INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy

Dana-Farber Cancer Institute

Status: Completed

Conditions: Breast Cancer; Breast Cancer Female; Breast Carcinoma

Treatments: Behavioral: Endocrine Therapy Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06246084

23-607

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 76 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Group A: Endocrine Therapy Education Intervention

Experimental group

Description:

Participants will complete: * Baseline visit. * Educational video once a week for 6 weeks. * 6-week survey. * 3-month survey.

Treatment:

Behavioral: Endocrine Therapy Education Program

Group B: Wait-List Control Group

No Intervention group

Description:

Participants will complete: * Baseline visit. * 6-week survey. * 3-month survey. * Access to intervention educational videos. * 2-week post video survey.