CaregiverNCT04085081
Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers
A study testing E-mail, Exercise Intervention and Quality-of-Life Assessment in people with Caregiver and Lobectomy Patient, run by City of Hope Medical Center.
Trial summary
This trial studies whether a telephone-based physical activity intervention before and after lung cancer surgery can be provided to older patients and their caregivers. The trial also aims to understand whether patients and family caregivers will be satisfied with the intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Lobectomy Patient, Lung Carcinoid Tumor
- What is being tested?
- E-mail, Exercise Intervention and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS: Must have histologically confirmed non-small cell lung cancer (NSCLC) or carcinoid tumor of the lung, and registration must occur after the first histologic diagnosis
- PATIENTS: Must be registered at least 15 days before their scheduled surgery
- PATIENTS: Must be scheduled for a lobectomy (open or minimally invasive)
- PATIENTS: Must have access to a smartphone or telephone for study intervention sessions and study text messages
- PATIENTS: Age >= 70 years
- PATIENTS: Must be willing to wear a wristband pedometer for the duration of the study period, except on day of surgery
Show all 16Show fewer
- PATIENTS: Must be willing to answer telephone calls from the City of Hope Call Center
- PATIENTS: Must have an identified family member or friend who is enrolled in the study
- PATIENTS: Able to read and comprehend English. Study materials and telephone calls are only available in English
- FAMILY CAREGIVERS: Family member or friend identified by the patient and will be caring for the patient before and after surgery
- FAMILY CAREGIVERS: Age >= 18 years
- FAMILY CAREGIVERS: Must have access to a smartphone or telephone for study intervention sessions and study text messages
- FAMILY CAREGIVERS: Must be willing to wear a wristband pedometer for the duration of the study period
- FAMILY CAREGIVERS: Must be willing to answer telephone calls from the City of Hope Call Center
- FAMILY CAREGIVERS: Must have a care recipient (patient) who is enrolled in the study
- FAMILY CAREGIVERS: Able to read and comprehend English. Study materials and telephone calls are only available in English
Who cannot join
None listed.
About this study
Official title: Feasibility of a Perioperative Physical Activity Intervention for Older Adults With Lung Cancer and Their Family Caregivers
This trial studies whether a telephone-based physical activity intervention before and after lung cancer surgery can be provided to older patients and their caregivers. The trial also aims to understand whether patients and family caregivers will be satisfied with the intervention. Participating in physical activity such as walking before and after lung cancer surgery may improve functional status and recovery in older patients and their family caregivers.
Read the detailed description
PRIMARY OBJECTIVE:
- Administer and determine the feasibility of the perioperative physical activity intervention.
SECONDARY OBJECTIVES:
- To describe patient and family caregiver outcome patterns and trajectory pre- and post-intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention through brief, semi-structured interviews with patients and family caregivers.
OUTLINE:
Patients and family caregivers complete comprehensive geriatric and functional assessments before surgery. This information is used to develop a personalized walking program plus simple lower extremity strength exercises. The intervention is administered by trained coaches with physical and occupational therapy background. The sessions are delivered by telephone before surgery (30-60 minutes), and on days 2, 7, 14, and 21 after hospital discharge (20-50 minutes). Participants will also receive brief motivational text or email messages (4 times per week between telephone sessions) to provide support, promote physical activity behavior change, and to sustain participant engagement.
Patients and family caregivers are followed up to day 30 after hospital discharge.
- Being tested
- E-mail, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration, Telephone-Based Intervention
- Keywords
- Lung cancer, geriatric oncology, physical activity, family caregivers, functional status
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-mailOther
Also called Electronic Mail, Email
Receive brief motivational text or email messages
Exercise InterventionBehavioural
Receive personalized walking program plus strength exercises
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive intervention coaching sessions via telephone
Text MessageOther
Also called SMS Text, SMS Text Message, Text
Receive brief motivational text or email messages
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (coaching call, motivational messages) | Experimental | Patients and family caregivers complete comprehensive geriatric and functional assessments before surgery. This information is used to develop a personalized walking program plus simple lower extremity strength exercises. The intervention is administered by trained coaches with physical and occupational therapy background. The sessions are delivered by telephone before surgery (30-60 minutes), and on days 2, 7, 14, and 21 after hospital discharge (20-50 minutes). Participants will also receive brief motivational text or email messages (4 times per week between telephone sessions) to provide support, promote physical activity behavior change, and to sustain participant engagement. Receives: Other: E-mail; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Other: Text Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of >= 70% of eligible participants
Will be evaluated based on data obtained throughout the study. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.
Measured: Up to 30 days post-hospital discharge
>= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists
Will be evaluated based on data obtained throughout the study. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.
