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Compares treatment options for Hematopoietic and Lymphatic System Neoplasm
Official title Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
ClinicalTrials.gov ID: NCT06279013
What this study is testing
- What it's testing
- 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.
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- PRACTICES: All institutions participating in the practice are National Cancer Institute Community Oncology Research Program (NCORP) affiliates or...
- 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...
- PRACTICE PERSONNEL: Age ≥ 18 years.
You likely can't join if
- 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...
- PATIENTS: Currently receiving regular behavioral counseling for psychological symptoms. Regular behavioral counseling is defined as at least two...
- PATIENTS: Pregnancy at intake into the trial.
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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...
- PATIENTS: Pregnancy at intake into the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Albany, Georgia, United States
- Augusta, Georgia, United States
- Honolulu, Hawaii, United States
- ‘Ewa Beach, Hawaii, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
- Effingham, Illinois, United States
- Mattoon, Illinois, United States
- Urbana, Illinois, United States
- Garden City, Kansas, United States
- New Orleans, Louisiana, United States
- Osage Beach, Missouri, United States
- Albuquerque, New Mexico, United States
- Anderson, South Carolina, United States
- Charleston, South Carolina, United States
- Greenville, South Carolina, United States
- Antigo, Wisconsin, United States
- Medford, Wisconsin, United States
+ 7 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Albany, Georgia, United States; Augusta, Georgia, United States; Honolulu, Hawaii, United States; ‘Ewa Beach, Hawaii, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.