Recruiting

FOCUS On Us

Sponsor:

Charles Kamen

Code:

NCT06800053

Conditions

Cancer Support

Oncology Patients

Caregivers

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

FOCUS ON US

Study Details

Brief summary:

Our aim for this study is to assess the feasibility and acceptability and explore potential outcomes of the adapted FOCUS On Us intervention in a two-arm pilot trial. The investigators will randomize 80 sexual and/or gender minority (SGM; e.g., lesbian, gay, bisexual, transgender, queer, etc.) cancer patients and their ≥80 informal caregivers (total N≥160) to either FOCUS On Us (adapted from the evidence-based FOCUS program) or a waitlist control.

Conditions

Cancer Support

Oncology Patients

Caregivers

Study ID

NCT06800053

Start date

Sep 4, 2025

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Patients must:

1. have been diagnosed or had a biochemical recurrence or progression of any invasive (e.g., Stage ≥1) cancer within the past 24 months;
2. have at least one informal (unpaid) caregiver willing to participate in the program;
3. identify as a sexual and/or gender minority (SGM) OR have a caregiver who identifies as SGM (e.g., either the patient or caregiver(s) must be SGM);
4. be age 18 or older;
5. be able to complete all written and oral components of the study in English;
6. provide informed consent;
7. live in the United States.

Caregivers must:

1. self-report having provided support for a cancer patient as an informal (unpaid) caregiver;
2. have a cancer patient for whom they provided support willing to participate in the program;
3. identify as a sexual and/or gender minority (SGM) OR have provided support to a patient who identifies as SGM (e.g., either the patient or caregiver(s) must be SGM);
4. be age 18 or older;
5. be able to complete all written and oral components of the study in English;
6. provide informed consent;
7. live in the United States

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

no intervention: Waitlist Control

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.

Interventions

FOCUS ON US

This intervention will include 5 sessions cover 5 core content areas, represented by the acronym FOCUS. Family involvement (F) Outlook and meaning (O) Coping effectiveness (C) Uncertainty reduction (U) Symptom management (S) Content from every area is presented in the 3 longer in-depth sessions and reinforced in the 2 shorter check-in sessions. FOCUS encourages participants to work as a team, communicate openly, and support one another, and uses skill building (e.g., stress reduction techniques, healthy behaviors), education (e.g., symptom trajectories, information gathering), and problem-solving therapy to address "here-and-now" issues that impact QOL. The intervention is flexible, allowing more attention to be spent on issues relevant to particular patients/caregivers.

Primary outcome measure

  • Feasibility of Intervention [ Time Frame: 3 months after randomization ]
  • Acceptability [ Time Frame: 3 months after randomization ]

Central Contacts and Locations

Central contacts

Lelaina Senior Clinical Research Specialist

607-542-9215Lelaina_nagle@urmc.rochester.edu

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Theresa Hastert

fs9450@wayne.edu

Nora Akcasu

nora.akcasu@med.wayne.edu

Principal Investigator:

Theresa Hastert

University Of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Charles Ph.D, M.P.H., Associate professor

585-275-9958Charles_Kamen@urmc.rochester.edu

Lelaina Senior Clinical Research Specialist

585-274-0475Lelaina_Nagle@urmc.rochester.edu

Principal Investigator:

Charles Ph.D, M.P.H., Associate professor

More Information

Sponsor

Charles Kamen

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Cancer Patients and Caregivers
  • LGBTQ+

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Charles Kamen on 2026-08-17.