Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    12000
  • sponsor
    Dana-Farber Cancer Institute
Updated on 13 November 2021

Summary

In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery.

  • It is expected that about 12,000 people will take part in this research study, 11,550 of these patients, the vast majority, will be included only for medical record review.

Description

The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery.

This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants.

  • This study will involve medical record review of 11,550 people age 65 or older with advanced cancer.

We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct a survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences.

During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 11,550 subjects for the primary outcome at 36 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.

Details
Condition Other Cancer, other malignancy, cancer other
Treatment Clinician Communication Skills Training, Advance Care Planning (ACP) Decisions Videos Decisions Aids, Video Declarations (ViDec)
Clinical Study IdentifierNCT03609177
SponsorDana-Farber Cancer Institute
Last Modified on13 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinic eligibility criteria include
More than one oncologist
Serve a patient population that is at least 30% aged 65 or older
Disease-based oncology clinic
Subject Eligibility: (for the in-person surveys)
Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity

Exclusion Criteria

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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