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

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.

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Key information

Conditions

COVID-19 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Infections Lung Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

PRIMARY OBJECTIVES:

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).
To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:

Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer.
Increasing quality of life.
Reducing symptoms of depression and anxiety.
Increasing physical activity.
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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Participants will complete study specific survey

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Nov 16, 2020
Registry last updated: May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed