Improving Survivorship Care for Older Adults After Chemotherapy
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Joseph Mosholder
- Phone Number: 559-387-1825
- Email: JMosholder@communitymedical.org
Study Contact Backup
- Name: Richard Ward
- Phone Number: 559-387-1828
- Email: RWard5@communitymedical.org
Study Locations
-
-
California
-
Clovis, California, United States, 93611
- Recruiting
- Community Cancer Institute
-
Contact:
- Joseph Mosholder
- Phone Number: 559-387-1825
- Email: JMosholder@communitymedical.org
-
Contact:
- Richard Ward
- Phone Number: 559-387-1828
- Email: RWard5@communitymedical.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 65 years and above and
- Have diagnosis of cancer and have completed chemotherapy with curative (not palliative) intent and
- have been scheduled to receive a survivorship care plan from an oncology navigator.
Exclusion Criteria:
- advanced dementia or serious cognitive impairment that would impede ability to participate in the interview
- nursing home resident.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: No intervention arm
routine care only; will not be scheduled for comprehensive geriatric assessment
|
|
|
Active Comparator: Active comparator arm
those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician
|
Geriatric Assessment Visit
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study retention rate
Time Frame: 4-6 months
|
Feasibility of the study will be assessed by study retention rate which is defined as proportion of enrolled participants who remain enrolled until study completion.
|
4-6 months
|
|
Number of months needed for completion of trial enrollment
Time Frame: 4-6 months
|
4-6 months
|
|
|
Acceptability of the study: survey
Time Frame: 4-6 months
|
Assess acceptability via a short survey administered to participating oncology nurse navigators and patients selected for the intervention group.
|
4-6 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool
Time Frame: 4-6 months
|
PSCC items are rated on 5-point Likert scales: "1 = Strongly Agree", "2 = Agree", "3 = Neutral", "4 = Disagree", and "5 = Strongly Disagree".
A lower PSCC total score indicates higher satisfaction level
|
4-6 months
|
|
Health related quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-30
Time Frame: 4-6 months
|
The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer.
The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent).
The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.
|
4-6 months
|
|
Health related quality of life assessment by QLQ14
Time Frame: 4-6 months
|
QLQ-ELD14 is a validated quality of life questionnaire for cancer patients aged ⩾70 years and it is used in conjunction with EORTC QLQ-30.QLQ-ELD14 comprises five scales (mobility, worries about others, future worries, maintaining purpose and burden of illness) and two single items (joint stiffness and family support)
|
4-6 months
|
|
Self rated patient knowledge and preparedness measured by PLANS assessment tool (Preparing for Life as a New Survivor)
Time Frame: 4-6 months
|
Preparing for Life as a New Survivor (PLANS) survey is utilized to evaluate survivor satisfaction with 1) own knowledge of diagnosis, treatment, and side effects, and 2) communication with the cancer team regarding diagnosis, treatment, and side effects.PLANS questions assess the level of agreement with statements regarding satisfaction with a 4-point scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree) for each statement.
|
4-6 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Haifaa Abdulhaq, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Population Characteristics
- Health Status
- Demography
- Epidemiologic Measurements
- Geriatric Assessment
Other Study ID Numbers
Other Study ID Numbers
- 2019028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.