Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Head and Neck Neoplasms

Mouth Neoplasms

Oropharyngeal Neoplasms

Lip Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

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.

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.

Informational online intervention for head and neck cancer survivors

Empowered Survivor Online

Informational online intervention for all cancer survivors

Springboard Beyond Cancer

Survey measures administered at BL, two and 6 months post-baseline

Survey Administration

Sharon Manne, PhD

Sharon L Manne, PhD

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.

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

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

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.

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.

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.

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.

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.

Yes/No did the participant receive a survivorship care plan

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

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.

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.

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial	NCT04713449	Oral Cancer Oropharyngeal C... Head and Neck C...	Empowered Survi... Springboard Bey... Survey Administ...	18 Years - 89 Years	Rutgers, The State University of New Jersey
Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial	NCT04713449	Oral Cancer Oropharyngeal C... Head and Neck C...	Empowered Survi... Springboard Bey... Survey Administ...	18 Years - 89 Years	Rutgers, The State University of New Jersey

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