Lung CancerNCT04885439
NextSteps Intervention for Advanced Cancer Patients and Caregivers
A study testing NextSteps in people with Lung Cancer and Gastrointestinal Cancer, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study seeks to test the efficacy of a psychosocial intervention to empower advanced cancer patients and their caregivers and improve their quality of life (QOL). The program, called NextSTEPS, provides skills training in six domains that are central to patient and caregiver QOL: self-care, stress management… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Gastrointestinal Cancer
- What is being tested?
- NextSteps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 30 Jun 2021
- 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
- Patient has stage 3A, 3B, or 4 NSLC or extensive stage SCLC and is within one month of treatment initiation OR patient has Stage 4 GI cancer and is within one month of treatment initiation
- patient is spending more than 50% of time out of bed on a daily basis as measured by an ECOG Performance Status rating of level 0, 1, or 2
- patient has stable brain metastases and no limitation on hepatic or renal function
- patient has a spouse/partner other or close family member who he/she defines as the primary caregiver
- patient and caregiver are age 18 years or older
- patient and caregiver have the ability to read and understand English at a sixth grade level, as determined by ability to understand the consent form
- patient and caregiver can provide informed consent
Who cannot join
- patient or caregiver is deaf or has significant hearing impairment and thus cannot use the telephone
- patient is currently enrolled in hospice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NextSteps: A Supportive Care Program For Advanced Cancer Patients and Their Caregivers
This study seeks to test the efficacy of a psychosocial intervention to empower advanced cancer patients and their caregivers and improve their quality of life (QOL). The program, called NextSTEPS, provides skills training in six domains that are central to patient and caregiver QOL: self-care, stress management, symptom management, effective communication, problem-solving, and social support.
Read the detailed description
In this study, 200 advanced cancer patients who are within one month of treatment initiation (baseline) and their caregivers will complete baseline surveys and be randomized to NextSTEPS or a usual medical care (UMC) condition. In addition to UMC, patients and caregivers in the NextSTEPS condition will each receive an intervention manual and six weekly 45-minute telephone counseling sessions with a trained interventionist. Patients and caregivers in both the NextSTEPS and UMC conditions will complete follow-up surveys at 8 weeks (primary endpoint), and 4 and 6 months post-baseline (secondary endpoints).
The specific aims are to:
- Determine the impact of NextSTEPS on patient physical and emotional QOL, palliative care utilization, and satisfaction with care relative to UMC. We hypothesize that at 8 weeks (2 months), and 4 and 6 months, patients in NextSTEPS will have less symptom burden, less emotional distress, greater palliative care utilization, and greater satisfaction with care relative to patients in UMC.
- Determine the impact of NextSTEPS on caregiver self-care, physical and emotional QOL, and satisfaction with care. We hypothesize that at 8 weeks, and 4 and 6 months, caregivers in NextSTEPS will report more self-care, better physical QOL, less emotional distress, and greater satisfaction with care relative to caregivers in UMC.
Secondary/exploratory aims and hypotheses are to:
Examine the effects of the NextSTEPS intervention on Self Determination Theory (SDT) constructs. We hypothesize that NextSTEPS will enhance patient and caregiver competence, autonomy, and relatedness.
Test whether the SDT constructs of competence, autonomy and relatedness mediate the effects of NextSTEPS on patient/caregiver outcomes as hypothesized.
Explore whether sociodemographic (e.g., age, gender), medical (e.g., disease stage, comorbidities), and relationship factors (e.g., whether the caregiver is a spouse/partner or other family member) moderate the effects of NextSTEPS on patient/caregiver competence, autonomy, and relatedness.
NextSTEPS fills an important service gap by providing education, skills training, and support to advanced cancer patients and their caregivers shortly after diagnosis. Home-based telephone delivery will facilitate dissemination and outreach. By empowering families with the skills they need to coordinate care and meet the challenges of advanced cancer together, NextSTEPS holds great promise for improving patient and caregiver QOL, and the quality of palliative and supportive care in cancer.
- Conditions
- Lung Cancer, Gastrointestinal Cancer
- Being tested
- NextSteps
- Medical subject headings
- Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NextStepsBehavioural
Intervention sessions are delivered by a Masters level trained interventionist. During sessions, the interventionist will: conduct the weekly symptom screen, review content, answer questions, ensure skills mastery through homework review, and work with participants to develop action plans and identify/overcome barriers to self-care/caregiving. Patients and caregivers will receive individual calls from the interventionist for sessions 1, 2, and 3, and participate together for sessions 4, 5, and 6 via speakerphone.
| Study group | Role | What they receive |
|---|---|---|
| NextSteps Intervention | Experimental | Patients and caregivers will each receive their own tailored manual and six weekly 45-minute telephone calls that correspond to the manual, delivered by a Masters level trained interventionist. Receives: Behavioral: NextSteps |
| Usual Medical Care | No intervention | UMC consists of standard oncologic care for the patient from the point of diagnosis of advanced cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Caregiver Depression
Patient Reported Outcomes Measurement Information System Depression 6 item Short form
Measured: 2 months
Patient and Caregiver Anxiety
Patient Reported Outcomes Measurement Information System Anxiety 6 item Short form
Measured: 2 months
Secondary outcomes (4)
Patient and Caregiver Satisfaction with Care
20-item Family Satisfaction with Care (FAMCARE) scale
Measured: 2 months, 4 months, and 6 months
Patient Symptom Burden
M D Anderson Symptom Inventory
Measured: 2 months, 4 months, and 6 months
Patient and Caregiver Depression
Patient Reported Outcomes Measurement Information System Depression 6 item Short form
Measured: 4 and 6 months
Patient and Caregiver Anxiety
Patient Reported Outcomes Measurement Information System Anxiety 6 item Short form
Measured: 4 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jul 2015
- Primary completion1 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Badr, Baylor College of Medicine
- Investigators
- Hoda Badr, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885439
- Sponsor's protocol ID
- H-39002
- Status last verified
- Apr 2024
- First submitted
- 10 May 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NextSteps: A Supportive Care Program For Advanced Cancer Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT04885439
- Acronym / sponsor ID
- H-39002
- Conditions
- Lung Cancer, Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 May 2021 (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 study seeks to test the efficacy of a psychosocial intervention to empower advanced cancer patients and their caregivers and improve their quality of life (QOL). The program, called NextSTEPS, provides skills training in six domains that are central to patient and caregiver QOL: self-care, stress management, symptom management, effective communication, problem-solving, and social support.
