Improving Survivorship Care for Older Adults After Chemotherapy

The researchers want to find out if older adults receiving a survivorship care plan followed by a geriatric assessment visit improves quality of life and satisfaction with care compared to receiving only a survivorship care plan for older adults who have completed chemotherapy for cancer treatment.

Study Overview

• Status: Recruiting
• Conditions: Survivorship
• Intervention / Treatment: Behavioral: Geriatric Assessment

Detailed Description

This study is a pilot randomized trial to examine whether a geriatric assessment-enhanced survivorship care plan improves satisfaction, knowledge and health-related quality of life compared to standard survivorship care plans among older adults who have completed curative chemotherapy for cancer. The investigator's hypothesis is that older adults who receive a geriatric assessment-enhanced survivorship care plan will report improved satisfaction with care, health-related quality of life, and knowledge and preparedness for survivorship care needs.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• 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

• United States
  • 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

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age 65 years and above and
2. Have diagnosis of cancer and have completed chemotherapy with curative (not palliative) intent and
3. have been scheduled to receive a survivorship care plan from an oncology navigator.

Exclusion Criteria:

1. advanced dementia or serious cognitive impairment that would impede ability to participate in the interview
2. 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

2

Arms and Interventions

Participant Group / Arm	Intervention / 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	Behavioral: Geriatric Assessment; Geriatric Assessment Visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study retention rate	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		4-6 months
Acceptability of the study: survey	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

Outcome Measure	Measure Description	Time Frame
Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool	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	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	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)	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: University of California, San Francisco
• Investigators: Principal Investigator: Haifaa Abdulhaq, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Anticipated): May 30, 2025
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: chemotherapy; older; survivor; survivorship care; Chemo
• Other Study ID Numbers: 2019028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No