FOCUS ON US Program for Cancer Patients

Not currently recruiting at 1 trial location

Overseen By Lelaina Senior Clinical Research Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Charles Kamen

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called FOCUS ON US to evaluate its effectiveness for cancer patients who identify as sexual or gender minorities, such as LGBTQ+ individuals, and their unpaid caregivers. The goal is to determine the program's practicality and helpfulness by comparing those who start immediately with those who wait. Participants must have been diagnosed with any invasive cancer within the last two years and have a caregiver willing to join. This trial suits individuals who can communicate in English and reside in the United States. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance support for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FOCUS ON US intervention is safe for cancer patients?

Research has shown that the FOCUS ON US program is based on the proven FOCUS program used in cancer care, utilizing methods that have been successful before. However, specific safety information for FOCUS ON US itself is not available.

The trial phase is marked as "Not Applicable," indicating that the program is likely a supportive program or therapy rather than a drug. Such programs typically carry fewer risks than drug treatments.

The FOCUS program has been used successfully in cancer care, suggesting it is generally well-received. However, without specific data, it is important to remember that each person's experience may differ. Participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FOCUS ON US program because it offers a fresh approach to supporting cancer patients. Unlike traditional treatments that mainly target the disease itself, this program focuses on enhancing the overall well-being and mental health of patients. By integrating immediate intervention and follow-up assessments, it aims to provide continuous support and improve the quality of life for those undergoing cancer treatment. This holistic approach could potentially lead to better patient outcomes and satisfaction, making it a promising addition to the current cancer care landscape.

What evidence suggests that the FOCUS ON US intervention could be effective for cancer patients?

Research has shown that the FOCUS program, which serves as the basis for the FOCUS ON US intervention, has been promising in helping cancer patients. It aims to improve crucial areas such as emotional well-being and quality of life, which can enhance treatment effectiveness. Participants in this trial will either receive the FOCUS ON US intervention immediately or join a waitlist control group. Patient stories and clinical assessments suggest that programs like this can improve the cancer treatment experience. Although specific data on FOCUS ON US is not yet available, its foundation in the well-regarded FOCUS program is encouraging. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for sexual and/or gender minority (SGM) cancer patients, such as those who identify as lesbian, gay, bisexual, transgender, queer etc., along with their informal caregivers. A total of at least 160 participants will be involved.

Inclusion Criteria

Patients must live in the United States

I am a caregiver and identify as part of the SGM community or support someone who does.

Caregivers must provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive the FOCUS On Us program immediately after baseline assessment

3 months

Multiple sessions

Follow-up

Participants are monitored for outcomes and satisfaction 3 months after completing the intervention

3 months

Waitlist Control

Participants in the waitlist control group complete a baseline assessment and receive the intervention after a 6-month follow-up

6 months

What Are the Treatments Tested in This Trial?

Interventions

• FOCUS ON US

Trial Overview The study tests the adapted FOCUS On Us program against a waitlist control in a two-arm pilot trial to see if it's feasible and acceptable for SGM cancer patients and their caregivers.

How Is the Trial Designed?

Group I: Intervention Active Control 1 Intervention

This group will complete a baseline assessment and then receive the intervention immediately. Participants will complete a post-intervention assessment survey after completing the intervention. Finally, participants will be contacted for a follow-up assessment 3 months after finishing the intervention.

Group II: Waitlist Control Active Control 1 Intervention

This group will create a baseline assessment and will not receive the intervention. Participants will complete a post-intervention assessment survey \~3 months after baseline. Following a \~6-month (from baseline) follow-up assessment, this group will be offered the intervention.

Who Is Running the Clinical Trial?

Charles Kamen

Lead Sponsor

Trials

1

Recruited

160+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01030

National Estimates of the Participation of Patients With ... The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415949/

Outcomes that matter to patients with cancer: living longer and ... Oncologists and cancer patients generally agree that the primary goals of cancer treatment are to lengthen survival and, especially in the advanced disease ...

3. cancerresearch.org cancerresearch.org/media-room/the-2024-impact-report-of-the-cancer-research-institute

The 2024 Impact Report of the Cancer Research Institute CRI's 2024 Impact Report highlights progress in cancer immunotherapy research and shares inspiring patient stories.

4. fda.gov fda.gov/media/149994/download

Core Patient-Reported Outcomes in Cancer Clinical Trials This guidance provides recommendations to sponsors for collection of a core set of patient- reported clinical outcomes (herein referred to as core patient- ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/22/7/1553/122129/Focusing-on-Core-Patient-Reported-Outcomes-in

Focusing on Core Patient-Reported Outcomes in Cancer ... Clinical outcome assessments, such as PRO, can provide important data to support the safety and efficacy of a cancer treatment. Accordingly, we should ...

6. usoncology.com usoncology.com/physicians/practice-success/patient-focus/

Patient Focus 88,000 patients enrolled in cancer clinical trials to date · Contributed to more than 100 FDA-approved cancer therapies · Hundreds of research programs enrolling ...

7. fda.gov fda.gov/about-fda/oncology-center-excellence/patient-focused-drug-development

OCE Patient-Focused Drug Development Program The PFDD Program identifies rigorous methods to assess the patient experience which complements existing survival and tumor information.

8. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/index.do

Home - National Cancer Institute The EBCCP (formerly RTIPs) website is a searchable database of evidence-based cancer control programs and is designed to provide program planners and public ...

9. globalforum.diaglobal.org globalforum.diaglobal.org/issue/june-2021/patient-focused-initiatives-in-oncology-how-the-us-government-paved-the-way/

Patient-Focused Initiatives in Oncology The intent of this online platform, called Project Patient Voice, is to make patient-reported symptom data derived from clinical trials supporting approved ...