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CompletedNCT04630015Updated May 9, 2023

Expanded Evaluation of the Survivorship Wellness Group Program in the Context of COVID-19 and Telehealth

An observational study in COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, 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 2023-05-09.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
134
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates the effects of the Survivorship Wellness Group Program following active treatment, as well as to learn from Survivorship Wellness participants about their concerns regarding the current COVID-19 pandemic. This study may help to evaluate the impact of the survivorship program on patient well-being, provide evidence for use in grant application and publications, and ultimately inform the continued improvement of survivorship care.

Read the detailed description

PRIMARY 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 (UCSF).
  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.
  3. To assess differences in patient wellbeing and in the impact of the Survivorship Wellness program during the period of COVID-19 and telehealth classes.

OUTLINE:

Patients complete surveys over 5-10 minutes at baseline (i.e. before participating in the program), and at 9 and 15 weeks follow up on the impact of COVID-19 on survivorship. Patients also complete a survey assessing how patients rate telehealth classes in the Survivorship Wellness program.

02

Conditions studied

  • COVID-19 Infection
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Keywords

  • COVID-19
  • Cancer Survivorship
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 134 is below the median of 260 across 3,188 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (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

Patients enrolled in the Survivorship Wellness Group Program

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • English-speaking
  • Treated for any kind of cancer at UCSF, 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
134 participants (actual)
Patient registry
No

Groups and cohorts

  • Observational (surveys)

    Patients complete surveys over 5-10 minutes at baseline (i.e. before participating in the program), and at 9 and 15 weeks follow up on the impact of COVID-19 on survivorship. Patients also complete a survey assessing how patients rate telehealth classes in the Survivorship Wellness program.

    Other: Survey Administration

Interventions

  • OtherSurvey Administration

    Participants will complete study specific survey

06

What researchers measure

Primary outcomes

  1. Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form 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.

    Time frame: Baseline, Week 9, and Week 15, up to 15 weeks total

  2. Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form 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.

    Time frame: Baseline, Week 9, and Week 15, up to 15 weeks total

  3. Changes in the Functional Assessment of Cancer Therapy (FACT-G) scores

    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: Baseline, Week 9, and Week 15, up to 15 weeks total

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, 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
NCT04630015
Responsible party
Sponsor
First posted
Nov 16, 2020
Start date
Aug 31, 2020
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
May 9, 2023

Study contacts

Margaret Chesney, MD
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 May 2023. You cannot join it, but the record below documents what was studied.

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