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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Questionnaires

Detailed Description

STUDY OBJECTIVES:

1. 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.

2. To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:

   1. Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer
   2. Increasing quality of life
   3. Reducing symptoms of depression and anxiety
   4. Increasing physical activity

• Study Type: Observational
• Enrollment (Actual): 53

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: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Survivorship Wellness Group; Participants will be enrolled in a 15 week program to assess quality of life and general health outcomes	Other: Questionnaires; Participants will be asked to complete a series of questionnaires assessing quality of life and other general health outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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): May 26, 2020
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Survivorship; Health Behaviors
• Other Study ID Numbers: 20802

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