CancerNCT06549153
ACT-Together (Acting on Cancer Testing-Together)
A study testing Education Content and Focus Group in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To determine the feasibility of a group-based education intervention to improve adherence to recommend surveillance and risk reducing procedures, with a focus at medically underserved women and racial/ethnic minorities with BRCA 1 and 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Education Content and Focus Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis
- Arm 1: Diagnosis of MDS intermediate/high/very high risk by Revised International Prognostic Scoring System (IPSS-R), Untreated or up to 2 prior treatments.
- Arm 2: Diagnosis of relapsed/refractory AML (per European Leukemia Network 2022)[26] receiving treatment as salvage 1-2. MDS or CMML treated with hypomethylating agent (HMA) therapies who progress to AML and have no available better therapies or are not candidates for available therapies, will be eligible at the time of progression to AML.
- Patients aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- Temporary prior measures such as apheresis, limited dose cytarabine or use of hydrea while eligibility work-up is being performed are allowed and not counted as a prior salvage
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- In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks or at least 5 half-lives (whichever is shorter). The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document.
- The toxicity from prior therapy should have resolved to Grade ≤1, however alopecia and sensory neuropathy Grade ≤2 not constituting a safety risk based on investigators judgement is acceptable.
- The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled CNS leukemia at the discretion of the PI. (2) Use of 1-2 doses of cytarabine (up to 1.5 g/m2 each dose) for patients with rapidly proliferative disease is allowed up to 7 days before the start of study therapy (7 days washout). Use of hydroxyurea for patients with rapidly proliferative disease is allowed on study and before the start of study therapy and will not require a washout. These medications will be recorded in the case-report form.
- Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted. Patients with a known history of CNS disease must have been treated with CNS directed therapy, have at least 2 consecutive LPs with no evidence of CNS leukemia, and must be clinically stable for at least 4 weeks prior to enrollment and have no ongoing neurological symptoms that in the opinion of the treating physician are related to the CNS disease
- Serum biochemical values with the following limits:
- Patients must have adequate renal function as demonstrated by a creatinine clearance (CrCl) ≥ 40 mL/min calculated by either the Cockcroft-Gault formula, Modification of Diet in Renal Disease (MDRD) eGFR or measured by 24 hours' urine collection. For patients with BMI >23, Adjusted body weight and not Ideal Body Weight is the recommended parameter.
- Direct bilirubin <1.5 x ULN unless considered due to Gilbert's syndrome
- Aspartate aminotransferase or alanine aminotransferase ≤2.0 x ULN (aspartate aminotransferase or alanine aminotransferase ≤3.0 x ULN if deemed related to leukemia by the treating physician) 10. White blood cell count <10 x 109/L. Hydroxyurea may be used to reduce the WBC count to < 10x109/L.
- 11. Ability to understand and provide signed informed consent. 12. Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment 13. Women of childbearing potential must agree to use an adequate method of contraception during the study and until 4 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment.
Who cannot join
- Patients with any other known concurrent severe and/or uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study.
- 2. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.
- 3. Prior organ transplantation including allogenic stem-cell transplantation within 3 months prior to planned enrollment, active graft versus host disease (GVHD) >Grade 1 or requiring transplant-related immunosuppression with the exception of low dose cyclosporine and tacrolimus.
- 4. Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia.
- 5. Patients with a known HIV infection that is not well controlled (i.e. any detectable circulating viral load) at the time of enrollment.
- 6. Patients with known positive hepatitis B or C infection by serology, with the exception of those with an undetectable viral load within 3 months (Hepatitis B or C testing is not required prior to study entry). Subjects with serologic evidence of prior vaccination to HBV [i.e., HBs Ag-, and anti-HBs+] may participate.
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- 7. Patients who have had any major surgical procedure within 14 days of Day 1. 8. Other severe acute or chronic medical conditions that is active and not well controlled including colitis, inflammatory bowel disease, or psychiatric conditions including active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- 9. Active and uncontrolled disease (active infection requiring systemic therapy or fever likely secondary to infection within prior 48 hours): prophylactic antibiotics or prolonged course of IV antibiotics for controlled infection are allowed, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure NYHA class III/IV, clinically significant and uncontrolled arrhythmia, as judged by the treating physician.
