Cancer Survivorship
Conditions
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.
Interventions
BEHAVIORALSUCCESS
6 group-based sessions with 25 minutes of didactic content, 25 minutes of facilitated support group, and 10 minutes of group physical activity
Sponsors
Oklahoma State University
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Financial Toxicity | Baseline (week 1) and post-SUCCESS (week 7-8) | 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. |
| 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. |
| 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). |
| 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. |
| 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, |
| Physical function | Baseline (week 1) and post-SUCCESS (week 7-8) | We will measure physical function using the 30-second Timed Chair Rise (30sTCR), measured in seconds. |
| 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 |
| 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. |
Countries
United States
Contacts
Primary ContactAshlea C Braun, PhD
Outcome results
None listed