CancerNCT04636905
Evaluation of Survivorship Wellness Group Program for Patients Treated at University of California, San Francisco (UCSF)
An observational study of Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaires
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2020to 30 Jan 2024
- 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
- Adult, Older adult
Study population: Survivors of cancer who have been treated at University of California, San Francisco
Who may be able to join
- 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
Who cannot join
- 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
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 the Survivorship Wellness Group Program: An Interdisciplinary Goal-Setting Clinical Group Program for Survivors of Cancer at UCSF
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.
Read the detailed description
STUDY OBJECTIVES:
- 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.
- To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:
- Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer
- Increasing quality of life
- Reducing symptoms of depression and anxiety
- Increasing physical activity
- Conditions
- Cancer
- Being tested
- Questionnaires
- Keywords
- Quality of Life, Survivorship, Health Behaviors
- Medical subject headings
- Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will be asked to complete a series of questionnaires assessing quality of life and other general health outcomes
| Study group | Role | What they receive |
|---|---|---|
| Survivorship Wellness Group | Participants will be enrolled in a 15 week program to assess quality of life and general health outcomes Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form Depression 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.
Measured: Up to 16 weeks
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.
Measured: Up to 16 weeks
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 16 weeks
Frequency of participant responses to Program Satisfaction survey item
Program satisfaction is measured by the participant's response to the following item: "How satisfied were you, overall, with this program?". Responses ranged from Not at all satisfied, Somewhat satisfied, Mostly satisfied, and Extremely satisfied. Responses will be counted and reported by category.
Measured: Week 16
Changes in the frequency of participant responses cancer survivorship wellness survey: Importance
The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing importance is rated by the participant in terms of how important it is to learn about topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all important", "Somewhat important", "Moderately important", "Very important", and "Extremely important".
Measured: Up to 16 weeks
Changes in the frequency of participant responses cancer survivorship wellness survey- Knowledge
The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing knowledge is rated by the participant in terms of how knowledgeable the participants are regarding topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all knowledgeable", "Somewhat knowledgeable", "Moderately knowledgeable", "Very knowledgeable", and "Extremely knowledgeable".
Measured: Up to 16 weeks
Changes in the frequency of participant responses to exercise frequency survey item
The frequency of current exercise for participants was measured by a single item "How frequently do you exercise currently"? Responses are comprised of 5 categories: "Every day", "Several times per week", "Once per week", "Less than once per week", "Several times per month", "Once per month", and "Less than once per month"
Measured: Up to 16 weeks
Changes in the frequency of participant responses to exercise intensity survey item
The intensity of current exercise for participants was measured by a single item "How would you rate the intensity of your current exercise regimen?". Responses are comprised of 5 categories: "Very low intensity", "Light intensity", "Moderate intensity", and "High intensity".
Measured: Up to 16 weeks
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 start26 May 2020
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
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
- 53 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
- NCT04636905
- Sponsor's protocol ID
- 20802
- Status last verified
- Jun 2024
- First submitted
- 13 Nov 2020
- Last updated
- 14 Jun 2024
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Survivorship Wellness Group Program: An Interdisciplinary Goal-Setting Clinical Group Program for Survivors of Cancer at UCSF
- ClinicalTrials.gov ID
- NCT04636905
- Acronym / sponsor ID
- 20802
- Conditions
- Cancer
- Keywords
- Quality of Life, Survivorship, Health Behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (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.
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:
- 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.
- To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:
- Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer
- Increasing quality of life
- Reducing symptoms of depression and anxiety
- Increasing physical activity
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivorship Wellness Group | – | Other: QuestionnairesParticipants will be enrolled in a 15 week program to assess quality of life and general health outcomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Survivors of cancer who have been treated at University of California, San Francisco
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| QuestionnairesParticipants will be asked to complete a series of questionnaires assessing quality of life and other general health outcomes | Other | Survivorship Wellness Group |
Primary outcome
Change in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form Depression scores over time
Time frame: Up to 16 weeks
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.
Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form scores over time
Time frame: Up to 16 weeks
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.
Changes in the Functional Assessment of Cancer Therapy scale (FACT-G) scores over time
Time frame: Up to 16 weeks
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.
Frequency of participant responses to Program Satisfaction survey item
Time frame: Week 16
Program satisfaction is measured by the participant's response to the following item: "How satisfied were you, overall, with this program?". Responses ranged from Not at all satisfied, Somewhat satisfied, Mostly satisfied, and Extremely satisfied. Responses will be counted and reported by category.
Changes in the frequency of participant responses cancer survivorship wellness survey: Importance
Time frame: Up to 16 weeks
The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing importance is rated by the participant in terms of how important it is to learn about topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all important", "Somewhat important", "Moderately important", "Very important", and "Extremely important".
Changes in the frequency of participant responses cancer survivorship wellness survey- Knowledge
Time frame: Up to 16 weeks
The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing knowledge is rated by the participant in terms of how knowledgeable the participants are regarding topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all knowledgeable", "Somewhat knowledgeable", "Moderately knowledgeable", "Very knowledgeable", and "Extremely knowledgeable".
Changes in the frequency of participant responses to exercise frequency survey item
Time frame: Up to 16 weeks
The frequency of current exercise for participants was measured by a single item "How frequently do you exercise currently"? Responses are comprised of 5 categories: "Every day", "Several times per week", "Once per week", "Less than once per week", "Several times per month", "Once per month", and "Less than once per month"
Changes in the frequency of participant responses to exercise intensity survey item
Time frame: Up to 16 weeks
The intensity of current exercise for participants was measured by a single item "How would you rate the intensity of your current exercise regimen?". Responses are comprised of 5 categories: "Very low intensity", "Light intensity", "Moderate intensity", and "High intensity".
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 14 Jun 2024.
- 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 4 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 14 Jun 2024. 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?
Change in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form Depression scores over time (time frame: Up to 16 weeks). The study lists 8 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 14 Jun 2024.