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RecruitingInterventional

Cooperative Extension and Cancer Survivorship: Supportive Care Via Cooperative Extension Services (SUCCESS)

NCT ID: NCT06869512Sponsor: University of OklahomaLast updated: 2025-06-26

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.

Arms & interventions

  • BehavioralSUCCESS

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

Outcome measures

Primary

  • Delivery of sessions

    We will measure the percent of SUCCESS sessions delivered as planned by Educators

    Time frame: Once per week for six weeks

  • Fidelity to SUCCESS protocol

    We will measure what percentage of planned SUCCESS content is delivered as instructed.

    Time frame: Once per week for six weeks

  • Participant attendance

    We will measure how many enrolled participants attend each SUCCESS session

    Time frame: Once per week for six weeks

  • Acceptability of SUCCESS

    We will administer a feasibility survey after SUCCESS for participants to rate how much they liked it. Rating will be on a 5-point Likert Scale ("How would you rate this program?" 1=poor, 5=excellent)

    Time frame: Measured after SUCCESS (week 7-8 of the clinical trial)

Secondary

  • Diet quality

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Physical function

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Depressive symptoms

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Anxiety symptoms

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Loneliness

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Social isolation

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Financial Toxicity

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Health-related quality of life

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Food insecurity

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Basic psychological needs

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Self-reported pain

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Conserved Transcriptional Response to Adversity (CTRA) gene expression

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Physical function

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

  • Financial Toxicity

    Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

University of Oklahoma

Tulsa, Oklahoma, 74135

Recruiting
Ashlea C Braun, PhD · Contact

References

  • Pitasi O, Hildebrand D, Liebe R, Joyce J, Nagykaldi Z, Robertson MC, Braun A. Hiding in plain sight: Cooperative Extension as an underutilized approach to improving cancer survivorship outcomes in underserved populations. J Cancer Surviv. 2026 Apr;20(2):792-803. doi: 10.1007/s11764-024-01687-z. Epub 2024 Oct 10.(PubMed)