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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Survivorship Behavioral: Geriatric Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Number of months needed for completion of trial enrollment [ Time Frame: 4-6 months ]
  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Joseph Mosholder 559-387-1825 JMosholder@communitymedical.org
Contact: Richard Ward 559-387-1828 RWard5@communitymedical.org

Locations
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United States, California
Community Cancer Institute Recruiting
Clovis, California, United States, 93611
Contact: Joseph Mosholder    559-387-1825    JMosholder@communitymedical.org   
Contact: Richard Ward    559-387-1828    RWard5@communitymedical.org   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Haifaa Abdulhaq, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04405115    
Other Study ID Numbers: 2019028
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
survivorship care
Chemo
chemotherapy
older
survivor