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| ID | Type | Description | Link |
|---|---|---|---|
| Pro2020000768 | Other Identifier | Rutgers Cancer Institute of New Jersey |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Cancer Registry of Greater California | UNKNOWN |
| The New Jersey State Cancer Registry | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowered Survivor online | Experimental | 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. |
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| Springboard Beyond Cancer | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowered Survivor Online | Other | Informational online intervention for head and neck cancer survivors |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Action and Planning Coping | Change in Action and Planning coping score. The scale (8 items) assesses the degree to which a detailed plan is made for self-care tasks. Administered at multiple time points to measure effect of the intervention. Items are rated on a 5-point Likert scale(1 = strongly disagree, 5 = strongly agree). Mean scale score will be reported. Higher score = higher action coping. | Baseline, two and 6 months post-baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36662561 | Derived | Manne SL, Imanguli M, Kashy D, Pesanelli M, Frederick S, Van Cleave JH, Paddock L, Hudson S, Steinberg M, Clifford P, Domider M, Singh N. Enhancing Self-care Among Oral Cancer Survivors: Protocol for the Empowered Survivor Trial. JMIR Res Protoc. 2023 Jan 20;12:e39996. doi: 10.2196/39996. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 9, 2024 | Dec 16, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Springboard Beyond Cancer | Other | Informational online intervention for all cancer survivors |
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| Survey Administration | Other | Survey measures administered at BL, two and 6 months post-baseline |
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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 |
| Patient activation | Change in Patient activation scale score. Patient Activation Scale (13 items) assesses the active role in cancer care. Administered at multiple time points to measure effect of the intervention. Items are rated on a 4-point scale (1 = Disagree strongly, 4 = Agree strongly). Higher score = higher activation. | Baseline, two and 6 months post-baseline |
| Information Needs | Change in score over time. Information needs (23 items) is adapted from the FOCUS Health-Related Topics measure. Administered at multiple time points to measure effect of the intervention. Participants reported if they would like more information on each topic (yes/no). The number of " yes" responses are averaged. | Baseline, two and 6 months post-baseline |
| Support needs | Change in Support needs. The support needs scale (34 items) assesses physical, psychological, and health care needs. Administered at multiple time points to measure effect of the intervention. Participants are asked to indicate the extent to which they needed help in the past month (1 = No Need; Not applicable, "This is not a problem",2 = No need; Satisfied, "I did need help but my need was satisfied," 3 = Low need; "It caused me concern and I had little need for additional help," 4 = Moderate need-"It caused me concern and I had some need for additional help," 5 = High need; -"It caused me concern and I had a strong need for additional help"). Support needs that are rated as "moderate"(4) or "high" need (5) will be summed, with a range of 0 to 34. | Baseline, two and 6 months post-baseline |
| Concerns about recurrence scale | Change in concerns about recurrence. The first 4 items from the concerns about recurrence scale are measured on a 1-6 scale. with lower scores indicating less concerns or worry. The additional 21 items are rated on 0 (not at all) to 4 (extremely) with higher scores indicating more concerns or worry. Administered at multiple time points to measure effect of the intervention. | Baseline, two and 6 months post-baseline |
| Moderator-Race/ethnicity | Race/ethnicity will be assessed. | Baseline only |
| Moderator-Receipt of survivorship care plan | Yes/No did the participant receive a survivorship care plan | Baseline only |
| Moderator- Baseline self-efficacy score | The baseline score on the scale will be (22 items) examined. The scale targets confidence in managing aspects of self-care (e.g., dry mouth, swallowing, oral self-exam, communicating with providers, emotions). Ratings are 1- 5 | Baseline Only |
| D010610 |
| Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |