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Recruiting

NCT Number: NCT04405115

Improving Survivorship Care for Older Adults After Chemotherapy

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.

Recruiting

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Key information

Conditions

Survivorship

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Geriatric Assessment

Behavioral

Geriatric Assessment Visit

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Mosholder

CONTACT

[email protected]

559-387-1825

Richard Ward

CONTACT

[email protected]

559-387-1828

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 28, 2020
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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