CancerNCT04636346
COMPASS: A Group ACT Program for Cancer Patients Treated at UCSF
An observational study of Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Acceptance and Commitment Therapy and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to 14 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Non-English speaking
- Treated elsewhere for cancer
- Psychiatric illness that would affect the ability to participate in a group activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Acceptance and Commitment Therapy, Questionnaires
- Keywords
- Survivorship
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Seven group sessions
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COMPASS (Psychoeducational / Behavioral Program) | Group Acceptance and Commitment Therapy program as part of clinical service for cancer patients Receives: Behavioral: Acceptance and Commitment Therapy; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start24 Mar 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Chesney, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636346
- Sponsor's protocol ID
- 19805
- Status last verified
- Dec 2020
- First submitted
- 13 Nov 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04636346
- Acronym / sponsor ID
- 19805
- Conditions
- Cancer
- Keywords
- Survivorship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMPASS (Psychoeducational / Behavioral Program) | – | Behavioral: Acceptance and Commitment Therapy, Other: QuestionnairesGroup Acceptance and Commitment Therapy program as part of clinical service for cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Non-English speaking
- Treated elsewhere for cancer
- Psychiatric illness that would affect the ability to participate in a group activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapySeven group sessions | Behavioural | COMPASS (Psychoeducational / Behavioral Program) |
| QuestionnairesOutcomes 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. | Other | COMPASS (Psychoeducational / Behavioral Program) |
Primary outcome
Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form scores over time
Time frame: Up to 1 year
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.
Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form scores over time
Time frame: Up to 1 year
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.
Changes in Acceptance and Action Questionnaire II (AAQ-II) scores over time
Time frame: Up to 1 year
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.
Changes in the Functional Assessment of Cancer Therapy scale (FACT-G) scores over time
Time frame: Up to 1 year
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.
Changes in the Valuing Questionnaire (VQ) scores over time
Time frame: Up to 1 year
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.
Changes in The Fear of Cancer Recurrence Index (FCRI) severity subscale scores over time
Time frame: Up to 1 year
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.
Changes in the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP-12) scores over time
Time frame: Up to 1 year
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.
Changes in Five Facet Mindfulness Questionnaire (FFMQ) scores over time
Time frame: Up to 1 year
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.
Changes in Happiness Index Profile (HI/P10) scores over time
Time frame: Up to 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Chesney, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form scores over time (time frame: Up to 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.