Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survivor Trial
Overview
- Phase
- Not Applicable
- Intervention
- Empowered Survivor Online
- Conditions
- Oral Cancer
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 643
- Locations
- 1
- Primary Endpoint
- Self-efficacy score
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Sharon Manne, PhD
Chief, Behavioral Sciences
Rutgers, The State University of New Jersey
Eligibility Criteria
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
- Not provided
Arms & Interventions
Empowered Survivor online
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.
Intervention: Empowered Survivor Online
Empowered Survivor online
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.
Intervention: Survey Administration
Springboard Beyond Cancer
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.
Intervention: Springboard Beyond Cancer
Springboard Beyond Cancer
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.
Intervention: Survey Administration
Outcomes
Primary Outcomes
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.
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.
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
- Performance of exercises to improve swallowing, past month (yes/no)(Baseline, two and 6 months post-baseline)
- Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam(Baseline, two and 6 months post-baseline)
- Performance of head/neck exercises, past month (yes/no)(Baseline, two and 6 months post-baseline)
- Performance of oral self-exam, past month(Baseline, two and 6 months post-baseline)