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Active, Not Recruiting

NCT Number: NCT04713449

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Empowered Survivor Online

Other

Informational online intervention for head and neck cancer survivors

Springboard Beyond Cancer

Other

Informational online intervention for all cancer survivors

Survey Administration

Other

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

Primary outcomes

  1. Self-efficacy score

    Time frame: Baseline, two and 6 months post-baseline

    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.

  2. Preparedness for survivorship

    Time frame: Baseline, two and 6 months post-baseline

    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.

  3. Quality of Life score measured using the The European Organization for Research and Treatment of Cancer (EORTC)- Head and Neck

    Time frame: Baseline, two and 6 months post-baseline

    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.

Secondary outcomes

  1. Performance of oral self-exam, past month

    Time frame: Baseline, two and 6 months post-baseline

    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.

  2. Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam

    Time frame: Baseline, two and 6 months post-baseline

    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.

  3. Performance of exercises to improve swallowing, past month (yes/no)

    Time frame: Baseline, two and 6 months post-baseline

    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.

  4. Performance of head/neck exercises, past month (yes/no)

    Time frame: Baseline, two and 6 months post-baseline

    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.

Other outcomes

  1. Action and Planning Coping

    Time frame: Baseline, two and 6 months post-baseline

    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.

  2. Patient activation

    Time frame: Baseline, two and 6 months post-baseline

    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.

  3. Information Needs

    Time frame: Baseline, two and 6 months post-baseline

    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.

  4. Support needs

    Time frame: Baseline, two and 6 months post-baseline

    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.

  5. Concerns about recurrence scale

    Time frame: Baseline, two and 6 months post-baseline

    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.

  6. Moderator-Race/ethnicity

    Time frame: Baseline only

    Race/ethnicity will be assessed.

  7. Moderator-Receipt of survivorship care plan

    Time frame: Baseline only

    Yes/No did the participant receive a survivorship care plan

  8. Moderator- Baseline self-efficacy score

    Time frame: Baseline Only

    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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)
  • The Cancer Registry of Greater California
  • The New Jersey State Cancer Registry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Jan 19, 2021
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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