Project ENABLE II

Highlights
Program Title Project ENABLE II
Purpose Designed to enhance the quality of life for cancer survivors. (2009)
Program Focus Psychosocial - Coping
Population Focus Cancer Survivors
Topic Survivorship/Supportive Care
Age This information has not been reported.
Gender This information has not been reported.
Race/Ethnicity This information has not been reported.
Setting This information has not been reported.
Origination United States
Funded by NCI (Grant number(s): R01CA101704)
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RE-AIM Scores
This program has been evaluated on criteria from the RE-AIM framework, which helps translate research into action.
Details about Reach
Reach
100.0%
Details about Effectiveness
Effectiveness
100.0%
Details about Adoption
Adoption
16.7%
Details about Implementation
Implementation
71.4%
The Need
The American Cancer Society estimates that 11.1 million Americans were living with cancer in 2005, and that 1.5 million new cases of cancer were diagnosed in 2009. Fifty percent of persons with cancer are not cured of their disease, and each year more than a half million people die of cancer in the United States.  However, with improved treatment, even patients with advanced disease may live for years. Providing palliative care at the same time as oncology treatment (e.g., chemotherapy, radiation) has been proposed to improve quality of life for patients with advanced cancer. Palliative care can be defined as holistic care that aims to relieve physical, emotional, and spiritual suffering and improve quality of life in patients with life-limiting illnesses and their families. A palliative approach promotes identification of individual values and preferences for care, open communication between patients and their care providers, control of distressing symptoms, and family involvement. The National Consensus Project Clinical Practice Guidelines for Quality Palliative Care recommends a concurrent care model that integrates palliative care services into standard oncology practice at the time of a life-threatening diagnosis. Studies evaluating palliative care interventions for patients with cancer have demonstrated improvements in patients’ quality of life, depression, and symptom severity. In addition, patient-directed palliative care interventions might help caregivers indirectly by improving patient outcomes.
The Program
Description
Project ENABLE (“Educate, Nurture, Advise Before Life Ends”) uses a case management, educational approach to encourage patient activation, self-management, and empowerment among individuals with a new diagnosis of advanced stage or recurrent cancer. The manualized, telephone-based intervention is designed to improve problem-solving skills, symptom management, and communication skills, as well as to promote advance care planning (e.g., advanced directives and “do not resuscitate” orders). The intervention is provided soon after diagnosis and concurrent with cancer treatment. An advanced practice nurse with palliative care specialty training conducts four initial educational and problem-solving telephone sessions. Each session covers one of four modules, in sequence: problem solving, communication and social support, symptom management, advance care planning and unfinished business. Each telephone contact begins by identifying any sources of distress in five areas of practical problems: work or school, family problems, emotional problems, spiritual or religious concerns, and physical problems. After problem solving for each distressing situation, if indicated, the nurse covers the assigned module for that session. After the fourth session, the advanced practice nurse contacts the participant or caregiver at least monthly until the participant’s death to follow up on active issues and to assess the need for referral to appropriate care resources (e.g., palliative care team, hospice).
Implementation Guide

The Implementation Guide is a resource for implementing this program. It provides important information about the staffing and functions necessary for administering this program in the user's setting. Additionally, the steps needed to carry out the research-tested program, relevant program materials, and information for evaluating the program are included. The Implementation Guide can be viewed and downloaded in the Products page.

Time Required
Four initial sessions are conducted weekly and last an average of 30–40 minutes. Monthly follow-up telephone calls last an average of 12 minutes each.
Intended Audience
Project ENABLE II is intended for patients who are newly diagnosed with advanced cancer.
Suitable Settings
Project ENABLE II can be implemented in medical centers and cancer centers.
Required Resources

Required resources to implement the program include the following:
- ENABLE II Intervention Outline
- ENABLE II Nurse Educator Intervention Manual
- ENABLE II Charting Your Course Patient Manual
- Fidelity Checklist
- National Comprehensive Cancer Network (NCNN) Distress Thermometer
- OPTIONAL: Shared Medical Appointment (SMA) Tools:
     - Coordination of the SMAs
     - Shared Medical Appointment Evaluation Form
     - SMA-GMA Reliability Checklist

For costs associated with this program, please contact the developer, Marie Bakitas. (See products page on the RTIPs website for developer contact information.)

About the Study

Patients recruited for the study were newly diagnosed with advanced cancer (prognosis of approximately 1 year of life expectancy). Diagnoses included gastrointestinal tract, lung, genitourinary tract, or breast cancer. Upon return of the baseline assessment, patients and their caregivers were randomly assigned, stratified by disease and blocked within strata, to receive the intervention or usual care. Participants assigned to usual care were allowed to use all oncology and supportive services without restrictions, including referral to palliative care services.

The study included 322 participants, 161 in the intervention group and 161 in the control group. The average age of the participants was 65.1 years. The sample was 58.1% male and 85.4% White; race data were missing for 13.4% of the sample.

Quality of life was measured using the Functional Assessment of Chronic Illness Therapy for Palliative Care. This 46-item tool measures physical, emotional, social, and functional well-being in addition to concerns relevant to persons with life-threatening illness (e.g., feeling peaceful, reconciling with others). Scores for this tool range from 0 to 184, and higher scores indicate better quality of life. Mood was measured using the Center for Epidemiological Studies Depression Scale (CES-D), a 20-item measure with scores from 0 to 60. A score of 16 or higher generally indicates a clinically significant level of depressed mood. Measures were assessed at baseline, 1 month, and every 3 months thereafter until the participant’s death or study completion.

Key Findings

(Graph of Study Results) 

  • Longitudinal intention-to-treat analyses found that over time, participants in the intervention group had higher quality of life scores on average compared with participants in the control group (p=.02).

 

(Graph of Study Results)

  • Longitudinal intention-to-treat analyses found that over time, participants in the intervention group reported having lower mood scores (indicating less depressed mood) on average compared with participants in the control group (p=.02).

 

Additional Findings

  • Although there was a trend toward lower symptom intensity over time in the intervention group compared with the control group, the difference was not significant.
Publications
Primary
Secondary

Maloney C, Lyons KD, Li Z, Hegel M, Ahles TA, Bakitas M. (2013). Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens. Palliative Medicine, 27 (4), 375-383.

Bakitas M, Lyons KD, Hegel MT, Ahles T. (2012). Oncologists' perspectives on concurrent palliative care in a National Cancer Institute-designated comprehensive cancer center. Palliative Medicine, 8 , 1-9.

O'Hara RE, Hull JG, Lyons KD, Bakitas M, Hegel MT, Li Z, Ahles TA. (2010). Impact on caregiver burden of a patient-focused palliative care intervention for patients with advanced cancer. Palliative & Supportive Care, 8 (4), 395-404.

Bakitas M, Lyons KD, Hegel MT, Balan S, Barnett KN, Brokaw FC, Byock IR, Hull JG, Li Z, McKinstry E, Seville JL, Ahles TA. (2009). The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions. Palliative & Supportive Care, 7 (1), 75-86.

Lyons KD, Bakitas M, Hegel MT, Hanscom B, Hull J, Ahles TA. (2009). Reliability and validity of the Functional Assessment of Chronic Illness Therapy-Palliative care (FACIT-Pal) scale. Journal of Pain and Symptom Management, 37 (1), 23-32.

Bakitas MA, Lyons KD, Dixon J, Ahles TA. (2006). Palliative care program effectiveness research: developing rigor in sampling design, conduct, and reporting. Journal of Pain and Symptom Management, 31 (3), 270-284.

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Updated: 09/25/2014