Telephone Symptom Monitoring for Cancer

(SYMON Trial)

Recruiting at 28 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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Telephone Symptom Monitoring treatment for cancer patients?

Research shows that both nurse-assisted and automated telephone symptom management can significantly reduce symptom severity in cancer patients undergoing chemotherapy. Additionally, rapid access to clinicians via telephone can improve treatment compliance and reduce unnecessary emergency visits. ^{1 2 3 4 5}

Is telephone symptom monitoring safe for cancer patients?

Telephone symptom monitoring, including methods like Automated Telephone Symptom Management (ATSM), has been used safely in cancer patients to help manage symptoms. Studies show it supports treatment compliance and reduces unnecessary emergency visits, with no significant safety concerns reported. ^{1 2 4 6 7}

How is the Telephone Symptom Monitoring treatment for cancer different from other treatments?

The Telephone Symptom Monitoring treatment is unique because it uses automated phone calls to help manage symptoms, allowing patients to report and receive guidance on their symptoms without needing to visit a clinic. This approach can be more convenient and accessible for patients, especially those who may have difficulty traveling to appointments. ^{1 2 4 8 9}

Research Team

Alla Sikorskii

Principal Investigator

NRG Oncology

Eligibility Criteria

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

I treat at least 40 patients a year with oral therapy who meet specific study criteria.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Analysis of Unscheduled Telephone Calls Received by a Specialized Cancer Pain Nurse. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Symptom management for cancer patients: a trial comparing two multimodal interventions. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Managing symptoms among patients with breast cancer during chemotherapy: results of a two-arm behavioral trial. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Patient and family experiences with accessing telephone cancer treatment symptom support: a descriptive study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Pain Assessment with Short Message Service and Interactive Voice Response in Outpatients with Cancer and Pain: A Feasibility Study. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Remote symptom support training programs for oncology nurses in Canada: an environmental scan. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of a phone-based nurse monitoring assessment and intervention for chemotherapy-related toxicity: A randomized multicenter trial. [2022]

8. United States 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. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Remote System for Daily Symptom Monitoring During Systemic Anticancer Treatment: Patient Acceptance, Usability, and Compliance. [2022]