Novel Social Media Intervention For Older Br CA Patients

Breast Cancer Stage II Clinical Trial

Official title:

Improving Support for Older Patients Receiving Neo/Adjuvant Chemotherapy for Breast Cancer Using a Novel Social Media Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639208
• Other study ID #: 15-326
• Status: Completed
• Phase: N/A
• Start date: February 8, 2016
• Est. completion date: August 6, 2021

Study information

• Verified date: August 2021
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The number of patients 60 and older with breast cancer is increasing as our population ages. Despite the fact that the majority of breast cancers occur in patients 60 and over, these patients are consistently under-represented in clinical trials. Because patients 60 and older are an under-studied group, investigators do not have detailed information on the side effects and experiences for these patients receiving chemotherapy. Understanding the side effects patients receiving chemotherapy experience is an important part of this study.

In addition, past research has shown that having poor social support can affect quality of life, mood, and outcomes for people with cancer. However, few studies in the past have focused on improving the quality of life and support systems that patients have while they receive treatment.

This research study is evaluating how engaging in an online support community may improve the experience of older patients receiving chemotherapy.

Description:

This clinical trial will evaluate how an on-line health information sharing community of patients called PatientsLikeMe, www.patientslikeme.com, [or "PLM"] may help patients feel better supported during treatment. This study will also evaluate how much PLM can help collect information on side effects from chemotherapy and endocrine treatments, and radiation therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 6, 2021
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Participants must be women =60 years age with histologically or cytologically confirmed, stage I-III breast cancer with a treatment plan that includes any neoadjuvant or adjuvant chemotherapy(either in the context of standard treatment or a clinical trial and including chemotherapy, treatments targeting the human epidermal growth factor receptor protein 2 [HER2]), hormonal therapy or radiation.

• Enrollment must occur according to one of the following: (1) For those receiving chemotherapy/infusional therapy, patients must enroll during the 4 weeks prior to or on the day of treatment initiation, (2) For those enrolling during hormonal therapy and/or radiation, patients must enroll within 6 months of diagnosis of breast cancer, defined as the date of initial biopsy. Patient may be receiving hormonal therapy, radiation therapy, or both at the same time of enrollment, (3) Patients who did not enroll during their chemotherapy are still eligible to enroll during subsequent hormonal therapy or radiation as long as it is within 6 months of diagnosis.

• Participants must be approached before start of treatment. Patients must be able to understand, read, and write in English and be able to understand and have willingness to sign a written informed consent document.

• Patients are eligible regardless of ECOG performance status, life expectancy or, organ/marrow function.

• Patients must have the ability to access the internet at least once per week, and this can occur in the patient's home, relatives' homes, work setting, or Dana-Farber (in addition to coffee shops, libraries, etc if applicable). Having a computer is not required. An iPad will be provided to any patient who needs one for the duration of the study.

Exclusion Criteria:

• Patients with metastatic breast cancer are not eligible to participate.

• Participants who have started their treatment plan are not eligible.

• Those unable to understand, read, or write in English are not eligible.

• Men are not eligible for this study.

Related Conditions & MeSH terms

• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms

Intervention

Other:
• PatientsLikeMe (PLM)

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	CURE Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility/ Rate of Participant Login - PLM	We will describe the degree of patient use of the PLM platforms and the associations of short and longer term PLM use with patient characteristics	4-6 months
Secondary	Rate of Usability of PLM	Usability (how useful they found PLM, what parts of the site they used, etc.) will be assessed using a patient experience survey at the end of the study	6 Months
Secondary	Rate of Overall Satisfaction with PLM	Satisfaction with the PLM experience wil be assessed using a 'patient experience' survey at the end of the study	6 Months
Secondary	Rate of Desirability with PLM	Desirability (how much they enjoyed using PLM, etc) wil be assessed using a patient experience survey at the end of the study	6 Months