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Recruiting NCT06869512

Cooperative Extension and Cancer Survivorship

No phase Interventional Cancer Survivorship

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SUCCESS.
Who it may be relevant to
Registry conditions: Cancer Survivorship. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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 measures

  • 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)]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Oklahoma — Tulsa

Publications

  • 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. PMID 39388009

Identifiers

NCT: NCT06869512 · 17371

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