SUCCESS Program for Cancer Survivorship

(SUCCESS Trial)

Overseen By Ashlea C Braun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Palliative care, Hospice care, Surgical history, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults in Oklahoma who have been diagnosed with cancer, are post-active treatment (but can be on hormonal therapy), and can attend group sessions. It's designed to help improve the health outcomes of cancer survivors.

Inclusion Criteria

I have completed my cancer treatment.

I can attend group sessions.

I was diagnosed with cancer as an adult.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the SUCCESS program, which includes 6 weekly group education sessions with didactic lectures, support groups, and brief exercises

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for improvements in health-related quality of life and other psychosocial and health-related endpoints

2 weeks

Survey-based follow-up

Treatment Details

Interventions

• SUCCESS

Trial Overview The SUCCESS program aims to see if a survivorship program delivered through Cooperative Extension can boost health quality and reduce issues like financial toxicity after cancer treatment. Participants will engage in surveys and Zoom sessions over six weeks.

Participant Groups

Group I: SUCCESS Program Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Oklahoma State University

Collaborator

Trials

51

Recruited

8,600+