Improving Survivorship Care for Older Adults After Chemotherapy

NCT04405115 | Recruiting

• 1 other identifier: 2019028
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Survivorship

Keywords

survivorship care; Chemo; chemotherapy; older; survivor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool

  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

  4-6 months

• Health related quality of life assessment by QLQ14

  4-6 months

• Self rated patient knowledge and preparedness measured by PLANS assessment tool (Preparing for Life as a New Survivor)

  4-6 months

Study Arms (2)

No intervention arm

NO INTERVENTION

routine care only; will not be scheduled for comprehensive geriatric assessment

Active comparator arm

ACTIVE COMPARATOR

those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician

Behavioral: Geriatric Assessment

Interventions

Geriatric Assessment BEHAVIORAL

Geriatric Assessment Visit

Active comparator arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• advanced dementia or serious cognitive impairment that would impede ability to participate in the interview
• nursing home resident.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Community Cancer Institute

Clovis, California, 93611, United States

RECRUITING

MeSH Terms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Haifaa Abdulhaq, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Mosholder

CONTACT

559-387-1825; JMosholder@communitymedical.org

Richard Ward

CONTACT

559-387-1828; RWard5@communitymedical.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms; 1:1 randomization; Standard of care (control group) will receive routine care only and will not be scheduled for a Comprehensive Geriatric Assessments visit. Comprehensive geriatric assessment ( intervention group) will be scheduled for a Comprehensive Geriatric Assessment visit that will take place with a geriatric nurse practitioner of a physician as soon as possible following enrollment and randomization (preferably within 2 weeks).

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: May 28, 2020
• Study Start: February 16, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)