Evaluation of Survivorship Wellness Group Program for Patients Treated at University of California, San Francisco (UCSF)

NCT04636905 | Completed

• 1 other identifier: 20802
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cancer

Keywords

Quality of Life; Survivorship; Health Behaviors

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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".

  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".

  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"

  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".

  Up to 16 weeks

Study Arms (1)

Survivorship Wellness Group

Participants will be enrolled in a 15 week program to assess quality of life and general health outcomes

Other: Questionnaires

Interventions

Questionnaires OTHER

Participants will be asked to complete a series of questionnaires assessing quality of life and other general health outcomes

Survivorship Wellness Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Survivors of cancer who have been treated at University of California, San Francisco

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Neoplasms; Health Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Margaret Chesney, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: May 26, 2020
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)