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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-08530 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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This study evaluates the effects of the Survivorship Wellness Group Program following active treatment, as well as to learn from Survivorship Wellness participants about their concerns regarding the current COVID-19 pandemic. This study may help to evaluate the impact of the survivorship program on patient well-being, provide evidence for use in grant application and publications, and ultimately inform the continued improvement of survivorship care.
PRIMARY OBJECTIVES:
To examine the feasibility and acceptability of implementing an interdisciplinary goal-setting clinical group program focused on domains of physical, psychological, and spiritual wellness for survivors of cancer at University of California San Francisco (UCSF).
To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:
To assess differences in patient wellbeing and in the impact of the Survivorship Wellness program during the period of COVID-19 and telehealth classes.
OUTLINE:
Patients complete surveys over 5-10 minutes at baseline (i.e. before participating in the program), and at 9 and 15 weeks follow up on the impact of COVID-19 on survivorship. Patients also complete a survey assessing how patients rate telehealth classes in the Survivorship Wellness program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (surveys) | Patients complete surveys over 5-10 minutes at baseline (i.e. before participating in the program), and at 9 and 15 weeks follow up on the impact of COVID-19 on survivorship. Patients also complete a survey assessing how patients rate telehealth classes in the Survivorship Wellness program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Administration | Other | Participants will complete study specific survey |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form over time | The PROMIS Anxiety Short form consists of 2 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test. | Baseline, Week 9, and Week 15, up to 15 weeks total |
| Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form over time | The PROMIS Depression Short form consists of 4 items addressing patient depression with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of depression. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test. | Baseline, Week 9, and Week 15, up to 15 weeks total |
| Changes in the Functional Assessment of Cancer Therapy (FACT-G) scores | The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life (HRQOL) in cancer patients with 4 domains of interest: Physical, social, emotional, and functional well-being. Each tem response score ranges from 0 (not at all) to 5 (very much). The total score is a sum of the subscale scores, with a range from 0 - 108. The higher the score, the better the HRQOL. | Baseline, Week 9, and Week 15, up to 15 weeks total |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled in the Survivorship Wellness Group Program
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Chesney, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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