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Completed

NCT Number: NCT05700396

Breast Cancer Survivor Educational Intervention

The goal of this study is to test a 6-week virtual education program among Black breast cancer survivors. The virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections.

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

This six-week feasibility study will evaluate a virtual support and education program among up to 15 Black female breast cancer survivors. Participants will be asked to attend a 90 minute group session once a week for 6 weeks and complete surveys pre and post intervention surveys to ascertain study endpoints. This study is supported by funding from Pfizer and in-kind support from the American Cancer Society, Inc.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • Self-identified Black or African American race
  • Age 22-79
  • Diagnosis of Stage I, II, or III invasive breast cancer
  • Completed active treatment at least 6 months ago, but within the past five years
  • Speaks English

Exclusion criteria

  • Undergoing active treatment (i.e., surgery, chemotherapy, radiation)
  • Undergoing evaluation for suspected recurrence

Treatment and study plan

Breast Cancer Survivor Education Program

Behavioral

Weekly sessions via Zoom platform with study staff.

Primary outcomes

  1. Recruitment Retention Rate

    Time frame: 6 weeks

    Defined as the number of recruited participants who initiate intervention program.

  2. Time Required to Recruit to Target

    Time frame: 6 weeks

    Defined as the amount of time to target accrual goal.

  3. Proportion of Eligible Participants

    Time frame: 6 weeks

    Defined as the number of eligible participants required to recruit required sample size.

  4. Rate of Intervention Completion

    Time frame: 6 weeks

    Defined as the number of participants who attend at least 5 of 6 sessions.

  5. Success Rate of Educational Intervention

    Time frame: 6 weeks

    Proportion of participants "very satisfied" or "completely satisfied" with intervention. Defined successful if true of 80% of participants.

  6. Data collection feasibility

    Time frame: 6 weeks

    Proportion of participants completing evaluation surveys each at baseline and week 6.

Secondary outcomes

  1. Self-Efficacy for symptom self-management

    Time frame: 6 weeks

    Self-Efficacy for symptom self-management will be assessed using Symptom-Management Self-Efficacy Scale-Breast Cancer

  2. Intention to Receive post-treatment Surveillance Mammography

    Time frame: 6 weeks

    Intention to Receive post-treatment Surveillance Mammography will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey

  3. Physical Activity Goal Change

    Time frame: 6 weeks

    Physical Activity Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey

  4. Dietary Behavior Goal Change

    Time frame: 6 weeks

    Dietary Behavior Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey

  5. Unmet information Needs

    Time frame: 6 weeks

    Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Cancer Society, Inc.
  • Pfizer

Registry information

Official study title

Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Apr 1, 2025

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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