Improving Survivorship Care for Older Adults After Chemotherapy

Not Applicable

Recruiting

• Conditions: Survivorship
• Interventions: Behavioral: Geriatric Assessment

• Registration Number: NCT04405115
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Study Start: 2021-02-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active comparator arm	Geriatric Assessment	those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician

Primary Outcome Measures

Name	Time	Method
Number of months needed for completion of trial enrollment	4-6 months
Acceptability of the study: survey	4-6 months	Assess acceptability via a short survey administered to participating oncology nurse navigators and patients selected for the intervention group.
Study retention rate	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool	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
Health related quality of life assessment by QLQ14	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)
Self rated patient knowledge and preparedness measured by PLANS assessment tool (Preparing for Life as a New Survivor)	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.
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	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.

Trial Locations

Locations (1)

Community Cancer Institute; 🇺🇸 Clovis, California, United States