Clinical trial NCT04713449: Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial
Official title: Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survivor Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Oropharyngeal Cancer
Head and Neck Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The Cancer Registry of Greater California
name: The New Jersey State Cancer Registry
First posted: 2021-01-19
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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:

-

Primary outcomes:
measure: Self-efficacy score
timeFrame: Baseline, two and 6 months post-baseline
measure: Preparedness for survivorship
timeFrame: Baseline, two and 6 months post-baseline
measure: Quality of Life score measured using the The European Organization for Research and Treatment of Cancer (EORTC)- Head and Neck
timeFrame: Baseline, two and 6 months post-baseline
Secondary outcomes:
measure: Performance of oral self-exam, past month
timeFrame: Baseline, two and 6 months post-baseline
measure: Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam
timeFrame: Baseline, two and 6 months post-baseline
measure: Performance of exercises to improve swallowing, past month (yes/no)
timeFrame: Baseline, two and 6 months post-baseline
measure: Performance of head/neck exercises, past month (yes/no)
timeFrame: Baseline, two and 6 months post-baseline
Other outcomes:
measure: Action and Planning Coping
timeFrame: Baseline, two and 6 months post-baseline
measure: Patient activation
timeFrame: Baseline, two and 6 months post-baseline
measure: Information Needs
timeFrame: Baseline, two and 6 months post-baseline
measure: Support needs
timeFrame: Baseline, two and 6 months post-baseline
measure: Concerns about recurrence scale
timeFrame: Baseline, two and 6 months post-baseline
measure: Moderator-Race/ethnicity
timeFrame: Baseline only
measure: Moderator-Receipt of survivorship care plan
timeFrame: Baseline only
measure: Moderator- Baseline self-efficacy score
timeFrame: Baseline Only
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
References: