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Lung CancerNCT02414672

CareSTEPS: A Supportive Care Program for the Caregivers of Advanced Lung Cancer Patients

A study testing CareSTEPS in people with Lung Cancer, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The CareSTEPS intervention fills an important service gap by providing education, skills training, and support to the caregivers of advanced lung cancer patients on active treatment. The home-based delivery format will facilitate future dissemination and outreach. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
CareSTEPS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
1 siteUnited States
Study dates
Nov 2014to Dec 2020
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has stage 3B or 4 NSLC or extensive stage SCLC 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 a spouse/partner other or close family member who he/she defines as the primary caregiver
  • Patient and caregiver > 18 years
  • Patient/caregiver has the ability to read and understand English at a sixth grade level, as determined by his/her ability to understand the consent form
  • Patient/caregiver can provide informed consent

Who cannot join

  • Individuals with diminished mental capacity
  • Prisoners
  • Children
  • Pregnant Women
  • Fetuses

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

The CareSTEPS intervention fills an important service gap by providing education, skills training, and support to the caregivers of advanced lung cancer patients on active treatment. The home-based delivery format will facilitate future dissemination and outreach. By empowering families with the skills they need to provide care and meet the challenges of lung cancer, this intervention holds great promise for improving caregiver quality of life (QOL), patient QOL, and the quality of palliative and supportive care services offered to patients with advanced cancer and their families.

Read the detailed description

The profound symptom burden associated with advanced lung cancer (LC) makes caregiving a complex and burdensome task. Despite the input of outpatient palliative care services, LC families are often unprepared for caregiving, have low self-efficacy for managing symptoms at home, report high rates of physical and emotional distress, and receive very little skills training or psychosocial care. To date, the few psychosocial intervention trials targeting the caregivers of advanced cancer patients that have been conducted have mostly targeted the families of hospice patients, have not been well-integrated into routine palliative care, and have not addressed the specific needs of LC caregivers. Based on our published and recently completed pilot work in LC, the investigators have developed a psychosocial intervention called CareSTEPS (self-Care, Stress management, sympTom management, Effective communication, Problem-solving, and Social support). CareSTEPS is grounded by Self Determination Theory (SDT) which focuses on individuals' needs for developing autonomy (a sense of choice and volition), competence (self-efficacy), and relatedness (a sense of belonging and connection). It: 1) teaches skills to enhance caregiver competence for managing symptoms, practicing self-care, and coping with cancer; 2) supports caregiver autonomy by providing a clear rationale for recommendations and a variety of options to encourage choice and elaboration; and, 3) seeks to improve caregivers' sense of relatedness by teaching strategies for effective communication and soliciting/accepting social support. 200 LC patients will be enrolled within one month of treatment initiation (baseline) and their caregivers and randomize them to either a usual medical care (UMC) condition or the CareSTEPS intervention (caregivers receive a manual and six 45-minute weekly counseling sessions by telephone). The primary aim is to determine the impact of the CareSTEPS intervention on caregiver self-care behaviors, physical and emotional QOL, and satisfaction with care. Secondary aims are to: 1a) examine the effects of CareSTEPS on the SDT constructs of competence, autonomy, and relatedness; 1b) test whether caregiver competence, autonomy and relatedness mediate the effects of CareSTEPS on caregiver outcomes as hypothesized; 2) explore whether sociodemographic, medical, and relationship factors moderate the effects of the CareSTEPS intervention on SDT constructs; and, 3) explore the effects of CareSTEPS on patient QOL, palliative care utilization, and satisfaction with care. CareSTEPS fills an important service gap by providing education, skills training, and support to the caregivers of advanced LC patients who are on active treatment. The home-based delivery format will facilitate future dissemination and outreach. By empowering families with the skills they need to provide care and meet the challenges of LC, CareSTEPS holds great promise for improving caregiver QOL, patient QOL, and the quality of palliative/supportive care services for advanced cancer patients and their families.

Conditions
Lung Cancer
Being tested
CareSTEPS
Keywords
psychosocial intervention, advanced lung cancer, caregivers, self-care
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CareSTEPSBehavioural

    Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist.

Study groups in NCT02414672
Study groupRoleWhat they receive
CareSTEPSExperimentalCareSTEPS provides skills training in six domains that are central to the caregiving role: self-care, stress management, symptom management, effective communication, problem-solving, and social support.
Receives: Behavioral: CareSTEPS
Usual Medical Care (UMC)No interventionPatients receive standard oncologic and generalist palliative care from their healthcare team.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregiver Depression

    PROMIS Depression Short Form

    Measured: 8 weeks

  2. Caregiver Anxiety

    PROMS Anxiety Short form

    Measured: 8 weeks

Secondary outcomes (4)
  1. Caregiver burden

    Zarit Burden Interview

    Measured: 8 weeks and 6 months

  2. Patient emotional quality of life

    PROMIS Depression and Anxiety Short Forms

    Measured: 8 weeks and 6 months

  3. Caregiver Depression

    PROMIS Depression Short Form

    Measured: 6 months

  4. Caregiver Anxiety

    PROMIS Anxiety Short Form

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2020
  4. Study completionDec 2020

Resources

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
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414672
Sponsor's protocol ID
H-38998
Other IDs
R01CA187143
Status last verified
Apr 2024
First submitted
7 Apr 2015
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Rangel ML, Milbury K, Kayser K, Ripley RT, Kvale E, Badr H. Multisite Randomized Controlled Trial of CareSTEPS: A Supportive Care Intervention for the Family Caregivers of Patients With Advanced Lung Cancer. JTO Clin Res Rep. 2024 Oct 17;5(12):100736. doi: 10.1016/j.jtocrr.2024.100736. eCollection 2024 Dec.

    PubMed 39583146

Questions about this trial

What is this clinical trial studying?

A study testing CareSTEPS in people with Lung 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 6 inclusion and 5 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?

Caregiver Depression (time frame: 8 weeks). 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?

On the ClinicalTrials.gov record for NCT02414672, which also lists 1 linked publication.

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.

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