Improving Survivorship Care for Older Adults After Chemotherapy
ConditionSurvivorship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
advanced dementia or serious cognitive impairment that would impede ability to participate in the interview
nursing home resident.
Trial design
Design model
Parallel
Treatments tested in this trial
Geriatric Assessment
BehavioralGeriatric Assessment Visit
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: No intervention armNo intervention 0 interventions
Group B: Active comparator armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4-6 months2
Number of months needed for completion of trial enrollment
Time frame
4-6 months3
Acceptability of the study: survey
Assess acceptability via a short survey administered to participating oncology nurse navigators and patients selected for the intervention group.
Time frame
4-6 monthsSecondary outcomes
1
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
Time frame
4-6 months2
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.
Time frame
4-6 months3
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)
Time frame
4-6 months4
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.
Time frame
4-6 monthsSponsors and contacts
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Source ClinicalTrials.gov