Clinical trial NCT02639208: Novel Social Media Intervention For Older Br CA Patients
Official title: Improving Support for Older Patients Receiving Neo/Adjuvant Chemotherapy for Breast Cancer Using a Novel Social Media Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Keywords: Breast Cancer I
Breast Cancer Stage II
Breast Cancer Stage III
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: CURE Foundation
First posted: 2015-12-24
Enrollment: 47
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility/ Rate of Participant Login - PLM
timeFrame: 4-6 months
Secondary outcomes:
measure: Rate of Usability of PLM
timeFrame: 6 Months
measure: Rate of Overall Satisfaction with PLM
timeFrame: 6 Months
measure: Rate of Desirability with PLM
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rachel Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.