- 10. Requirement to use anti-TNF drugs (infliximab, etanercept, adalimumab, certolizumab, golimumab).
- 11. Patients unwilling or unable to comply with the protocol. 12. Live vaccination within 28 days from start of therapy
Trial locations and contacts
1 site in 1 country.
About this study
To determine the feasibility of a group-based education intervention to improve adherence to recommend surveillance and risk reducing procedures, with a focus at medically underserved women and racial/ethnic minorities with BRCA 1 and 2.
Read the detailed description
Primary Objective:
To assess the feasibility benchmarks of this intervention by estimating:
- The enrollment of participants over a 3-month period.
- Attendance of participants randomized to the ACT-Together Intervention.
- Completion of baseline and follow up surveys.
Secondary Objectives:
- Increase breast cancer screening rates or intention to undergo breast cancer screening.
- Increase uptake of risk-reducing bilateral salpino-oophorectomy (rrBSO) or intention to undergo rrBSO.
- Demonstrate increase in perceived susceptibility and benefits to risk reducing interventions, and decreased barriers as measured by the Revised Champion Health Belief Scale.
Exploratory Objective:
- Participant satisfaction with the ACT-Together intervention.
- Conditions
- Cancer
- Being tested
- Education Content, Focus Group
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education ContentOther
Participants will be offered group based education sessions expected to last 90 minutes
Focus GroupOther
Participants will attend via Zoom
| Study group | Role | What they receive |
|---|---|---|
| ACT-Together Intervention | Experimental | Participants will be randomized into one of two arms through REDCap Receives: Other: Education Content |
| Standard of Care | Experimental | Participants will be randomized into one of two arms through REDCap Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start18 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Rauh-Hain, MD,MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549153
- Sponsor's protocol ID
- 2024-0236
- Other IDs
- NCI-2024-06736
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT-Together (Acting on Cancer Testing-Together)
- ClinicalTrials.gov ID
- NCT06549153
- Acronym / sponsor ID
- 2024-0236
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the feasibility of a group-based education intervention to improve adherence to recommend surveillance and risk reducing procedures, with a focus at medically underserved women and racial/ethnic minorities with BRCA 1 and 2.
Detailed description
Primary Objective:
To assess the feasibility benchmarks of this intervention by estimating:
- The enrollment of participants over a 3-month period.
- Attendance of participants randomized to the ACT-Together Intervention.
- Completion of baseline and follow up surveys.
Secondary Objectives:
- Increase breast cancer screening rates or intention to undergo breast cancer screening.
- Increase uptake of risk-reducing bilateral salpino-oophorectomy (rrBSO) or intention to undergo rrBSO.
- Demonstrate increase in perceived susceptibility and benefits to risk reducing interventions, and decreased barriers as measured by the Revised Champion Health Belief Scale.
Exploratory Objective:
- Participant satisfaction with the ACT-Together intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-Together Intervention | Experimental | Other: Education ContentParticipants will be randomized into one of two arms through REDCap |
| Standard of Care | Experimental | Other: Focus GroupParticipants will be randomized into one of two arms through REDCap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis
- Patients aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- Temporary prior measures such as apheresis, limited dose cytarabine or use of hydrea while eligibility work-up is being performed are allowed and not counted as a prior salvage
- In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks or at least 5 half-lives (whichever is shorter). The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document.
Key exclusion criteria (10 listed)
- Patients with any other known concurrent severe and/or uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study.
- 2. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.
- 3. Prior organ transplantation including allogenic stem-cell transplantation within 3 months prior to planned enrollment, active graft versus host disease (GVHD) >Grade 1 or requiring transplant-related immunosuppression with the exception of low dose cyclosporine and tacrolimus.
- 4. Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia.
- 5. Patients with a known HIV infection that is not well controlled (i.e. any detectable circulating viral load) at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education ContentParticipants will be offered group based education sessions expected to last 90 minutes | Other | ACT-Together Intervention |
| Focus GroupParticipants will attend via Zoom | Other | Standard of Care |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Rauh-Hain, MD,MPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Content and Focus Group in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.