Care Transition Intervention for Patients With Cancer

Browse trials for

• Neoplasms 9,365

Keywords

• Advanced Cancer
• Home Care, Hospital-Based
• Transitions of Care
• Care Transition Intervention

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 58 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Study arms

• Experimental
  CONTINUity of care Under Management by Video visits (CONTINUUM-V)

  Participants with advanced cancer will receive a video visit conducted by an oncology Nurse Practitioner (NP) within three (3) business days of hospital discharge. The visit will involve: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team. Participant and clinician may also be interviewed for their feedback on the video visit. The ultimate goal of the intervention is to improve patients' confidence in managing their health condition and reduce burdensome health care utilization after discharge, particularly reducing 30-day hospital readmissions.

  Behavioral: CONTINUity of care Under Management by Video visits (CONTINUUM-V)

Interventions

• BehavioralCONTINUity of care Under Management by Video visits (CONTINUUM-V)

  Video visit by nurse practitioner within 3 business days of hospital discharge.

Primary outcomes

1. Feasibility using enrollment and retention on study

   The intervention will be deemed feasible if at least 70% of eligible patients participate in the study, and if at least 70% complete the video visit within three business days of discharge.

   Time frame: Discharge to 3 business days

Secondary outcomes

1. Patients' Confidence in Managing their Health Condition using the Patient Activation Measure (PAM-13)

   The investigators will use the Patient Activation Measure 13 (PAM-13) to assess participants' confidence in managing their health condition at baseline and within 10-15 days of discharge (post-intervention). The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition.

   Time frame: Baseline to 15 days after discharge

2. Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)

   The investigators will use a modified version of the self-administered, revised Edmonton Symptom Assessment System (ESAS-r) to assess participants' symptoms at baseline and within 10-15 days of discharge (post-intervention). The ESAS-r assesses pain, fatigue, drowsiness, nausea, appetite, dyspnea, depression, anxiety, and well being over the previous 24 hours. The ESAS-r also includes constipation. Individual symptoms are scored on a scale from 0 (reflecting absence of the symptom) to 10 (reflecting the worst possible severity). The investigators will compute the composite ESAS physical and total symptom variables that included scores of participants' physical symptoms (pain, fatigue, drowsiness, nausea, appetite, dyspnea, constipation) and total symptoms (pain, fatigue, drowsiness, nausea, appetite, dyspnea, depression, anxiety, well being, constipation).

   Time frame: Baseline to 15 days after discharge

3. Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)

   The investigators will use the Patient Health Questionnaire-4 (PHQ-4) to assess psychological symptoms at baseline and within 10-15 days of discharge (post-intervention). The PHQ-4 is a 4-item tool that contains two 2-item subscales assessing depression and anxiety symptoms. Both subscales and the composite PHQ-4 score can also be evaluated continuously, with higher scores indicating worse psychological distress. Scores on each subscale range from 0 to 6.

   Time frame: Baseline to 15 days after discharge

4. Patient Satisfaction using the Patient Satisfaction Questionnaire

   The investigators will use the patient satisfaction questionnaire within 10-15 days after discharge. The participants will be asked how useful the participants found the intervention, on a 0 to 10 scale, with 0 being not useful at all and 10 being extremely useful.

   Time frame: 10 to 15 days after discharge

Other outcomes

1. 30-day Hospital Readmissions

   The investigators will assess whether study participants had a hospital re-admission within 30 days of discharge using the Electronic Health Record

   Time frame: Discharge to 30 days after discharge

Individual participant data

Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Supporting information: Study protocol, Sap, Icf