Can phone Check-Ins ease cancer treatment side effects?
NCT ID NCT06279013
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study tests whether regular phone check-ins and counseling can help people on oral cancer drugs feel better and avoid hospital visits. 600 patients will be assigned to symptom monitoring alone, or monitoring plus a self-help handbook and phone counseling for anxiety or sadness. The goal is to reduce symptom burden and emotional distress.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- symptom monitoring and counseling
- What this could lead to
- If successful, this could provide a practical way to help patients manage side effects and emotional distress during oral cancer treatment.
- What could go wrong
- This is a behavioral study, not a drug trial, so it won't directly treat the cancer. Results may vary across different practices and patient groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
34 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
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Locations
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AnMed Health Cancer Center
RECRUITINGAnderson, South Carolina, 29621, United States
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Aspirus Cancer Care - James Beck Cancer Center
RECRUITINGRhinelander, Wisconsin, 54501, United States
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Aspirus Cancer Care - Stevens Point
RECRUITINGStevens Point, Wisconsin, 54481, United States
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Aspirus Cancer Care - Wisconsin Rapids
RECRUITINGWisconsin Rapids, Wisconsin, 54494, United States
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Aspirus Medford Hospital
RECRUITINGMedford, Wisconsin, 54451, United States
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Aspirus Regional Cancer Center
RECRUITINGWausau, Wisconsin, 54401, United States
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Augusta Oncology Associates PC-D'Antignac
SUSPENDEDAugusta, Georgia, 30901, United States
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Augusta University Medical Center
RECRUITINGAugusta, Georgia, 30912, United States
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CARTI Cancer Center
RECRUITINGLittle Rock, Arkansas, 72205, United States
Contact Email: •••••@•••••
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Cancer Center at Saint Joseph's
RECRUITINGPhoenix, Arizona, 85004, United States
Contact Email: •••••@•••••
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Carle Cancer Center
RECRUITINGUrbana, Illinois, 61801, United States
Contact Email: •••••@•••••
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Carle Physician Group-Effingham
RECRUITINGEffingham, Illinois, 62401, United States
Contact Email: •••••@•••••
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Carle Physician Group-Mattoon/Charleston
RECRUITINGMattoon, Illinois, 61938, United States
Contact Email: •••••@•••••
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Carle at The Riverfront
RECRUITINGDanville, Illinois, 61832, United States
Contact Email: •••••@•••••
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Central Care Cancer Center - Garden City
RECRUITINGGarden City, Kansas, 67846, United States
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Centro Comprensivo de Cancer de UPR
RECRUITINGSan Juan, 00927, Puerto Rico
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Doctors Cancer Center
RECRUITINGManati, 00674, Puerto Rico
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John H Stroger Jr Hospital of Cook County
RECRUITINGChicago, Illinois, 60612, United States
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Lake Regional Hospital
RECRUITINGOsage Beach, Missouri, 65065, United States
Contact Email: •••••@•••••
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Langlade Hospital and Cancer Center
RECRUITINGAntigo, Wisconsin, 54409, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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PROncology
RECRUITINGSan Juan, 00927, Puerto Rico
Contact Email: •••••@•••••
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Phoebe Putney Memorial Hospital
SUSPENDEDAlbany, Georgia, 31701, United States
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Prisma Health Cancer Institute - Butternut
RECRUITINGGreenville, South Carolina, 29605, United States
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Prisma Health Cancer Institute - Eastside
RECRUITINGGreenville, South Carolina, 29615, United States
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Prisma Health Cancer Institute - Faris
RECRUITINGGreenville, South Carolina, 29605, United States
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Prisma Health Greenville Memorial Hospital
RECRUITINGGreenville, South Carolina, 29605, United States
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Puerto Rico Hematology Oncology Group
RECRUITINGBayamón, 00961, Puerto Rico
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Queen's Cancer Cenrer - POB I
RECRUITINGHonolulu, Hawaii, 96813, United States
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Queen's Cancer Center - Kuakini
RECRUITINGHonolulu, Hawaii, 96817, United States
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Queen's Medical Center
RECRUITINGHonolulu, Hawaii, 96813, United States
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The Queen's Medical Center - West Oahu
RECRUITING‘Ewa Beach, Hawaii, 96706, United States
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University Medical Center New Orleans
RECRUITINGNew Orleans, Louisiana, 70112, United States
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University of New Mexico Cancer Center
RECRUITINGAlbuquerque, New Mexico, 87106, United States
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