Measured: Up to 30 days post-hospital discharge
Adherence/engagement
Will be determined by >= 70% of enrolled participants who complete at least 2 intervention sessions. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.
Measured: Up to 30 days post-hospital discharge
Secondary outcomes (1)
Intervention acceptability as reported by participants
Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach.
Measured: Up to 30 days post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start15 May 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Why it stopped: Funding issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Virginia Sun, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085081
- Sponsor's protocol ID
- 19252
- Other IDs
- NCI-2019-05582, 19252
- Status last verified
- Aug 2021
- First submitted
- 9 Sep 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Perioperative Physical Activity Intervention for Older Adults With Lung Cancer and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT04085081
- Acronym / sponsor ID
- 19252
- Keywords
- Lung cancer, geriatric oncology, physical activity, family caregivers, functional status
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 11 Sep 2019 (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.
This trial studies whether a telephone-based physical activity intervention before and after lung cancer surgery can be provided to older patients and their caregivers. The trial also aims to understand whether patients and family caregivers will be satisfied with the intervention. Participating in physical activity such as walking before and after lung cancer surgery may improve functional status and recovery in older patients and their family caregivers.
Detailed description
PRIMARY OBJECTIVE:
- Administer and determine the feasibility of the perioperative physical activity intervention.
SECONDARY OBJECTIVES:
- To describe patient and family caregiver outcome patterns and trajectory pre- and post-intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention through brief, semi-structured interviews with patients and family caregivers.
OUTLINE:
Patients and family caregivers complete comprehensive geriatric and functional assessments before surgery. This information is used to develop a personalized walking program plus simple lower extremity strength exercises. The intervention is administered by trained coaches with physical and occupational therapy background. The sessions are delivered by telephone before surgery (30-60 minutes), and on days 2, 7, 14, and 21 after hospital discharge (20-50 minutes). Participants will also receive brief motivational text or email messages (4 times per week between telephone sessions) to provide support, promote physical activity behavior change, and to sustain participant engagement.
Patients and family caregivers are followed up to day 30 after hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (coaching call, motivational messages) | Experimental | Other: E-mail, Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Behavioral: Telephone-Based Intervention, Other: Text MessagePatients and family caregivers complete comprehensive geriatric and functional assessments before surgery. This information is used to develop a personalized walking program plus simple lower extremity strength exercises. The intervention is administered by trained coaches with physical and occupational therapy background. The sessions are delivered by telephone before surgery (30-60 minutes), and on days 2, 7, 14, and 21 after hospital discharge (20-50 minutes). Participants will also receive brief motivational text or email messages (4 times per week between telephone sessions) to provide support, promote physical activity behavior change, and to sustain participant engagement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- PATIENTS: Must have histologically confirmed non-small cell lung cancer (NSCLC) or carcinoid tumor of the lung, and registration must occur after the first histologic diagnosis
- PATIENTS: Must be registered at least 15 days before their scheduled surgery
- PATIENTS: Must be scheduled for a lobectomy (open or minimally invasive)
- PATIENTS: Must have access to a smartphone or telephone for study intervention sessions and study text messages
- PATIENTS: Age >= 70 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| E-mailAlso: Electronic Mail, EmailReceive brief motivational text or email messages | Other | Supportive care (coaching call, motivational messages) |
| Exercise InterventionReceive personalized walking program plus strength exercises | Behavioural | Supportive care (coaching call, motivational messages) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (coaching call, motivational messages) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (coaching call, motivational messages) |
| Telephone-Based InterventionReceive intervention coaching sessions via telephone | Behavioural | Supportive care (coaching call, motivational messages) |
| Text MessageAlso: SMS Text, SMS Text Message, TextReceive brief motivational text or email messages | Other | Supportive care (coaching call, motivational messages) |
Primary outcome
Enrollment of >= 70% of eligible participants
Time frame: Up to 30 days post-hospital discharge
Will be evaluated based on data obtained throughout the study. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.
>= 70% of enrolled participants who answer the telephone calls from City of Hope interventionists
Time frame: Up to 30 days post-hospital discharge
Will be evaluated based on data obtained throughout the study. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.
Adherence/engagement
Time frame: Up to 30 days post-hospital discharge
Will be determined by >= 70% of enrolled participants who complete at least 2 intervention sessions. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables.
1 secondary outcome
Intervention acceptability as reported by participants
Time frame: Up to 30 days post-hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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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. This study is not recruiting at the moment.
Virginia Sun principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing E-mail, Exercise Intervention and Quality-of-Life Assessment in people with Caregiver and Lobectomy Patient, run by City of Hope Medical Center.
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 16 inclusion and 0 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: withdrawn, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of >= 70% of eligible participants (time frame: Up to 30 days post-hospital discharge). 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 12 Aug 2021.