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Novel Social Media Intervention For Older Br CA Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639208
Recruitment Status : Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
CURE Foundation
Information provided by (Responsible Party):
Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Other: PatientsLikeMe (PLM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Support for Older Patients Receiving Neo/Adjuvant Chemotherapy for Breast Cancer Using a Novel Social Media Intervention
Study Start Date : December 2015
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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
Other: PatientsLikeMe (PLM)



Primary Outcome Measures :
  1. Feasibility/ Rate of Participant Login - PLM [ Time Frame: 4-6 months ]
    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


Secondary Outcome Measures :
  1. Rate of Usability of PLM [ Time Frame: 6 Months ]
    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

  2. Rate of Overall Satisfaction with PLM [ Time Frame: 6 Months ]
    Satisfaction with the PLM experience wil be assessed using a 'patient experience' survey at the end of the study

  3. Rate of Desirability with PLM [ Time Frame: 6 Months ]
    Desirability (how much they enjoyed using PLM, etc) wil be assessed using a patient experience survey at the end of the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639208


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
CURE Foundation
Investigators
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Principal Investigator: Rachel Freedman, MD Dana-Farber Cancer Institute
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Responsible Party: Rachel Freedman, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02639208    
Other Study ID Numbers: 15-326
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute:
Breast Cancer I
Breast Cancer Stage II
Breast Cancer Stage III
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases