Cancer Clinical Trial
Official title:
Promoting Quality of Life Among Young Adult Cancer Survivors
Verified date | August 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study expands on a prior pilot study to refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the intervention to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two National Cancer Institute (NCI)-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). Participants will be randomly assigned (stratified by age and sex) to one of the 8-week treatment conditions in a 2:1 ratio (2 to intervention: 1 to attention control).
Status | Completed |
Enrollment | 57 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: - Aged 18 to 39, as of January 15th, 2017 - Speak English - Be within two years of cancer treatment completion (since January 15th, 2015) - Have a functioning smartphone and reliable internet access - Be willing to complete study activities Exclusion Criteria: - Cancer recurrence since treatment completion - Diagnosis of a central nervous system cancer (to ensure requisite mental/emotional functioning to engage in the program) - Diagnosis of a thyroid cancer - History of alcohol or drug dependency in the past year, or psychosis, bipolar disorder, or major depressive disorder - In hospice |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Winship Cancer Institute | Atlanta | Georgia |
United States | Markey Cancer Center | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participation rate | The participation rate will be recorded to assess feasibility of the intervention. | Baseline | |
Other | Retention rate | The retention rate will be recorded to assess feasibility of the intervention. | Month 2, Month 6 | |
Other | Use of AWAKE | Acceptability will be assessed by evaluating the number of participants in the intervention who use the AWAKE app. Participants will be asked about use of specific components of the app, such as watching the videos, recording health behaviors and mood, and completing homework. | Month 2 | |
Other | Satisfaction with AWAKE | Participants randomized to AWAKE will receive a survey to assess their satisfaction with the intervention. Participants will indicate the usefulness of the different components of the AWAKE program as well as overall satisfaction with the program. | Month 2 | |
Primary | Change in Adult Trait Hope Scale Score | The Adult Trait Hope Scale is a 12-item survey where respondents indicate how true a statement is on a scale of 1 (definitely false) to 8 (definitely true). The Hope Scale includes two subscales of four items each plus four distracter items. Higher scores on the Pathways subscale (example question: "I can think of many ways to get out of a jam") indicate higher levels of pathways thinking. Higher scores on the Agency subscale (example question: "I energetically pursue my goals") indicate higher levels of agency thinking. The subscales will be summed to obtain a total hope score. Total scores can range from 8 to 64 with higher scores indicating higher levels of hope. | Baseline, Month 2, Month 6 | |
Secondary | Change in 36-Item Short Form Health Survey (SF-36) Score | The 36-Item Short-Form Health Survey (SF-36) asks respondents to rate their health and abilities to do their usual tasks. The SF-36 uses a variety of questions and response options and includes 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health). Responses are coded on a scale of 0 to 100 where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed and averaged to obtain a mean score for the entire survey. The SF-36 is standardized to the general population with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better than average health while scores below 50 are worse than average health scores. |
Baseline, Month 2, Month 6 | |
Secondary | Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score | The FACT-G is a 27-item quality of life (QOL) measure specific to cancer patients to provide insight into cancer specific factors in four dimensions (physical, social/family, emotional, functional well-being). Participants respond to a list of statements that tend to impact people with cancer by indicating how much they are impacted on a scale of 0 (not at all) to 4 (very much). Scores for negatively worded statements are reversed so that higher scores indicate positive health. Scores from the four dimensions can be summed to create a total score. Total possible scores range from 0 to 108, with higher scores indicating increased well being. | Baseline, Month 2, Month 6 |
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