Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial

Study Overview
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Brief Summary
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Project's goal is evaluate an online tool the research team created called Empowered Survivor (ES) against a free online self-management intervention developed for cancer survivors by the National Cancer Institute and the American Cancer Society called Springboard Beyond Cancer.

Detailed Description
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600 patients who have completed treatment between one and three years ago and are currently cancer-free will be recruited via the New Jersey State Cancer Registry or the Cancer Registry of Greater California and randomly assigned to ES or Springboard Beyond Cancer. Participants will complete measures at baseline, 2, and 6-months post-baseline. The investigators will also complete a process evaluation of Empowered Survivor.

Official Title
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Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survivor Trial

Conditions
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Oral Cancer, Oropharyngeal Cancer, Head and Neck Cancer

Intervention / Treatment
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* Other: Empowered Survivor Online
* Other: Springboard Beyond Cancer
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years; Diagnosed with a first primary invasive oral or oropharyngeal cancer between 1 and 3 years ago; Currently cancer free (but can have experienced a recurrence); Has internet access; Read English; Has sufficient vision to read a survey and complete an online intervention Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowered Survivor online<br>The online intervention, called Empowered Survivor (ES) is a self-management intervention for patients with head and neck cancer. The intervention contains the following modules: Introduction; Difficulty Swallowing and Muscle Strength; Oral Care; Long-term Follow-Up Care/Oral exams; Calm and Connect; and Maintaining. | Other: Empowered Survivor Online<br>* Informational online intervention for head and neck cancer survivors<br>Other: Survey Administration<br>* Survey measures administered at BL, two and 6 months post-baseline<br>|
| Active Comparator: Springboard Beyond Cancer<br>Springboard Beyond Cancer is a general resource for survivors of all cancer. It is a free self-management program for cancer survivors developed by trusted sources, the ACS and the NCI. | Other: Springboard Beyond Cancer<br>* Informational online intervention for all cancer survivors<br>Other: Survey Administration<br>* Survey measures administered at BL, two and 6 months post-baseline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy score | Change in self- efficacy measured with the Self-efficacy scale (22 items) which targets confidence in managing aspects of self-care (e.g., dry mouth, swallowing, oral self-exam, communicating with providers, emotions). Administered at multiple time points to measure effect of the intervention. Ratings range from 1 (not at all confident) to 5 (very confident). An item average will be calculated. | Baseline, two and 6 months post-baseline | 
| Preparedness for survivorship | Change in preparedness for survivorship. The Preparedness for survivorship scale (10 items) developed by the investigator assesses whether information received about survivorship was sufficient, helpful, comprehensive, and covered self-care tasks. Administered at multiple time points to measure effect of the intervention. Items are rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Higher score indicate better preparedness. | Baseline, two and 6 months post-baseline | 
| Quality of Life score measured using the The European Organization for Research and Treatment of Cancer (EORTC)- Head and Neck | Change in QOL score over time. The European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire- Head and Neck-43. The European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire- Head and Neck-43 is the updated version of the EORTC H&N 35, used in the researcher's pilot work. The EORTC QLQ-HN is the most widely-used measure of Head and Neck QOL. The investigators use the total score in analyses, but will evaluate subscales. Administered at multiple time points to measure effect of the intervention. Items are rated on 1 (not at all)-4 (very much) Likert scale and higher scores indicate worse QOL. | Baseline, two and 6 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of oral self-exam, past month | 1 item asking the participant if he/she has performed an oral self-exam, past month. Yes/No. Administered at multiple time points to measure effect of the intervention. | Baseline, two and 6 months post-baseline | 
| Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam | Change in comprehensiveness of exams over time. 11 items will list the areas to check and ask participant to indicate Yes/No if the participant checked that area during the oral self-exam. Administered at multiple time points to measure effect of the intervention. | Baseline, two and 6 months post-baseline | 
| Performance of exercises to improve swallowing, past month (yes/no) | One question asking participants if they have completed exercises to improve swallowing in the past month. Administered at multiple time points to measure effect of the intervention. | Baseline, two and 6 months post-baseline | 
| Performance of head/neck exercises, past month (yes/no) | One question asking participants if they have completed head and neck exercises in the past month. Administered at multiple time points to measure effect of the intervention. | Baseline, two and 6 months post-baseline |