CClinicalTrials.gg
CompletedNCT04636905Updated Jun 14, 2024

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

An observational study in Cancer, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
53
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Cancer

Keywords

  • Quality of Life
  • Survivorship
  • Health Behaviors
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
53 participants (actual)
Patient registry
No

Groups and cohorts

  • Survivorship Wellness Group

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

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 16 weeks

  2. 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.

    Time frame: Up to 16 weeks

  3. 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.

    Time frame: Up to 16 weeks

  4. 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.

    Time frame: Week 16

  5. 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".

    Time frame: Up to 16 weeks

  6. 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".

    Time frame: Up to 16 weeks

  7. 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"

    Time frame: Up to 16 weeks

  8. 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".

    Time frame: Up to 16 weeks

07

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94143, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04636905
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Nov 19, 2020
Start date
May 26, 2020
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
Jun 14, 2024

Study contacts

Margaret Chesney, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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