom Management Participants reported daily on the presence and severity of 11 common disease and treatment‐related symptoms using interactive voice response ( ...

3. trialx.com trialx.com/clinical-trials/listings/296436/comparing-telephone-symptom-monitoring-interventions-for-managing-symptoms-and-psychological-distress-during-oral-anti-cancer-treatment/

Comparing Telephone Symptom Monitoring Interventions ... IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223247/

Effectiveness of symptom monitoring on electronic patient ... The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.

5. ons.org ons.org/publications-research/onf/47/6/satisfaction-interactive-voice-response-system-and-symptom

Satisfaction With an Interactive Voice Response System ... This system allows patients to monitor symptoms daily, provides symptom management coaching, alerts the oncology provider if symptoms meet a specific threshold, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06279013?term=AREA%5BBasicSearch%5D(NRG-CC012CD)&rank=1

Comparing Telephone Symptom Monitoring Interventions ... In this clinical trial, symptom monitoring (interactive voice response [IVR] is compared to automated telephone symptom management [ATSM] and telephone ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/463655

Comparing Telephone Symptom Monitoring Interventions for ... IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40408610/

Impact of Providing an Automated Telephone Option to ... We compared patients choosing IVR versus web on alert rates to nurses and clinical outcomes to determine if a telephone option can close disparities in symptom ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S146238892300162X

An integrative review of adult cancer patients' experiences ... Evaluation of telephone triage systems suggests positive impacts on physical and psychological symptoms, quality of life and self-care outcomes (Cetin et al., ...