Improving Survivorship Care for Older Adults After Chemotherapy
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|ClinicalTrials.gov Identifier: NCT04405115|
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Survivorship||Behavioral: Geriatric Assessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|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).
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Survivorship Care for Older Adults After Chemotherapy|
|Actual Study Start Date :||February 16, 2021|
|Estimated Primary Completion Date :||May 30, 2025|
|Estimated Study Completion Date :||May 30, 2025|
No Intervention: No intervention arm
routine care only; will not be scheduled for comprehensive geriatric assessment
Active Comparator: Active comparator arm
those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician
Behavioral: Geriatric Assessment
Geriatric Assessment Visit
- Study retention rate [ Time Frame: 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.
- Number of months needed for completion of trial enrollment [ Time Frame: 4-6 months ]
- Acceptability of the study: survey [ Time Frame: 4-6 months ]Assess acceptability via a short survey administered to participating oncology nurse navigators and patients selected for the intervention group.
- Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool [ Time Frame: 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 the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-30 [ Time Frame: 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.
- Health related quality of life assessment by QLQ14 [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405115
|Contact: Joseph Mosholder||559-387-1825||JMosholder@communitymedical.org|
|Contact: Richard Ward||559-387-1828||RWard5@communitymedical.org|
|Principal Investigator:||Haifaa Abdulhaq, MD||University of California, San Francisco|