COMPASS: A Group ACT Program for Cancer Patients Treated at UCSF

Evaluation of Compass: A Group Clinical Program in Psycho-Oncology Using Acceptance and Commitment Therapy to Address Fear of Recurrence/Progression in Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Other: Questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COMPASS (Psychoeducational / Behavioral Program); Group Acceptance and Commitment Therapy program as part of clinical service for cancer patients	Behavioral: Acceptance and Commitment Therapy; Seven group sessions; Other: Questionnaires; 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 follow-up time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form scores 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.	Up to 1 year
Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form scores 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.	Up to 1 year
Changes in Acceptance and Action Questionnaire II (AAQ-II) scores over time	The AAQ-II is a 7 item questionnaire used to track how participants are doing with applying psychological flexibility skills in their daily life. Item scores range from 1 ("never true") to 7 ("always true":), and total scores are computed by adding up responses for each question. Higher total scores mean less flexibility, while lower total scores mean more flexibility.	Up to 1 year
Changes in the Functional Assessment of Cancer Therapy scale (FACT-G) scores over time	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.	Up to 1 year
Changes in the Valuing Questionnaire (VQ) scores over time	The VQ is a 10-item scale designed to measure how consistently an individual has been living with their self-determined values and is helpful when administered during a course of Acceptance and Commitment Therapy (ACT). Two subscale scores are measured: Progress and Obstruction. Progress items (Range = 0 to 30) are defined as enactment and perseverance in living consistently with one's values. Higher scores represent a closer alignment between one's internal values and one's actions. Obstruction (Range = 0 to 30) represents the extent to which various disruptions "got in the way" of valued living. Higher scores represent more interference with living consistently with one's values. Total scores are calculated by summing the raw scores and calculating percentile ranks. When used as a monitoring tool during a course of ACT, successful treatment is indicated by increasing Progress Scores and decreasing Obstruction Scores.	Up to 1 year
Changes in The Fear of Cancer Recurrence Index (FCRI) severity subscale scores over time	The nine-item FCRI evaluates the presence and severity of intrusive thoughts associated with FCR. Each item is rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time"). A higher score indicates higher levels of FCR.	Up to 1 year
Changes in the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP-12) scores over time	The FACIT-SP-12 is a 12 item questionnaire which measures a participants spiritual well-being for the past 7 days. Item responses range from 0 (not at all) to 4 (very much). The sum of the item scores are used to calculate a total FACIT-SP-12 score ranging from 0 to 48. The higher the score, the better the QOL/spiritual well-being.	Up to 1 year
Changes in Five Facet Mindfulness Questionnaire (FFMQ) scores over time	The FFMQ is a 39-item questionnaire that measures five factors which represent elements of mindfulness. The five facets are Observing, Describing, Acting with awareness, Non-judging of inner experience, and Non-reactivity to inner experience. Item scores range from 1 ("never or very rarely true") to 5 ("very often or always true":), and total scores are computed by adding up responses for the questions that fall into each facet, for a range of 8-40 per facet with the exception of the Non-react scores which range from 7-35. Higher scores on the Observe, React, and Non-react facets indicate higher levels of mindfulness and higher scores on the Act with Awareness and Non-judge items indicate less mindfulness.	Up to 1 year
Changes in Happiness Index Profile (HI/P10) scores over time	The HI/P10 is a 10-item questionnaire assessing positive affect, intention, and resiliency. Each item is scored from 0 (strongly disagree) to 10 (strongly agree). HI/P10 scores are calculated by adding the scores for each item to generate a total score out of 100.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Margaret Chesney, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Survivorship
• Other Study ID Numbers: 19805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No