Novel Social Media Intervention For Older Br CA Patients

NCT ID: NCT02639208

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-08
• Study Completion Date: 2021-08-06

Brief 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.

Detailed 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.

Conditions

Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PatientsLikeMe (PLM)

After the screening procedures confirm eligibility.

• Baseline Survey Assessment and PatientsLikeMe Introduction
• Treatment Evaluation on PLM website at predetermined times per protocol
• Final Survey

Group Type: EXPERIMENTAL

PatientsLikeMe (PLM)

Intervention Type: OTHER

Interventions

PatientsLikeMe (PLM)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CURE Foundation

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Rachel Freedman, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Occhiogrosso RH, Ren S, Tayob N, Li T, Gagnon HC, Paz A, Freedman RA. Feasibility of an Online Patient Community to Support Older Women With Newly Diagnosed Breast Cancer. Clin Breast Cancer. 2022 Feb;22(2):178-185. doi: 10.1016/j.clbc.2021.06.004. Epub 2021 Jun 12.

Reference Type: DERIVED

PMID: 34275766 (View on PubMed)

Other Identifiers

15-326

Identifier Type: -

Identifier Source: org_study_id