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CompletedNCT02639208Updated Aug 20, 2021

Novel Social Media Intervention For Older Br CA Patients

An interventional study of PatientsLikeMe (PLM) in Breast Cancer Stage I, Breast Cancer Stage II and Breast Cancer Stage III, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-08-20.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
60 Years and older
Sex
Female
01

Study 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.

Read the 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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Conditions studied

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

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Keywords

  • Breast Cancer I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 47 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • 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)

Interventions

  • OtherPatientsLikeMe (PLM)
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 4-6 months

Secondary outcomes

  1. 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

    Time frame: 6 Months

  2. 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

    Time frame: 6 Months

  3. 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

    Time frame: 6 Months

07

Study locations

1 site
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • 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. PubMed 34275766 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02639208
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
CURE Foundation
Responsible party
Rachel Freedman, MD, MPH (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Dec 24, 2015
Start date
Feb 8, 2016
Primary completion
May 2019
Completion
Aug 6, 2021
Last update
Aug 20, 2021

Study contacts

Rachel Freedman, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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