Clinical trial NCT06869512: Cooperative Extension and Cancer Survivorship
Official title: Cooperative Extension and Cancer Survivorship: Supportive Care Via Cooperative Extension Services (SUCCESS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivorship
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma State University
First posted: 2025-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Delivery of sessions
timeFrame: Once per week for six weeks
measure: Fidelity to SUCCESS protocol
timeFrame: Once per week for six weeks
measure: Participant attendance
timeFrame: Once per week for six weeks
measure: Acceptability of SUCCESS
timeFrame: Measured after SUCCESS (week 7-8 of the clinical trial)
Secondary outcomes:
measure: Diet quality
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Physical function
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Depressive symptoms
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Anxiety symptoms
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Loneliness
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Social isolation
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Financial Toxicity
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Health-related quality of life
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Food insecurity
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Basic psychological needs
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Self-reported pain
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Conserved Transcriptional Response to Adversity (CTRA) gene expression
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Physical function
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
measure: Financial Toxicity
timeFrame: Baseline (week 1) and post-SUCCESS (week 7-8)
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
References:
citation: 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.