Cancer SurvivorshipSUCCESSNCT06869512
Cooperative Extension and Cancer Survivorship
A study testing SUCCESS in people with Cancer Survivorship, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship
- What is being tested?
- SUCCESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous adult-diagnosed cancer
- Post active cancer treatment
- No current active treatment, hormonal therapy permitted
- Ability to get to group sessions
- In Oklahoma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma
Tulsa, Oklahoma, 74135
Ashlea C Braun, PhD, 567-240-1582, ashlea-braun@ouhsc.edu
About this study
Official title: 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).
Read more
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
- Being tested
- SUCCESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUCCESSBehavioural
6 group-based sessions with 25 minutes of didactic content, 25 minutes of facilitated support group, and 10 minutes of group physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SUCCESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of sessions
We will measure the percent of SUCCESS sessions delivered as planned by Educators
Measured: Once per week for six weeks
Fidelity to SUCCESS protocol
We will measure what percentage of planned SUCCESS content is delivered as instructed.
Measured: Once per week for six weeks
Participant attendance
We will measure how many enrolled participants attend each SUCCESS session
Measured: 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: Measured after SUCCESS (week 7-8 of the clinical trial)
Secondary outcomes (14)
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (week 1) and post-SUCCESS (week 7-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start24 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869512
- Sponsor's protocol ID
- 17371
- Acronym
- SUCCESS
- Status last verified
- Jun 2025
- First submitted
- 7 Feb 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be made available upon request.
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.
PubMed 39388009
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Extension and Cancer Survivorship: Supportive Care Via Cooperative Extension Services (SUCCESS)
- ClinicalTrials.gov ID
- NCT06869512
- Acronym / sponsor ID
- SUCCESS / 17371
- Conditions
- Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma State University
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUCCESS Program | Experimental | Behavioral: SUCCESSThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous adult-diagnosed cancer
- Post active cancer treatment
- No current active treatment, hormonal therapy permitted
- Ability to get to group sessions
- In Oklahoma
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUCCESS6 group-based sessions with 25 minutes of didactic content, 25 minutes of facilitated support group, and 10 minutes of group physical activity | Behavioural | SUCCESS Program |
Primary outcome
Delivery of sessions
Time frame: Once per week for six weeks
We will measure the percent of SUCCESS sessions delivered as planned by Educators
Fidelity to SUCCESS protocol
Time frame: Once per week for six weeks
We will measure what percentage of planned SUCCESS content is delivered as instructed.
Participant attendance
Time frame: Once per week for six weeks
We will measure how many enrolled participants attend each SUCCESS session
Acceptability of SUCCESS
Time frame: 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)
14 secondary outcomes
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)
Physical function
Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)
Financial Toxicity
Time frame: Baseline (week 1) and post-SUCCESS (week 7-8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 39388009Pitasi 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.
- Individual participant dataSharing planned: No. Will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUCCESS in people with Cancer Survivorship, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashlea C Braun, PhD (15672401582, ashlea-braun@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of sessions (time frame: Once per week for six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.