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NCT Number: NCT02222259

A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients

The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.

Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genitourinary Cancer Male Urogenital Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5T 2M9, Canada

About this study

Introduction: A comprehensive geriatric assessment (CGA) can identify functional and psychosocial issues in older cancer patients, which in turn can inform interventions to prevent/postpone adverse outcomes and maintain/improve the functional status and well-being of this population. However, few randomized controlled trials (RCTs) have been completed showing the evidence.

OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast, gastrointestinal or genitourinary cancer METHODS -

A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above, diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified. Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan, and again at 3 and 6 months to assess intervention fidelity and measure outcomes. The co-primary outcomes are: 1) maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.

Recruitment has been completed November 2015

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of advanced (stage 2, 3 or 4) Gastrointestinal, Genitourinary, or breast cancer
  • Referred for first-line chemotherapy
  • Ability to speak English
  • Physician estimated life expectancy >6 months
  • An Eastern Oncology Group Collaborative (ECOG) Performance Score of 0-2
  • Ability to provide informed consent

Exclusion criteria

  • Previous chemotherapy for current stage of disease

Treatment and study plan

GA and Integrated Care Plan

Procedure

The intervention will consist of a Geriatric Assessment conducted by a multidisciplinary geriatric oncology team followed by an integrated care plan developed and implemented by the team for those issues identified in the assessment. The study intervention includes contact with the intervention team at 4 points in time during the study: at baseline (to conduct the assessment and develop the integrated care plan), 2-3 weeks by telephone after the clinic visit to evaluate if the plan needs adjustments, at 3 and 6 months (to evaluate the outcomes of the integrated care plan; i.e., did the patient follow all recommendations of the integrated care plan and did the plan lead to the desired outcomes for the problems identified?

Primary outcomes

  1. Quality of life

    Time frame: 6 months

    We will measure quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core version 30 items (EORTC QLQ C30)

Secondary outcomes

  1. Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire

    Time frame: 6 months

    The treating oncologist will be asked to indicate the cancer treatment plan prior to receiving the geriatric assessment results using a survey previously used in the study of Dr. Alibhai et al (Am J Clin Oncol. 2012 Aug;35(4):322-8.).

    After the GA the results will be send to the treating oncologist and after the physician will be asked to indicate whether or not and if yes how he/she modified the treatment plan based on the GA results

  2. Functional status

    Time frame: 6 months

    We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2014
Registry last updated
Apr 11, 2018

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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