Clinical trial NCT04630015: Expanded Evaluation of the Survivorship Wellness Group Program in the Context of COVID-19 and Telehealth
Official title: Expanded Evaluation of the Survivorship Wellness Group Program in the Context of COVID-19 and Telehealth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Keywords: COVID-19
Cancer Survivorship
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in the Survivorship Wellness Group Program

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

1. 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).
2. To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:

   1. Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer.
   2. Increasing quality of life.
   3. Reducing symptoms of depression and anxiety.
   4. Increasing physical activity.
3. 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.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Treated for any kind of cancer at UCSF, though finished with active treatments (defined as chemotherapy, radiation, or surgery) at time of enrollment, and without evidence of current active cancer
* Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

Exclusion Criteria:

* Non-English speaking
* Primary cancer treatment outside of UCSF
* Currently receiving non-maintenance therapies (chemotherapy or radiation) for active cancer
* Psychiatric illness that would affect the ability to participate in a group activity

Primary outcomes:
measure: Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form over time
timeFrame: Baseline, Week 9, and Week 15, up to 15 weeks total
measure: Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form over time
timeFrame: Baseline, Week 9, and Week 15, up to 15 weeks total
measure: Changes in the Functional Assessment of Cancer Therapy (FACT-G) scores
timeFrame: Baseline, Week 9, and Week 15, up to 15 weeks total
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Margaret Chesney, MD
role: PRINCIPAL_INVESTIGATOR
References: