SurvivorshipNCT04405115
Improving Survivorship Care for Older Adults After Chemotherapy
A study testing Geriatric Assessment in people with Survivorship, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Survivorship
- What is being tested?
- Geriatric Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2021to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- advanced dementia or serious cognitive impairment that would impede ability to participate in the interview
- nursing home resident.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Community Cancer Institute
Clovis, California, 93611
Joseph Mosholder, 559-387-1825, JMosholder@communitymedical.org
Richard Ward, 559-387-1828, RWard5@communitymedical.org
About this study
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.
Read the 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.
- Conditions
- Survivorship
- Being tested
- Geriatric Assessment
- Keywords
- survivorship care, Chemo, chemotherapy, older, survivor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric AssessmentBehavioural
Geriatric Assessment Visit
| Study group | Role | What they receive |
|---|---|---|
| No intervention arm | No intervention | routine care only; will not be scheduled for comprehensive geriatric assessment |
| Active comparator arm | Active comparator | those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician Receives: Behavioral: Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 months
Number of months needed for completion of trial enrollment
Measured: 4-6 months
Acceptability of the study: survey
Assess acceptability via a short survey administered to participating oncology nurse navigators and patients selected for the intervention group.
Measured: 4-6 months
Secondary outcomes (4)
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
Measured: 4-6 months
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.
Measured: 4-6 months
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)
Measured: 4-6 months
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.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start16 Feb 2021
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haifaa Abdulhaq, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405115
- Sponsor's protocol ID
- 2019028
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2020
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Survivorship Care for Older Adults After Chemotherapy
- ClinicalTrials.gov ID
- NCT04405115
- Acronym / sponsor ID
- 2019028
- Conditions
- Survivorship
- Keywords
- survivorship care, Chemo, chemotherapy, older, survivor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| No intervention arm | No intervention | –routine care only; will not be scheduled for comprehensive geriatric assessment |
| Active comparator arm | Active comparator | Behavioral: Geriatric Assessmentthose that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- advanced dementia or serious cognitive impairment that would impede ability to participate in the interview
- nursing home resident.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric AssessmentGeriatric Assessment Visit | Behavioural | Active comparator arm |
Primary outcome
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.
4 secondary outcomes
Patient satisfaction assessment by PSCC (Patient Satisfaction with Cancer related Care) tool
Time frame: 4-6 months
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
Health related quality of life assessment by QLQ14
Time frame: 4-6 months
Self rated patient knowledge and preparedness measured by PLANS assessment tool (Preparing for Life as a New Survivor)
Time frame: 4-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haifaa Abdulhaq, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Assessment in people with Survivorship, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Mosholder (559-387-1825, JMosholder@communitymedical.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study retention rate (time frame: 4-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.