Clinical trial NCT04885439: NextSteps Intervention for Advanced Cancer Patients and Caregivers
Official title: NextSteps: A Supportive Care Program For Advanced Cancer Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Gastrointestinal Cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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, 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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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
3. patient has stable brain metastases and no limitation on hepatic or renal function
4. patient has a spouse/partner other or close family member who he/she defines as the primary caregiver
5. patient and caregiver are age 18 years or older
6. 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
7. patient and caregiver can provide informed consent

Exclusion Criteria:

1. patient or caregiver is deaf or has significant hearing impairment and thus cannot use the telephone
2. patient is currently enrolled in hospice.

Primary outcomes:
measure: Patient and Caregiver Depression
timeFrame: 2 months
measure: Patient and Caregiver Anxiety
timeFrame: 2 months
Secondary outcomes:
measure: Patient and Caregiver Satisfaction with Care
timeFrame: 2 months, 4 months, and 6 months
measure: Patient Symptom Burden
timeFrame: 2 months, 4 months, and 6 months
measure: Patient and Caregiver Depression
timeFrame: 4 and 6 months
measure: Patient and Caregiver Anxiety
timeFrame: 4 and 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Hoda Badr, PhD
role: PRINCIPAL_INVESTIGATOR
References: