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Can phone Check-Ins ease cancer treatment side effects?

NCT ID NCT06279013

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • AnMed Health Cancer Center

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Aspirus Cancer Care - James Beck Cancer Center

    RECRUITING

    Rhinelander, Wisconsin, 54501, United States

  • Aspirus Cancer Care - Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54481, United States

  • Aspirus Cancer Care - Wisconsin Rapids

    RECRUITING

    Wisconsin Rapids, Wisconsin, 54494, United States

  • Aspirus Medford Hospital

    RECRUITING

    Medford, Wisconsin, 54451, United States

  • Aspirus Regional Cancer Center

    RECRUITING

    Wausau, Wisconsin, 54401, United States

  • Augusta Oncology Associates PC-D'Antignac

    SUSPENDED

    Augusta, Georgia, 30901, United States

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • CARTI Cancer Center

    RECRUITING

    Little Rock, Arkansas, 72205, United States

    Contact Email: •••••@•••••

  • Cancer Center at Saint Joseph's

    RECRUITING

    Phoenix, Arizona, 85004, United States

    Contact Email: •••••@•••••

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Central Care Cancer Center - Garden City

    RECRUITING

    Garden City, Kansas, 67846, United States

  • Centro Comprensivo de Cancer de UPR

    RECRUITING

    San Juan, 00927, Puerto Rico

  • Doctors Cancer Center

    RECRUITING

    Manati, 00674, Puerto Rico

  • John H Stroger Jr Hospital of Cook County

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Lake Regional Hospital

    RECRUITING

    Osage Beach, Missouri, 65065, United States

    Contact Email: •••••@•••••

  • Langlade Hospital and Cancer Center

    RECRUITING

    Antigo, Wisconsin, 54409, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • PROncology

    RECRUITING

    San Juan, 00927, Puerto Rico

    Contact Email: •••••@•••••

  • Phoebe Putney Memorial Hospital

    SUSPENDED

    Albany, Georgia, 31701, United States

  • Prisma Health Cancer Institute - Butternut

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Eastside

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Prisma Health Cancer Institute - Faris

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Prisma Health Greenville Memorial Hospital

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Puerto Rico Hematology Oncology Group

    RECRUITING

    Bayamón, 00961, Puerto Rico

  • Queen's Cancer Cenrer - POB I

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • Queen's Cancer Center - Kuakini

    RECRUITING

    Honolulu, Hawaii, 96817, United States

  • Queen's Medical Center

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • The Queen's Medical Center - West Oahu

    RECRUITING

    ‘Ewa Beach, Hawaii, 96706, United States

  • University Medical Center New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

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