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OpenTrials
Completed

NCT Number: NCT03770598

Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients

Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32081, United States

About this study

Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of breast cancer within last three years
  • Able to communicate in English or with the help of an interpreter.
  • Access to a device with internet connection

Exclusion criteria

  • Breast cancer patients who are considered for hospice or expected survival of less than six months.
  • Presence of active suicidal ideations.
  • Presence of active psychosis.
  • Presence of dementia

Treatment and study plan

Standard of Care Distressed in study Arm Distressed

Behavioral

Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.

Psycho-education

Behavioral

Mindfulness based stress reduction class, yoga and education material

Team Based Care

Behavioral

Psychiatrist, Oncologist, clinical social worker, study coordinator

Standard of Care Non-Distressed

Behavioral

No psycho-education about wellness promotion or health. These patients will be monitored only.

Primary outcomes

  1. Change in Wellness

    Time frame: baseline, 6 months

    Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time.

Secondary outcomes

  1. Improvement in depression compared to baseline

    Time frame: one year

    measured by using PHQ-8 (Patient Health Questionnaire); this is an 8 item scale. Scores of 5 or less are considered no depression, 5-10, mild depression, 11-15, moderate depression, 16-20 moderately severe and more than 20 is considered severe depression.

  2. Improvement in anxiety compared to baseline

    Time frame: One Year

    Will be measured by GAD-7 (Generalized Anxiety Disorder 7-item Scale). Its a 7 item scale. Cut points of 5, 10, 15 represent mild, moderate and severe levels of anxiety.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2018
Registry last updated
Apr 19, 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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