Clinical trial NCT04636905: Evaluation of Survivorship Wellness Group Program for Patients Treated at University of California, San Francisco (UCSF)
Official title: Evaluation of the Survivorship Wellness Group Program: An Interdisciplinary Goal-Setting Clinical Group Program for Survivors of Cancer at UCSF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Quality of Life
Survivorship
Health Behaviors
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of cancer who have been treated at University of California, San Francisco

Brief summary: Interdisciplinary psychological interventions targeting survivorship are not only understudied but face several implementation challenges. For this project, the study team is proposing to analyze these data to report on preliminary pilot outcomes, as well as acceptability and feasibility of the implementation of the Survivorship Wellness Group Program, an interdisciplinary wellness and health-behavior change program for survivors of cancer, who have completed treatment at University of California, San Francisco and are currently without evidence of active disease.

Detailed description: STUDY 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.
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

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Treated for any kind of cancer at University of California, San Francisco, 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: Change in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form Depression scores over time
timeFrame: Up to 16 weeks
measure: Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form scores over time
timeFrame: Up to 16 weeks
measure: Changes in the Functional Assessment of Cancer Therapy scale (FACT-G) scores over time
timeFrame: Up to 16 weeks
measure: Frequency of participant responses to Program Satisfaction survey item
timeFrame: Week 16
measure: Changes in the frequency of participant responses cancer survivorship wellness survey: Importance
timeFrame: Up to 16 weeks
measure: Changes in the frequency of participant responses cancer survivorship wellness survey- Knowledge
timeFrame: Up to 16 weeks
measure: Changes in the frequency of participant responses to exercise frequency survey item
timeFrame: Up to 16 weeks
measure: Changes in the frequency of participant responses to exercise intensity survey item
timeFrame: Up to 16 weeks
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, PhD
role: PRINCIPAL_INVESTIGATOR
References: