Cooperative Extension and Cancer Survivorship (SUCCESS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Survivorship
• Intervention / Treatment: Behavioral: SUCCESS

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashlea C Braun, PhD; Phone Number: 15672401582; Email: ashlea-braun@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • Recruiting
      • University of Oklahoma
      • Contact: Ashlea C Braun, PhD; Phone Number: 567-240-1582; Email: ashlea-braun@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet quality	We will measure diet quality as assessed via the National Cancer Institute Dietary Screener Questionnaire (DSQ). Outputs from the DSQ are intake of fruits and vegetables (cup equivalents), dairy (cup equivalents), added sugars (teaspoon equivalents), whole grains (ounce equivalents), fiber (g), and calcium (mg).	Baseline (week 1) and post-SUCCESS (week 7-8)
Physical function	We will measure physical function using the 30-second Timed Chair Rise (30sTCR), measured in seconds.	Baseline (week 1) and post-SUCCESS (week 7-8)
Depressive symptoms	Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9). This provides a numeric score from 0-27, with higher=more depression	Baseline (week 1) and post-SUCCESS (week 7-8)
Anxiety symptoms	Anxiety symptoms will be measured using the General Anxiety Disorder-7 (GAD-7). This provides a numeric score from 0-21, with higher=more anxiety.	Baseline (week 1) and post-SUCCESS (week 7-8)
Loneliness	Loneliness will be measuring using the UCLA Loneliness Scale. This provides a numeric score from 20-80, with higher=more loneliness.	Baseline (week 1) and post-SUCCESS (week 7-8)
Social isolation	Social isolation will be measured using the PROMIS Social Isolation Short Form (SF). This provides a numeric score from 4-20, with higher scores indicating more social isolation.	Baseline (week 1) and post-SUCCESS (week 7-8)
Financial Toxicity	Financial toxicity will be measured using the COST: A FACIT Measure of Financial Toxicity (FACIT-COST). The FACT-COST provides a numeric score from 0-44, with higher meaning better financial well-being.	Baseline (week 1) and post-SUCCESS (week 7-8)
Health-related quality of life	Health-related quality of life (HRQOL) will be measured using the PROMIS Global Health v1.2, which yields Global Physical Health and Global Mental Health Scores, both of which range numerically from 4-20; higher indicates better HRQOL.	Baseline (week 1) and post-SUCCESS (week 7-8)
Food insecurity	Food insecurity will be measured using the USDA 6-item food insecurity screener. This yields a numeric score from 0-6, with higher=more food insecurity,	Baseline (week 1) and post-SUCCESS (week 7-8)
Basic psychological needs	Basic psychological needs according to Self-Determination Theory (autonomy, competence, relatedness) will be measured using the Basic Psychological Need Satisfaction Scale. This provides three scores (one per psychological need) that ranges from 1-7, with higher=more of that need met.	Baseline (week 1) and post-SUCCESS (week 7-8)
Self-reported pain	Pain will be measured using the Pain, Enjoyment, and General Activity (PEG) scale which provides a numeric score from 0-10, with 10=more pain and more interference from pain.	Baseline (week 1) and post-SUCCESS (week 7-8)
Conserved Transcriptional Response to Adversity (CTRA) gene expression	Remote blood sampling procedures will be used to collect blood spots. RNA will be extracted from spots and sequenced for quantification of the 53-gene contrast score that comprises CTRA. This will only be done in a subset of participants.	Baseline (week 1) and post-SUCCESS (week 7-8)
Physical function	We will measure physical function using 5 Times Sit-to-Stand (5xSTS) tests, measured in seconds.	Baseline (week 1) and post-SUCCESS (week 7-8)
Financial Toxicity	Financial toxicity will be measured using the Composite Financial Burden Score (CFBS). The CFBS provides a numeric score from 0-6; higher scores denote increased financial burden.	Baseline (week 1) and post-SUCCESS (week 7-8)

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Oklahoma State University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 17371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No