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Completed

NCT Number: NCT02810652

Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

The purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.

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Key information

Conditions

Pancreatic Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hepatobiliary Cancer Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Stomach Diseases Stomach Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

About this study

In the proposed study, the investigators will conduct a randomized controlled trial of a perioperative geriatrics intervention versus usual care in older patients with gastrointestinal (GI) cancers undergoing surgical resection. The perioperative geriatrics intervention will entail pre- and post-operative geriatric care for patients age ≥65 undergoing surgery for gastrointestinal cancers. Specifically, geriatric clinicians will evaluate and manage patients preoperatively in the outpatient setting and postoperatively in the inpatient setting as a consultant.

The investigators will evaluate the effect of the perioperative geriatrics intervention on postoperative length of stay (primary outcome) and readmissions in a sample of 160 patients. The investigators will also assess the impact of the perioperative geriatrics intervention on patient-reported outcomes, including quality of life (QOL) and symptom burden.

The study will take place at Massachusetts General Hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 or older
  • Diagnosed with pancreatic, esophageal, rectal, colon, hepatobiliary, or gastric cancer (including patients with prior diagnosis of another cancer)
  • Planning to receive surgical resection at MGH (including both curative and palliative resections)
  • Verbal fluency in English

Exclusion criteria

  • Unwilling or unable to participate in the study
  • Significant uncontrolled psychiatric disorder (e.g. psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g. dementia, cognitive impairment) which the treating clinician believes prohibits informed consent or participation in the study

Treatment and study plan

Usual Care

Other

Usual Care participants will not meet with a geriatric clinician perioperatively, though they may receive a geriatric consult at their request or at the discretion of their treating cancer team.

Perioperative Geriatrics Intervention

Other

Patients randomized to the perioperative geriatrics intervention will undergo evaluation with a board-certified Massachusetts General Hospital (MGH) geriatric clinician, both pre- and post-operatively. The geriatric clinician visits will focus on the following issues: comorbidity, polypharmacy, nutrition, physical and mental function, and social support.

Primary outcomes

  1. Hospital Length Of Stay

    Time frame: 2 years

    Hospital length of stay from admission to discharge

Secondary outcomes

  1. 30-day readmission rate

    Time frame: 2 years

    Defined as the first hospital readmission within 30 days of prior hospital discharge, if patients are readmitted

  2. Time to readmission

    Time frame: 2 years

    Defined as time from discharge to first readmission.

  3. Change In patients' QOL From Baseline To Post-Intervention

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

  4. Change In Patients' Symptom Scores From Baseline To Post-Intervention

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    Edmonton Symptom Assessment System (ESAS) symptom scores measured continuously

  5. Change In Patients' Depression From Baseline To Post-Intervention

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    As per Geriatric Depression Scale (GDS) measured continuously

  6. Rates Of Post-Intervention Depression Symptoms

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    Defined as presence of GDS scores > 5

  7. Rates Of Post-Intervention Moderate/Severe Symptoms

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    Defined as presence of Edmonton Symptom Assessment System (ESAS) scores ≥4

  8. Change In Activities of Daily Living (ADLs) / Instrumental Activities of Daily Living (IADLs) From Baseline To Post-Intervention

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    As per the Medical Outcomes Study (MOS) and the Older American Resources and Services (OARS) measured continuously

  9. Change In The Number Of Falls During The Past 6 Months (measured continuously) From Baseline To Post-Intervention.

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    Patient self-report of falls

  10. Rates Of Post-Intervention Activity of Daily Living (ADL) Deficits

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    Defined as presence of any Activity of Daily Living (ADL) deficit

  11. Rates Of Post-Intervention Instrumental Activity of Daily Living (IADL) Deficits

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    Defined as presence of any Instrumental Activity of Daily Living (IADL) deficit

  12. Rates Of Post-Intervention Falls

    Time frame: For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)]

    Defined as presence of any falls

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Jun 23, 2016
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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