Health TrialsbyHealthPanel

Cooperative Extension and Cancer Survivorship

ConditionCancer Survivorship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Previous adult-diagnosed cancer

Post active cancer treatment

No current active treatment, hormonal therapy permitted

Ability to get to group sessions

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: SUCCESS ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Delivery of sessions

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

Time frame
Once per week for six weeks
2

Fidelity to SUCCESS protocol

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

Time frame
Once per week for six weeks
3

Participant attendance

We will measure how many enrolled participants attend each SUCCESS session

Time frame
Once per week for six weeks
4

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)

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

Secondary outcomes

1

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).

Time frame
Baseline (week 1) and post-SUCCESS (week 7-8)
2

Physical function

We will measure physical function using the 30-second Timed Chair Rise (30sTCR), measured in seconds.

Time frame
Baseline (week 1) and post-SUCCESS (week 7-8)
3

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

Time frame
Baseline (week 1) and post-SUCCESS (week 7-8)
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Oklahoma State University

Collaborator

Source ClinicalTrials.gov
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