Improving Survivorship Care for Older Adults After Chemotherapy

Survivorship Clinical Trial

Official title:

Improving Survivorship Care for Older Adults After Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405115
• Other study ID #: 2019028
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: May 30, 2025

Study information

• Verified date: April 2023
• Source: University of California, San Francisco
• Contact: Joseph Mosholder
• Phone: 559-387-1825
• Email: JMosholder[@]communitymedical.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Survivorship

Intervention

Behavioral:
• Geriatric Assessment
Geriatric Assessment Visit

Locations

Country	Name	City	State
United States	Community Cancer Institute	Clovis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of months needed for completion of trial enrollment		4-6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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