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

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04630015
Collaborator
(none)
250
1
40
6.3

Study Details

Study Description

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 Phase
  • 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:

  3. Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer.

  4. Increasing quality of life.

  5. Reducing symptoms of depression and anxiety.

  6. Increasing physical activity.

  7. 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

Study Type:
Observational
Anticipated 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 :
Aug 31, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Margaret Chesney, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04630015
Other Study ID Numbers:
  • 20805
  • NCI-2020-08530
First Posted:
Nov 16, 2020
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022