Clinical trial NCT04405115: Improving Survivorship Care for Older Adults After Chemotherapy
Official title: Improving Survivorship Care for Older Adults After Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Survivorship
Keywords: survivorship care
Chemo
chemotherapy
older
survivor
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study retention rate
timeFrame: 4-6 months
measure: Number of months needed for completion of trial enrollment
timeFrame: 4-6 months
measure: Acceptability of the study: survey
timeFrame: 4-6 months
Secondary outcomes:
measure: Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool
timeFrame: 4-6 months
measure: Health related quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-30
timeFrame: 4-6 months
measure: Health related quality of life assessment by QLQ14
timeFrame: 4-6 months
measure: Self rated patient knowledge and preparedness measured by PLANS assessment tool (Preparing for Life as a New Survivor)
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Clovis
country: United States
facility: Community Cancer Institute
state: California
Study officials:
affiliation: University of California, San Francisco
name: Haifaa Abdulhaq, MD
role: PRINCIPAL_INVESTIGATOR
References: