Cooperative Extension and Cancer Survivorship

Not Applicable

Not yet recruiting

• Conditions: Cancer Survivorship

• Registration Number: NCT06869512
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Study Start: 2025-05
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Delivery of sessions	Once per week for six weeks	We will measure the percent of SUCCESS sessions delivered as planned by Educators
Fidelity to SUCCESS protocol	Once per week for six weeks	We will measure what percentage of planned SUCCESS content is delivered as instructed.
Participant attendance	Once per week for six weeks	We will measure how many enrolled participants attend each SUCCESS session
Acceptability of SUCCESS	Measured after SUCCESS (week 7-8 of the clinical trial)	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)

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	Baseline (week 1) and post-SUCCESS (week 7-8)	Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9). This provides a numeric score from 0-27, with higher=more depression
Financial Toxicity	Baseline (week 1) and post-SUCCESS (week 7-8)	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.
Diet quality	Baseline (week 1) and post-SUCCESS (week 7-8)	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).
Physical function	Baseline (week 1) and post-SUCCESS (week 7-8)	We will measure physical function using 5 Times Sit-to-Stand (5xSTS) tests, measured in seconds.
Anxiety symptoms	Baseline (week 1) and post-SUCCESS (week 7-8)	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.
Loneliness	Baseline (week 1) and post-SUCCESS (week 7-8)	Loneliness will be measuring using the UCLA Loneliness Scale. This provides a numeric score from 20-80, with higher=more loneliness.
Social isolation	Baseline (week 1) and post-SUCCESS (week 7-8)	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.
Health-related quality of life	Baseline (week 1) and post-SUCCESS (week 7-8)	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.
Food insecurity	Baseline (week 1) and post-SUCCESS (week 7-8)	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,
Basic psychological needs	Baseline (week 1) and post-SUCCESS (week 7-8)	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.
Self-reported pain	Baseline (week 1) and post-SUCCESS (week 7-8)	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.
Conserved Transcriptional Response to Adversity (CTRA) gene expression	Baseline (week 1) and post-SUCCESS (week 7-8)	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.