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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04713449
• Other study ID #: 132004
• Secondary ID: Pro2020000768
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Sharon Manne, PhD
• Phone: 732-235-6759
• Email: Sharon.Manne[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Head and Neck Cancer
• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Other:
• Empowered Survivor Online
Informational online intervention for head and neck cancer survivors
• Springboard Beyond Cancer
Informational online intervention for all cancer survivors
• Survey Administration
Survey measures administered at BL, two and 6 months post-baseline

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), The Cancer Registry of Greater California, The New Jersey State Cancer Registry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Moderator-Race/ethnicity	Race/ethnicity will be assessed.	Baseline only
Other	Moderator-Receipt of survivorship care plan	Yes/No did the participant receive a survivorship care plan	Baseline only
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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