Cooperative Extension and Cancer Survivorship

NCT06869512 | Recruiting

• 1 other identifier: 17371
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Delivery of sessions

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

  Once per week for six weeks

• Fidelity to SUCCESS protocol

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

  Once per week for six weeks

• Participant attendance

  We will measure how many enrolled participants attend each SUCCESS session

  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)

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

Secondary Outcomes (14)

• Diet quality

  Baseline (week 1) and post-SUCCESS (week 7-8)

• Physical function

  Baseline (week 1) and post-SUCCESS (week 7-8)

• Depressive symptoms

  Baseline (week 1) and post-SUCCESS (week 7-8)

• Anxiety symptoms

  Baseline (week 1) and post-SUCCESS (week 7-8)

• Loneliness

  Baseline (week 1) and post-SUCCESS (week 7-8)

Study Arms (1)

SUCCESS Program

EXPERIMENTAL

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.

Behavioral: SUCCESS

Interventions

SUCCESS BEHAVIORAL

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

SUCCESS Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma State University: collaborator

Study Sites (1)

University of Oklahoma

Tulsa, Oklahoma, 74135, United States

RECRUITING

Related Publications (1)

• 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. 2024 Oct 10. doi: 10.1007/s11764-024-01687-z. Online ahead of print.

  PMID: 39388009 BACKGROUND

Central Study Contacts

Ashlea C Braun, PhD

CONTACT

15672401582; ashlea-braun@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 11, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)