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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630015
• Other study ID #: 20805
• Secondary ID: NCI-2020-08530
• Status: Completed
• Start date: August 31, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Survey Administration
Participants will complete study specific survey

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 9, and Week 15, up to 15 weeks total
Primary	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.	Baseline, Week 9, and Week 15, up to 15 weeks total
Primary	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.	Baseline, Week 9, and Week 15, up to 15 weeks total