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Completed

NCT Number: NCT04636905

Evaluation of Survivorship Wellness Group Program for Patients Treated at University of California, San Francisco (UCSF)

Interdisciplinary psychological interventions targeting survivorship are not only understudied but face several implementation challenges. For this project, the study team is proposing to analyze these data to report on preliminary pilot outcomes, as well as acceptability and feasibility of the implementation of the Survivorship Wellness Group Program, an interdisciplinary wellness and health-behavior change program for survivors of cancer, who have completed treatment at University of California, San Francisco and are currently without evidence of active disease.

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms

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

STUDY 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.
  • 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

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 University of California, San Francisco, 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

questionnaires

Other

Participants will be asked to complete a series of questionnaires assessing quality of life and other general health outcomes

Primary outcomes

  1. Change in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form Depression scores over time

    Time frame: Up to 16 weeks

    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.

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

    Time frame: Up to 16 weeks

    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.

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

    Time frame: Up to 16 weeks

    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.

  4. Frequency of participant responses to Program Satisfaction survey item

    Time frame: Week 16

    Program satisfaction is measured by the participant's response to the following item: "How satisfied were you, overall, with this program?". Responses ranged from Not at all satisfied, Somewhat satisfied, Mostly satisfied, and Extremely satisfied. Responses will be counted and reported by category.

  5. Changes in the frequency of participant responses cancer survivorship wellness survey: Importance

    Time frame: Up to 16 weeks

    The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing importance is rated by the participant in terms of how important it is to learn about topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all important", "Somewhat important", "Moderately important", "Very important", and "Extremely important".

  6. Changes in the frequency of participant responses cancer survivorship wellness survey- Knowledge

    Time frame: Up to 16 weeks

    The 16 item cancer survivorship wellness survey assesses each participant for their level of importance in learning about various wellness topics of cancer survivorship and their current knowledge of these topics. Each item addressing knowledge is rated by the participant in terms of how knowledgeable the participants are regarding topics specific to cancer survivorship. Items are rated according to 5 categories "Not at all knowledgeable", "Somewhat knowledgeable", "Moderately knowledgeable", "Very knowledgeable", and "Extremely knowledgeable".

  7. Changes in the frequency of participant responses to exercise frequency survey item

    Time frame: Up to 16 weeks

    The frequency of current exercise for participants was measured by a single item "How frequently do you exercise currently"? Responses are comprised of 5 categories: "Every day", "Several times per week", "Once per week", "Less than once per week", "Several times per month", "Once per month", and "Less than once per month"

  8. Changes in the frequency of participant responses to exercise intensity survey item

    Time frame: Up to 16 weeks

    The intensity of current exercise for participants was measured by a single item "How would you rate the intensity of your current exercise regimen?". Responses are comprised of 5 categories: "Very low intensity", "Light intensity", "Moderate intensity", and "High intensity".

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Evaluation of the Survivorship Wellness Group Program: An Interdisciplinary Goal-Setting Clinical Group Program for Survivors of Cancer at UCSF

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2020
Registry last updated
Jun 14, 2024

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.

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