Recruiting

SUCCESS

Sponsor:

University of Oklahoma

Code:

NCT06869512

Conditions

Cancer Survivorship

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SUCCESS

Study Details

Brief summary:

The goal of this clinical trial is to learn if a cancer survivor program, delivered via Cooperative Extension, is feasible and if it can improve health outcomes in cancer survivors who are post-active treatment.

Aim 1: Evaluate the feasibility and acceptability of SUCCESS. Hypothesis 1: SUCCESS will be feasible and acceptable as evidenced by delivery of the intervention among Educators (implementation), including in agreement with the curriculum in Phase 1 (fidelity) with >85% attendance (demand) among participants with >80% rating the intervention as acceptable or highly acceptable on 5-point Likert-type scale (acceptability).

Aim 2: Determine the preliminary efficacy of SUCCESS for improving HRQOL (primary outcome) and other psychosocial and health-related endpoints (e.g., financial toxicity) (secondary outcomes). Hypothesis 2: Compared to matched controls, adults LWBC who complete SUCCESS will have significant improvements in HRQOL per the PROMIS Global Health v1.2 at follow-up (i.e., after 6 weeks).

Aim 3: Examine changes in conserved transcriptional response to adversity (CTRA) gene expression in a subset of interventions participants at follow-up. Hypothesis 3: Adults LWBC who complete SUCCESS will experience significant CTRA down-regulation.

This is a single arm trial and there is no comparison group.

Participants will be asked to do survey- and Zoom-based data collection before and after completing the 6-week program.

Conditions

Cancer Survivorship

Study ID

NCT06869512

Start date

Feb 24, 2025

Status verified date

Jun, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Previous adult-diagnosed cancer
  • Post active cancer treatment
  • No current active treatment, hormonal therapy permitted
  • Ability to get to group sessions
  • In Oklahoma

Exclusion Criteria:

  • Current palliative or hospice care
  • Surgical or medical history that precludes participation
  • Positive screen on the Physical Activity Readiness Questionnaire+ (PAR-Q+) without a doctor's note approving study participation

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: SUCCESS Program

This includes our cancer survivorship program which entails 6 weekly group education sessions. Each session includes 25 minutes of didactic and discussion-based lecture, 25 minutes of facilitated support group, and 10 minutes of brief group-based exercise.

Interventions

SUCCESS

6 group-based sessions with 25 minutes of didactic content, 25 minutes of facilitated support group, and 10 minutes of group physical activity

Primary outcome measure

  • Delivery of sessions [ Time Frame: Once per week for six weeks ]
  • Fidelity to SUCCESS protocol [ Time Frame: Once per week for six weeks ]
  • Participant attendance [ Time Frame: Once per week for six weeks ]
  • Acceptability of SUCCESS [ Time Frame: Measured after SUCCESS (week 7-8 of the clinical trial) ]

Central Contacts and Locations

Central contacts

Ashlea C Braun, PhD

15672401582ashlea-braun@ouhsc.edu

Locations

University of Oklahoma

Recruiting

Tulsa, Oklahoma, United States, 74135

Contacts

Ashlea C Braun, PhD

567-240-1582ashlea-braun@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Jun 26, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2025-06-26.