Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

Malignant Solid Neoplasm Clinical Trial

Official title:

Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279013
• Other study ID #: NRG-CC012CD
• Secondary ID: NCI-2023-10831NR
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 16, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: February 2024
• Source: NRG Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 516
• Est. completion date: May 1, 2028
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Counseling
Receive TIPC

Behavioral:
• Health Education
Receive handbook

Other:
• Interview
Ancillary studies
• Medical Chart Review
Ancillary studies
• Monitoring
Receive IVR symptom monitoring
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NRG Oncology	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Practice personnel time to address weekly interactive voice response (IVR) symptom reports	Practice personnel time to address weekly IVR symptom reports will be prorated by the number of patients on trial during each month within each practice and compared between the intervention (ATSM+TIPC) and active control (IVR alone) arms using monthly repeated measures for 25 months of each practice's participation. If multiple professionals are involved, data will be collected from all of them and analyzed as nested within practice. A random effect for practice will be defined if more than one practice personnel is assigned to receive IVR reports per practice. Month will be entered as a class variable to model potentially non-linear patterns, and month by trial arm interaction will be evaluated.	Up to 25 months
Other	Treatment fidelity	Treatment fidelity will be analyzed. Fidelity scores will be summarized for each TIPC interventionist. The number of elements personalized to the specific needs of the individual within the structured protocol (number of personalized elements/ total number of elements) will be examined (e.g., more discussion of socioeconomic needs with one participant versus another) and assessed by outcomes.	Up to 25 months
Other	Cost	Total costs (fixed and variable), including personnel time, fixed costs to develop software, and operating costs for the interventions will be calculated. Cost savings in each arm will be calculated using unadjusted and adjusted rates of hospitalizations and urgent care or emergency department visits based on cost data for the States where participating practices will be located.	Up to 5 years
Other	Patient financial burden	Will be explored via mixed general or generalized linear models relating Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity scores to the covariates of baseline financial toxicity score and trial arm.	Up to 17 weeks from the start of therapy (trial interventions)
Primary	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 (PRO-CTCAE). Severity is rated on a scale of 0-4 where 0 = None and 4 = Very Severe. Linear mixed effects or generalized linear mixed effects models will be used.	Up to 17 weeks from the start of therapy (trial interventions)
Secondary	Incidence of Unscheduled Health Services Usage	Generalized linear mixed effects model with Poisson distributed errors, or zero-inflated Poisson or negative Binomial model based on the distribution of the counts of different health services uses.	Up to 17 weeks from the start of therapy (trial interventions)