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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

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE December 24, 2015
Last Update Posted Date July 22, 2020
Study Start Date  ICMJE December 2015
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
Rate of Participant Login - PLM [ Time Frame: 4 Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Rate of Usability of PLM [ Time Frame: 6 Months ]
  • Rate of Overall Satisfaction with PLM [ Time Frame: 6 Months ]
  • Rate of Desirability with PLM [ Time Frame: 6 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Social Media Intervention For Older Br CA Patients
Official Title  ICMJE Improving Support for Older Patients Receiving Neo/Adjuvant Chemotherapy for Breast Cancer Using a Novel Social Media Intervention
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
Intervention  ICMJE Other: PatientsLikeMe (PLM)
Study Arms  ICMJE 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
Intervention: Other: PatientsLikeMe (PLM)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 1, 2019)
47
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2015)
100
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02639208
Other Study ID Numbers  ICMJE 15-326
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE CURE Foundation
Investigators  ICMJE
Principal Investigator: Rachel Freedman, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP