Clinical trial NCT04636346: COMPASS: A Group ACT Program for Cancer Patients Treated at UCSF
Official title: Evaluation of Compass: A Group Clinical Program in Psycho-Oncology Using Acceptance and Commitment Therapy to Address Fear of Recurrence/Progression in Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Survivorship
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population studied will include the participants of the COMPASS Program offered by the Cancer Center Psychosocial services (Psycho-Oncology) that consented to having their responses for the surveys to be used for research purposes. The participants of COMPASS were adult cancer patients across different cancer types. Participants that had previously consented to having their responses to the surveys kept for research purposes will have their responses accessed and kept as a part of a de-identified data set. No direct subject contact will be included

Brief summary: Cancer Center Psychosocial services (Psycho-Oncology) offers group psychoeducational and behavioral programs as part of its clinical service for cancer patients and services at the Helen Diller Family Comprehensive Cancer Center. Clinical outcomes and acceptability/feasibility and implementation process data from these programs are routinely gathered in an effort to engage in continuous quality improvement for the department.

Detailed description: For this project, the study team is proposing to retrospectively analyze a de-identified data set of these data to report on pilot data on preliminary outcomes, acceptability and feasibility of the implementation of the COMPASS: Acting Mindfully for a Valued Life, based upon Acceptance and Commitment Therapy, an evidence-based behavioral intervention and facilitated by a licensed clinical psychologist in our department. This intervention was implemented as a series of clinical offerings for seven 7-session groups between September 2015 and October 2018 for 113 individual cancer patients and survivors. Outcomes measured include anxiety, depression, fear of recurrence, psychological flexibility, mindfulness; values based living, and quality of life. Participants completed surveys at 4 time points, pre and post, and two followup time points. Measures of demographics, satisfaction and feasibility/acceptability were also collected. Insights gathered from this study will be used to inform articles, grant applications and conference presentations on the implementation of behavioral interventions for cancer patients and survivors.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Treated for any kind of cancer at University of California, San Francisco
* Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

Exclusion Criteria:

* Non-English speaking
* Treated elsewhere for 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 scores over time
timeFrame: Up to 1 year
measure: Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form scores over time
timeFrame: Up to 1 year
measure: Changes in Acceptance and Action Questionnaire II (AAQ-II) scores over time
timeFrame: Up to 1 year
measure: Changes in the Functional Assessment of Cancer Therapy scale (FACT-G) scores over time
timeFrame: Up to 1 year
measure: Changes in the Valuing Questionnaire (VQ) scores over time
timeFrame: Up to 1 year
measure: Changes in The Fear of Cancer Recurrence Index (FCRI) severity subscale scores over time
timeFrame: Up to 1 year
measure: Changes in the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP-12) scores over time
timeFrame: Up to 1 year
measure: Changes in Five Facet Mindfulness Questionnaire (FFMQ) scores over time
timeFrame: Up to 1 year
measure: Changes in Happiness Index Profile (HI/P10) scores over time
timeFrame: Up to 1 year
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: