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OpenTrials
Completed

NCT Number: NCT06246084

INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy

This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy.

The name of the intervention used in this research study is:

Endocrine Therapy Education Program (a brief, video-based intervention)

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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

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.

Participation in this research study is expected to last 3 months.

It is expected that about 60 people will take part in this research study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Biologically female
  • About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
  • 18 years of age or older
  • English fluency for reading and writing.
  • Computer literacy (ability to watch videos and fill out questionnaires online)

Exclusion criteria

  • Adults unable to consent
  • Individuals with metastatic cancer
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Treatment and study plan

Endocrine Therapy Education Program

Behavioral

Brief, video-based intervention program to improve endocrine therapy adherence and experiences and to provide detailed education to participants. The intervention is distributed and assessed via the MyEmma platform, a HIPAA-compliant, online communications platform.

Primary outcomes

  1. Engagement Rate of Intervention

    Time frame: 6 weeks

    Adequate engagement of the intervention is defined as a click-to-open rate of 60% or over for the intervention group.

  2. Intervention Satisfaction Questionnaire Mean Score Group A

    Time frame: At 6 weeks

    Responses will be analyzed to determine a mean score for each item for the intervention group. The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.

  3. Intervention Satisfaction Questionnaire Mean Score Group B

    Time frame: At 14 weeks

    Responses will be analyzed to determine a mean score for each item for the control group (following the release of the intervention educational videos). The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Jan 22, 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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