Detailed description
In this study, 200 advanced cancer patients who are within one month of treatment initiation (baseline) and their caregivers will complete baseline surveys and be randomized to NextSTEPS or a usual medical care (UMC) condition. In addition to UMC, patients and caregivers in the NextSTEPS condition will each receive an intervention manual and six weekly 45-minute telephone counseling sessions with a trained interventionist. Patients and caregivers in both the NextSTEPS and UMC conditions will complete follow-up surveys at 8 weeks (primary endpoint), and 4 and 6 months post-baseline (secondary endpoints).
The specific aims are to:
- Determine the impact of NextSTEPS on patient physical and emotional QOL, palliative care utilization, and satisfaction with care relative to UMC. We hypothesize that at 8 weeks (2 months), and 4 and 6 months, patients in NextSTEPS will have less symptom burden, less emotional distress, greater palliative care utilization, and greater satisfaction with care relative to patients in UMC.
- Determine the impact of NextSTEPS on caregiver self-care, physical and emotional QOL, and satisfaction with care. We hypothesize that at 8 weeks, and 4 and 6 months, caregivers in NextSTEPS will report more self-care, better physical QOL, less emotional distress, and greater satisfaction with care relative to caregivers in UMC.
Secondary/exploratory aims and hypotheses are to:
Examine the effects of the NextSTEPS intervention on Self Determination Theory (SDT) constructs. We hypothesize that NextSTEPS will enhance patient and caregiver competence, autonomy, and relatedness.
Test whether the SDT constructs of competence, autonomy and relatedness mediate the effects of NextSTEPS on patient/caregiver outcomes as hypothesized.
Explore whether sociodemographic (e.g., age, gender), medical (e.g., disease stage, comorbidities), and relationship factors (e.g., whether the caregiver is a spouse/partner or other family member) moderate the effects of NextSTEPS on patient/caregiver competence, autonomy, and relatedness.
NextSTEPS fills an important service gap by providing education, skills training, and support to advanced cancer patients and their caregivers shortly after diagnosis. Home-based telephone delivery will facilitate dissemination and outreach. By empowering families with the skills they need to coordinate care and meet the challenges of advanced cancer together, NextSTEPS holds great promise for improving patient and caregiver QOL, and the quality of palliative and supportive care in cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NextSteps Intervention | Experimental | Behavioral: NextStepsPatients and caregivers will each receive their own tailored manual and six weekly 45-minute telephone calls that correspond to the manual, delivered by a Masters level trained interventionist. |
| Usual Medical Care | No intervention | –UMC consists of standard oncologic care for the patient from the point of diagnosis of advanced cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has stage 3A, 3B, or 4 NSLC or extensive stage SCLC and is within one month of treatment initiation OR patient has Stage 4 GI cancer and is within one month of treatment initiation
- patient is spending more than 50% of time out of bed on a daily basis as measured by an ECOG Performance Status rating of level 0, 1, or 2
- patient has stable brain metastases and no limitation on hepatic or renal function
- patient has a spouse/partner other or close family member who he/she defines as the primary caregiver
- patient and caregiver are age 18 years or older
Key exclusion criteria (2 listed)
- patient or caregiver is deaf or has significant hearing impairment and thus cannot use the telephone
- patient is currently enrolled in hospice.
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 |
|---|---|---|
| NextStepsIntervention sessions are delivered by a Masters level trained interventionist. During sessions, the interventionist will: conduct the weekly symptom screen, review content, answer questions, ensure skills mastery through homework review, and work with participants to develop action plans and identify/overcome barriers to self-care/caregiving. Patients and caregivers will receive individual calls from the interventionist for sessions 1, 2, and 3, and participate together for sessions 4, 5, and 6 via speakerphone. | Behavioural | NextSteps Intervention |
Primary outcome
Patient and Caregiver Depression
Time frame: 2 months
Patient Reported Outcomes Measurement Information System Depression 6 item Short form
Patient and Caregiver Anxiety
Time frame: 2 months
Patient Reported Outcomes Measurement Information System Anxiety 6 item Short form
4 secondary outcomes
Patient and Caregiver Satisfaction with Care
Time frame: 2 months, 4 months, and 6 months
Patient Symptom Burden
Time frame: 2 months, 4 months, and 6 months
Patient and Caregiver Depression
Time frame: 4 and 6 months
Patient and Caregiver Anxiety
Time frame: 4 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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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.
Hoda Badr, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NextSteps in people with Lung Cancer and Gastrointestinal Cancer, run by Baylor College of Medicine 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 7 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: finished, as of the sponsor's last update on 22 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient and Caregiver Depression (time frame: 2 months). The study lists 2 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 22 Apr 2024.