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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMPASS (Psychoeducational / Behavioral Program) | Group Acceptance and Commitment Therapy program as part of clinical service for cancer patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | Seven group sessions |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Chesney, PhD | 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 |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Questionnaires | Other | 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. |
|
| 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 |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |