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Novel Social Media Intervention For Older Br CA Patients

Primary Purpose

Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PatientsLikeMe (PLM)

About this trial

This is an interventional supportive care trial for Breast Cancer Stage I focused on measuring Breast Cancer I, Breast Cancer Stage II, Breast Cancer Stage III

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PatientsLikeMe (PLM)

Arm Description

After the screening procedures confirm eligibility. Baseline Survey Assessment and PatientsLikeMe Introduction Treatment Evaluation on PLM website at predetermined times per protocol Final Survey

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT02639208

First Posted

December 21, 2015

Last Updated

August 18, 2021

Sponsor

Dana-Farber Cancer Institute

Collaborators

CURE Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02639208

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

February 8, 2016 (Actual)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

CURE Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

Keywords

Breast Cancer I, Breast Cancer Stage II, Breast Cancer Stage III

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PatientsLikeMe (PLM)

Arm Type

Experimental

Arm Description

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 Type

Other

Intervention Name(s)

PatientsLikeMe (PLM)

Primary Outcome Measure Information:

Title

Feasibility/ Rate of Participant Login - PLM

Description

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 Outcome Measure Information:

Title

Rate of Usability of PLM

Description

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

Title

Rate of Overall Satisfaction with PLM

Description

Satisfaction with the PLM experience wil be assessed using a 'patient experience' survey at the end of the study

Time Frame

6 Months

Title

Rate of Desirability with PLM

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel Freedman, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34275766

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.

Results Reference

derived

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Novel Social Media Intervention For Older Br CA Patients

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