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

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ClinicalTrials.gov Identifier: NCT04630015
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment
COVID-19 Infection Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Survey Administration

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expanded Evaluation of the Survivorship Wellness Group Program in the Context of COVID-19 and Telehealth
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Participants will complete study specific survey


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form over time [ Time Frame: Baseline, Week 9, and Week 15, up to 15 weeks total ]
    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.

  2. Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form over time [ Time Frame: Baseline, Week 9, and Week 15, up to 15 weeks total ]
    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.

  3. Changes in the Functional Assessment of Cancer Therapy (FACT-G) scores [ Time Frame: Baseline, Week 9, and Week 15, up to 15 weeks total ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in the Survivorship Wellness Group Program
Criteria

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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04630015


Contacts
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Contact: Eliza Hearst 877-827-3222 Eliza.Hearst@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Hearst Hearst    877-827-3222    Eliza.Hearst@ucsf.edu   
Contact: cancertrials@ucsf.edu         
Principal Investigator: Margaret Chesney, PhD         
Principal Investigator: Diane Shumay, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Margaret Chesney, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04630015    
Other Study ID Numbers: 20805
NCI-2020-08530 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
COVID-19
Cancer Survivorship
Additional relevant MeSH terms:
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COVID-19
Neoplasms
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases